E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
If the application of L-PRF with respect to the use of DBBM shows that there are differences in the percentage of new bone between the LPRF group and the control group at 4 and 6 months |
Si la aplicación de L-PRF con respecto al uso de DBBM muestra que haya diferencias en el porcentaje de nuevo hueso entre el grupo del LPRF y el grupo control a los 4 y 6 meses |
|
E.1.1.1 | Medical condition in easily understood language |
If a blood derivative helps in the percentage of new bone formed compared to a bone substitute. |
Si un derivado de la sangre ayuda en el porcentaje de nuevo hueso formado en comparación con un sustituto óseo |
|
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 | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate whether the use of L-PRF combined with deproteinized bovine mineralized bone (DBBM; BioOss, Geistlich Pharma®) improves the efficacy of DBBM in bone regeneration in maxillary sinus augmentation by reducing healing time, through histomorphometric and histologic analysis of bone biopsies after maxillary sinus lift versus the use of deproteinized bovine mineralized bone (DBBM) alone. |
Evaluar si el uso de L-PRF combinado con hueso desproteinizado mineral bovino (DBBM; BioOss, Geistlich Pharma®) mejora la eficacia del DBBM en la regeneración ósea en el aumento del seno maxilar reduciendo el tiempo de cicatrización, a través del análisis histomorfométrico y histológico de biopsias de hueso tras la elevación de seno maxilar frente al uso de hueso desproteinizado mineral bovino (DBBM) solo. |
|
E.2.2 | Secondary objectives of the trial |
Evaluate volumetric changes at 4 months and 1 year by CBCT measurements. |
Evaluar los cambios volumétricos a los 4 meses y al año mediante mediciones de los CBCT. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients >18 years;
Presence of oral health (periodontally healthy or periodontitis treated) - with bleeding on probing (BoP) <20% and plaque index (PI) <20%;
Systemically healthy, with no disease that would contraindicate oral surgery;
Non-smokers or smokers of <10 cig/day;
Not pregnant or breastfeeding;
Need to place implants in postero-superior sector with a residual bone height of < 5mm (no need for vertical regeneration);
More than 3 months since tooth extraction in the treatment area;
Absence of sinus pathology |
Pacientes >18 años; Presencia de salud oral (periodontalmente sanos o con periodontitis tratada) - con un sangrado al sondaje (BoP) <20% y un índice de placa (IP) <20%;
Sistémicamente sanos, sin ninguna enfermedad que pueda contraindicar una cirugía oral;
No fumadores o fumadores de <10 cig/día;
No embarazo ni lactancia;
Necesidad de colocar implantes en sector postero-superior con una altura de hueso residual de < 5mm (sin necesidad de regeneración vertical);
Más de 3 meses desde la extracción de dientes en la zona de tratamiento; Ausencia de patología sinusal |
|
E.4 | Principal exclusion criteria |
Patients who, due to systemic conditions, blood collection is not possible;
Medication that may interfere with bone metabolism (e.g., corticosteroids, bisphosphonates);
History of radiotherapy. |
Pacientes que por condiciones sistémicos no sea posible la extracción de sangre;
Medicación que pueda interferir en el metabolismo óseo (por ejemplo, corticoesteroides, bifosfonatos);
Historia de radioterapia. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Percentage of new bone formed after treatment by histological and histomorphometric measurement of biopsies. |
Porcentaje de hueso nuevo formado tras el tratamiento mediante la medición histológica e histomorfométrica de las biopsias |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
At 4 and 6 months |
A los 4 y 6 meses |
|
E.5.2 | Secondary end point(s) |
percentage of remnant material; alveolar ridge volumetric changes (width, height, thickness) by CBCT; Implant stability (ISQ>65) |
porcentaje de material remante; cambios volumétricos cresta alveolar (anchura, altura, espesor) mediante CBCT; Estabilidad del implante (ISQ>65) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
CBCT at 4 and 12 months;
ISQ at 4 and 6 months |
CBCT a los 4 y 12 meses;
ISQ a los 4 y 6 meses |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Hueso desproteinizado mineral bovino (DBBM) |
Deproteinized bovine bone mineral (DBBM) |
|
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |