Clinical Trials Register

Summary
EudraCT Number:	2017-001068-39
Sponsor's Protocol Code Number:	ECPAF11/16
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2017-08-08
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2017-001068-39

A.3

Full title of the trial

Changes in the bone morphology of the post-extraction socket, preserved with platelet-rich fibrin and leukocytes (L-PRF) versus Conventional treatment

Cambios en la morfología ósea del alveolo posextracción, preservado con fibrina rica en plaquetas y leucocitos (L-PRF) vs. tratamiento convencional

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Changes in the bone after a tooth extraction and filling the space with a product obtained from the patient's blood (L-PRF) against the conventional treatment

Cambios en el hueso después de la extracción de un diente y rellenado el espacio con un producto obtenido de la sangre del paciente (L-PRF) frente al tratamiento convencional

A.4.1

Sponsor's protocol code number

ECPAF11/16

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	OMEQUI
B.1.3.4	Country	Spain
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	OMEQUI
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	University of Santiago de Compostela. Faculty of Medicine and Dentistry
B.5.2	Functional name of contact point	Master of Periodontics. USC
B.5.3	Address:
B.5.3.1	Street Address	c/Entrerríos sn
B.5.3.2	Town/ city	Santiago de Compostela
B.5.3.3	Post code	15782
B.5.3.4	Country	Spain
B.5.5	Fax number	34981562226
B.5.6	E-mail	lourdes.novoa@rai.usc.es

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	L-PRF (INTRASPIN SYSTEM )
D.2.1.1.2	Name of the Marketing Authorisation holder	Mary L. Jean
D.2.1.2	Country which granted the Marketing Authorisation	Spain
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	L-PRF
D.3.2	Product code	IS220
D.3.4	Pharmaceutical form	Periodontal insert
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Buccal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	leukocytes and platelet rich fibrin
D.3.9.2	Current sponsor code	IS220
D.3.9.3	Other descriptive name	PLASMA
D.3.9.4	EV Substance Code	SUB118891
D.3.10	Strength
D.3.10.1	Concentration unit	U unit(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	1 to 6
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	Yes
D.3.11.8	Extractive medicinal product	Yes
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	GEISTLICH BIO-OSS® COLLAGEN
D.2.1.1.2	Name of the Marketing Authorisation holder	INIBSA DENTAL
D.2.1.2	Country which granted the Marketing Authorisation	Spain
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	GEISTLICH BIO-OSS® COLLAGEN
D.3.2	Product code	G:20.03.2012
D.3.4	Pharmaceutical form
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Dental use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Demineralized bovine bone mineral with 10% of collagen
D.3.9.2	Current sponsor code	G:20.03.2012
D.3.9.3	Other descriptive name	HYDROXYAPATITE
D.3.9.4	EV Substance Code	SUB77913
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	100
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	Yes
D.3.11.13.1	Other medicinal product type	Demineralized bovine bone mineral with 10% of collagen

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Regenerative potential of L-PRF

potencial regenerador del L-PRF

E.1.1.1

Medical condition in easily understood language

Ability of the L-PRF to regenerate with bone the remaining space after removing a
tooth

capacidad del L-PRF de regenerar con hueso el espacio que queda tras extraer un
diente

E.1.1.2

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Dentistry [E06]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To determine if there are differences in the horizontal radiographic bone gain at 1
mm from the most coronal crestal portion by means of the Computed Tomography
CT scan at 3 months after alveolar preservation post-extraction between two
treatment modalities: the use of L- PRF or DBBM-C / PG (demineralized bovine
bone mineral with collagen and covered by connective tissue graft)

Determinar si existen diferencias en la ganancia ósea horizontal radiográfica a 1mm
de la porción crestal más coronal mediante el estudio de Tomografía
Computarizada de haz cónico (TC) a los 3 meses tras realizar preservación alveolar
posextracción entre dos modalidades de tratamiento: la utilización de L-PRF o
DBBM-C/PG (hueso desmineralizado de origen bovino con colágeno cubierto por
injerto de tejido conectivo)

E.2.2

Secondary objectives of the trial

To estimate the possible differences between the modalities of preservation applied
by CT by assessing the osseo-crest changes in the horizontal direction (vestibular,
palatal and total crest) at 3 and 5 mm apical to the most coronal alveolar crest, and
vertically (vestibular crest, palatine And midpoint of the socket). Likewise, we will
analyze the volumetric crest changes observed when comparing previous study
models and at 3 months post-extraction using image digitalization techniques.
Assessment of postoperative morbidity, healing and adherence to postoperative
guidelines given

Estimar las posibles diferencias entre las modalidades de preservación aplicadas
mediante TC valorando los cambios óseo-crestales en sentido horizontal (cresta
vestibular, palatina y total) a 3 y 5mm apicales a la cresta alveolar más coronal, y
en sentido vertical (cresta vestibular, palatina y punto medio del alveolo). Así
mismo, se analizarán los cambios volumétricos crestales observados al comparar
modelos de estudio previos y a los 3 meses posextracción mediante técnicas de
digitalización de imagen. Valoración de la morbilidad posoperatoria, cicatrización y
cumplimiento de las pautas posoperatorias dadas

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Patients older than 18 years Presence of oral health with plaque index and bleeding
not exceeding 25%. Need to perform dental extraction in anterosuperior zone
involving teeth in position 15 - 25 (both included) Presence of more than 60% of the
bone at the radiographic level

Pacientes mayores de 18 años Presencia de salud bucodental con índice de placa
y sangrado no superior al 25%. Necesidad de realizar extracción dental en zona
anterosuperior abarcando dientes en posición 15 – 25 (ambos incluidos) Presencia
de más del 60% del hueso a nivel radiográfico

E.4

Principal exclusion criteria

Smokers of more than 20 cigarettes Presence of medical pathology that prevents
the application of the treatments, has an impact on the response of these and the
healing process: protein and vitamin deficiency, therapeutic radiation, metabolic
disorders (diabetes, hypercalcemia ...), drug disorders (antimetabolic,
immunosuppressive) And hormonal, allergy to some component of the treatments
applied in the study.

