Status:
COMPLETED
Harvest of Free Gingival Grafts With or Without the Application of Hemostatic Sutures
Lead Sponsor:
Universidad Complutense de Madrid
Conditions:
Thin-gingiva
Mucogingival Deformity on Edentulous Ridge
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Randomized, single-center trial with 2 parallel arms and a 1:1 allocation ratio, with the aim of comparing clinical and microvascular healing and patients related outcomes, which follow the harvest of...
Detailed Description
This randomized two parallel arms controlled clinical trial aims to establish the early microvascular healing, clinical healing, and patients related outcomes, which follow the harvest of a free gingi...
Eligibility Criteria
Inclusion
- Any adult (≥ 18 year old), male or female patient from the University Complutense of Madrid, being able to sign an informed consent form, presenting any mucogingival condition requiring the placement of a free gingival graft or a connective tissue graft obtained through the extra oral de-epithelialization of a free gingival graft.
Exclusion
- Patients fitting to all the above inclusion criteria will be excluded from the study if unable to attend to the study-related procedures (including the follow-up visits) or if one or more of the following systemic or local exclusion criteria will be found at any time through the study:
- Systemic primary exclusion criteria:
- Compromised general health status contraindicating the study procedures (≥ASA IV);
- Drug abuse, alcohol abuse, or smoking \> 10 cigarettes a day;
- Chronic use of corticosteroids, NSAIDs, or immune-modulators (any type, any dose);
- Use of anti-aggregant or anti-coagulant drugs;
- Pregnant or nursing women;
- Hypersensitivity to ibuprofen.
- Local primary exclusion criteria:
- History of previous soft tissue surgeries in the area of the harvest;
- Preoperative evidence of a palate thickness \< 2mm in the area of interest;
- Intraoperative evidence of active bleeding from the harvesting site at the end of surgery, which impedes the stabilisation of a good coagulum over the harvesting area;
- Secondary exclusion criteria:
- a. Non compliant patients: poor oral hygiene (FMPS \>20%) at 2 consecutive visits.
Key Trial Info
Start Date :
May 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2022
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT05381623
Start Date
May 20 2022
End Date
September 30 2022
Last Update
October 4 2023
Active Locations (1)
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1
Department of Periodontology, University Complutense Madrid, Spain
Madrid, Spain, 28040