Status:
COMPLETED
Autogenous vs. Xenogeneic Peri-implant Soft Tissue Grafts Placed in Full vs. Split Thickness Flaps
Lead Sponsor:
Universidad Complutense de Madrid
Collaborating Sponsors:
Osteology Foundation
Conditions:
Thin Gingiva
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Randomized, outcome assessor and data analyst blinded, single center trial with four parallel arms and a 1:1:1:1 allocation ratio, with the aim of comparing which combination of bilaminar technique (s...
Detailed Description
This randomized four parallel arms controlled clinical trial with blinded outcome assessment and data analysis aims to establish which combination of bilaminar technique (split vs. full thickness flap...
Eligibility Criteria
Inclusion
- Any male or female adult (≥ 18 year old) patient from the University Complutense of Madrid, being able to sign an informed consent form, presenting a submerged dental implant scheduled to undergo a second stage surgery, which is bounded mesially or distally by a remaining natural tooth, and exhibits a lack of buccal soft tissue volume, will be potentially eligible for this trial.
- The case definition for a lack of buccal soft tissue volume will be the presence of a thin buccal mucosa (\< 2mm) or a minor volumetric contraction of the alveolar process (flat or concave buccal mucosal profile at the edentulous area).
Exclusion
- Patients fitting to all the above inclusion criteria will be not included in 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 during enrolment or 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);
- Assumption of bisphosphonates (any type, any dose, past or present);
- Pregnant or nursing women;
- Hypersensitivity to paracetamol;
- Local primary exclusion criteria
- History of previous mucogingival surgeries in the area of interest;
- Lack of adequate vestibule depth to perform a bilaminar procedure;
- Lack of osseointegration at the time of implant reopening;
- Need for additional bone grafting at the time of implant reopening;
- Intraoperative evidence of a flap thickness \< 0,5mm or \> 2mm.
- Secondary exclusion criteria:
- \- Non compliant patients: poor oral hygiene at 2 consecutive visits.
Key Trial Info
Start Date :
January 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05211115
Start Date
January 24 2022
End Date
December 1 2024
Last Update
December 19 2024
Active Locations (1)
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1
Department of Periodontology, University Complutense Madrid, Spain
Madrid, Spain, 28040