Fumadores de más de 20 cigarrillos Presencia de patología médica que impida la
aplicación de los tratamientos, repercuta en la respuesta de estos y el proceso de
cicatrización: déficit proteico y vitamínico, radiación terapéutica, trastornos
metabólicos (diabetes, hipercalcemia...), trastornos medicamentosos
(antimetabólicos, inmunosupresores) y hormonales, alergia a algún componente de
los tratamientos aplicados en el estudio.

E.5 End points

E.5.1

Primary end point(s)

Radiographic bone changes horizontally 1 mm from the crest (HW-1C)

cambios óseos radiográficos en sentido horizontal a 1mm de la cresta (HW-1C)

E.5.1.1

Timepoint(s) of evaluation of this end point

At baseline and at 3 months after treatment

al inicio y a los 3 meses tras el tratamiento

E.5.2

Secondary end point(s)

CLINICS: Ii) changes in alveoli depth in mm at 3 months of healing; Iii) dimensional
changes at 3 months of healing among the study models obtained; Iv) evaluation of
compliance with postoperative guidelines and intensity of pain after the intervention
(1st and 2nd postoperative weeks); Vi) level of healing of the area involved,
complications and level of oral hygiene (1st, 2nd and 12th week post-treatment);
Age, sex, number of daily cigarettes consumed (evaluated at baseline); Extraction
tooth position, dental extraction motif, periodontal biotype, antibiotic prophylaxis
(evaluated on the day of treatment). RADIOGRAPHICS: (HW-3C and HW-5C) and
changes in the thickness of each cortical for the 3 levels studied (BHW-1C,
BHW-3C, BHW-5C: cortical Vestibular, PHW-1C, PHW-3C, PHW-5C: cortical
palatine). Viii) vertical changes in vestibular and palatal ridge (BH and PH); Ix)
vertical bone filling of the alveoli (AF).

CLÍNICAS: ii) cambios en la profundidad del alveolo en mm a los 3 meses de
cicatrización; iii) cambios dimensionales a los 3 meses de cicatrización entre los
modelos de estudio obtenidos; iv) valoración del cumplimiento de las pautas
posoperatorias e intensidad del dolor tras la intervención (1ª y 2ª semana
posquirúrgica); vi) nivel de cicatrización de la zona intervenida, complicaciones y
nivel de higiene bucal (1ª, 2ª y 12ª semana postratamiento); edad, sexo, número de
cigarrillos diarios consumidos (evaluadas al inicio); posición del diente de
extracción, motivo de extracción dental, biotipo periodontal, profilaxis antibiótica
(evaluadas el día del tratamiento). vii) cambios óseos en horizontal a 3 y 5mm de la
cresta alveolar (HW-3C y HW-5C) y cambios en el grosor de cada cortical para los
3 niveles estudiados (BHW-1C, BHW-3C, BHW-5C: cortical vestibular; PHW-1C,
PHW-3C, PHW-5C: cortical palatina). viii) cambios verticales en cresta vestibular y
palatina (BH y PH); ix) relleno óseo vertical del alveolo (AF).

E.5.2.1

Timepoint(s) of evaluation of this end point

RADIOGRÁFICAS: They are evaluated at the beginning and at 3 months
post-treatment. CLINICS: Ii) changes in alveoli depth in mm at 3 months of healing;
Iii) dimensional changes at 3 months of healing among the study models obtained;
Iv) evaluation of compliance with postoperative guidelines and intensity of pain after
the intervention (1st and 2nd postoperative weeks); Vi) level of healing of the area
involved, complications and level of oral hygiene (1st, 2nd and 12th week
post-treatment); Age, sex, number of daily cigarettes consumed (they would be
evaluated at baseline); Extraction tooth position, dental extraction motif, periodontal biotype, antibiotic prophylaxis (they would be evaluated on the day of treatment).

RADIOGRÁFICAS: Se evalúan al inicio y a los 3 meses postratamiento. CLÍNICAS:
ii) cambios en la profundidad del alveolo en mm a los 3 meses de cicatrización; iii)
cambios dimensionales a los 3 meses de cicatrización entre los modelos de estudio
obtenidos; iv) valoración del cumplimiento de las pautas posoperatorias e
intensidad del dolor tras la intervención (1ª y 2ª semana posquirúrgica); vi) nivel de
cicatrización de la zona intervenida, complicaciones y nivel de higiene bucal (1ª, 2ª
y 12ª semana postratamiento); edad, sexo, número de cigarrillos diarios
consumidos (evaluadas al inicio); posición del diente de extracción, motivo de
extracción dental, biotipo periodontal, profilaxis antibiótica (evaluadas el día del
tratamiento).

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

Yes

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

final del ensayo

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

none

ninguno

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2018-07-24

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-07-12

P. End of Trial
P.	End of Trial Status	Ongoing

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