E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prevention of alveolar osteitis after third molar extraction |
Alveolārā osteīta novēršana pēc trešā dzerokļa ekstrakcijas |
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E.1.1.1 | Medical condition in easily understood language |
Prevention of alveolar osteitis after third molar extraction |
Alveolārā osteīta novēršana pēc trešā dzerokļa ekstrakcijas |
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E.1.1.2 | Therapeutic area | Diseases [C] - Mouth and tooth diseases [C07] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10066995 |
E.1.2 | Term | Alveolar osteitis |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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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 demonstrate the efficacy of chlorhexidine mouthwash in the prevention of alveolar osteitis following third molar extraction. |
Pierādīt hlorheksidīna mutes skalojamā līdzekļa efektivitāti alveolārā osteīta novēršanā pēc trešā dzerokļa ekstrakcijas |
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E.2.2 | Secondary objectives of the trial |
To evaluate the safety and the local tolerability of DC071. |
Izvērtēt DC071 lietošanas drošumu un vietēju panesamību |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Male or female, over 18 years old - Subject needing to undergo extraction of one impacted mandibular third molar - For woman of childbearing potential and for woman in menopausal period under hormonal substitution treatment, she must accept to plan the extraction of the impacted mandibular third molar only during the last week of the menstrual cycle - Affiliated to a social security system, or is a beneficiary (if applicable in the national regulation)
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E.4 | Principal exclusion criteria |
- Existence or history of parotid gland disorders - Acute or history of recent acute pericoronitis at any tooth - Extraction of more than 1 third molar in the same surgical procedure - Subject at high risk of bacterial endocarditis (prosthetic heart valve, history of bacterial endocarditis, congenital cyanogenic heart disease) - Coagulation or haemostatic disorder or use of anticoagulants - Hypersensitivity to chlorhexidine or any of the excipients; - Hypersensitivity to any anesthetic agent; - Hypersensitivity to corticosteroids, analgesics including opioid drugs used for post-surgery pain relief - Intake of systemic vasodilator or vasoconstrictor - Intake of systemic or local (in the mouth) antibiotics within 7 days before Day 1 and/or any pre- or post-operative antibiotic prophylaxis planned to be prescribed during the study; - Use of any antiseptic mouthwash within 7 days before Day -1 - Regular heavy smokers (more than 20 cigarettes per day) - Is pregnant or in post-partum period or a nursing mother
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E.5 End points |
E.5.1 | Primary end point(s) |
Occurence of an alveolar osteitis (dry socket) within the 7 days after the extraction of the impacted mandibular third molar. Alveolar osteitis will be recorded at Visit 4 (End-of-Study visit).
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
General tolerance by recording of adverse events recorded at each visit.
Local tolerance assessment by the investigator by mouth examination performed by the investigator at V2 (Inclusion visit), V3 (D1 before surgery) and V4 on a 4-point scale (none, mild, moderate or severe) on erythema, oedema, ulceration.
Subject’s global tolerability performed at V4 on a 4-point rating scale (very well tolerated, well tolerated, rather not tolerated, not tolerated at all).
Overall assessments Investigator’s overall assessment performed at V4 on a 4-point rating scale (very good, good, moderate, poor)
Subject’ satisfaction assessment of tested product performed at V4 on a 6-point rating scale (very satisfied, satisfied, rather satisfied, rather not satisfied, not satisfied, not satisfied at all).
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
V2(D-7 to D-2), V3 (D1) and V4 (D8) |
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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 | No |
E.6.4 | Safety | Yes |
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) | No |
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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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 | Yes |
E.8.2.3 | Other | No |
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 10 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 30 |
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
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LVLS = 31st March 2016 |
LVLS = 31st March 2016 |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 2 |
E.8.9.2 | In all countries concerned by the trial days | 0 |