Status:
COMPLETED
Connective Tissue Graft Versus Collagen Matrix.
Lead Sponsor:
University of Parma
Conditions:
Gingival Diseases
Eligibility:
All Genders
Phase:
PHASE4
Brief Summary
Despite the potential role of soft tissue thickness in maintaining gingival margin stability, the existing literature has mainly focused on investigating the effect of different surgical techniques on...
Detailed Description
This is a pilot study and will include 8 visits over a minimum period of 25 weeks. The trial will follow the recommendations of the Consolidated Standards of Reporting Trials (CONSORT) statement and w...
Eligibility Criteria
Inclusion
- Systemically healthy males and females ≥ 18 years old
- Willingness to read and sign a copy of the Informed Consent Form after reading the Patient Information Sheet, and after the nature of the study has been fully explained
- Clinical evidence of a single gingival recession (RT1, RT2)
- Full mouth bleeding and plaque scores (FMBS and FMPS) \< 20% recorded
- Non-surgical treatment completed within 6 months prior to assessment for eligibility
Exclusion
- Medical history that includes diabetes or hepatic or renal disease, or other serious medical conditions or transmittable diseases (e.g. cardiovascular disease or AIDS).
- Antibiotic, anti-inflammatory or anticoagulant therapy during the month preceding the baseline exam.
- History of alcohol or drug abuse.
- Smoking ≥10 cigarettes a day
- Self-reported pregnancy or lactation (this criterion is due to oral tissue changes related to pregnancy and nursing which can affect interpretation of study results).
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into this trial.
- Taking medications that might induce gingival overgrowth (e.g. calcium antagonists)
Key Trial Info
Start Date :
January 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 18 2023
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT04678804
Start Date
January 20 2021
End Date
May 18 2023
Last Update
April 17 2025
Active Locations (1)
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1
Centro Universitario di Odontoiatria
Parma, Italy