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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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2 August 2021 |
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Main ID: |
EUCTR2005-000869-20-ES |
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Date of registration:
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09/06/2005 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Post-operative care by chlorhexidine mouthwash after periodontal surgery. Randomised, parallel groups; blind study, DC071BB versus placebo, in patients presenting with periodontal surgery with suture.
Cuidado post-operatorio mediante un colutorio de clorhexidina tras una cirugía periodontal. Estudio ciego, en grupos paralelos, aleatorizado, DC071BB versus placebo, en pacientes que presenten cirugía periodontal con sutura
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Scientific title:
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Post-operative care by chlorhexidine mouthwash after periodontal surgery. Randomised, parallel groups; blind study, DC071BB versus placebo, in patients presenting with periodontal surgery with suture.
Cuidado post-operatorio mediante un colutorio de clorhexidina tras una cirugía periodontal. Estudio ciego, en grupos paralelos, aleatorizado, DC071BB versus placebo, en pacientes que presenten cirugía periodontal con sutura |
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Date of first enrolment:
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08/08/2005 |
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Target sample size:
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200 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-000869-20 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Estonia
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Latvia
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Spain
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
- Regular user of manual toothbrush (at least once a day),
- who have a periodontitis,
- who have a periodontal surgery (flap, debridment with access flap, complicated tooth extraction, alveolectomy) with a gingival suture or several sutures on the same area, concerning one or several teeth,
Are the trial subjects under 18? no
Number of subjects for this age range:
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) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
- Dental surgery such as: grafting of bone substitute material, membrane, gingivectomy, non complicated tooth extraction, scaling – root planning alone,
- any surgery that requires an antibiotic cover during or after the surgery,
- who have more than two teeth missing between the suture and an existing tooth,
- who have in the same time surgical procedures on different areas of the mouth,
- medical history of major medical, psychiatric illness or surgery which, in the judgement of the investigator, puts them ‘at risk’ or is likely to modify their handling of the study drug,
- severe acute or chronic systemic disease or disorder that should interfere with treatment or evaluation,
- any coagulation disorder,
- any buccal disorder which could interfere with the treatment or the evaluation (hyposalivation or asialia, aphtha, ulceration, lichen planus, stomatitis),
- history of alcohol or drug addiction.
- use of local antiseptics (mouthwash) within the 7 previous days,
- use of antibiotics (any route of administration) within the 7 previous days,
- smokers.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Post-operative care for patients having periodontal surgery with gingival suture.
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Intervention(s)
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Trade Name: ELUDRIL mouthwash
Product Code: DC071BB08b
Pharmaceutical Form: Mouth wash
INN or Proposed INN: Clorherxidrina digluconato
Concentration unit: % percent
Concentration type: equal
Concentration number: 0.1-
Pharmaceutical form of the placebo: Mouth wash
Route of administration of the placebo: Oromucosal use
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Primary Outcome(s)
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Secondary Objective: To evaluate the patient's satisfaction and the investigator's global judgement during the post-operative period.
To evaluate the suture healing.
To document the local and general tolerance.
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Main Objective: To assess the efficacy of DC071BB08b mouthwash for controlling the evolution of plaque index in per-surgical area during the post-operative period.
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Primary end point(s): Evolution of the plaque index in the peri-surgery area.
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Secondary ID(s)
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DC0071-BB-404-8B
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 06/07/2005
Contact:
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