Autogenous vs. Xenogeneic Peri-implant Soft Tissue Grafts Placed in Full vs. Split Thickness Flaps (NCT05211115) | Clinical Trial Compass
CompletedNot Applicable
Autogenous vs. Xenogeneic Peri-implant Soft Tissue Grafts Placed in Full vs. Split Thickness Flaps
Spain40 participantsStarted 2022-01-24
Plain-language 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 (split vs. full thickness flap) and graft type (autogenous or xenogeneic) provides better clinical, aesthetic, morphological, vascular and patients related outcomes, when augmenting the buccal peri-implant mucosa at the reopening of submerged implant fixtures
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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 Criteria:
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 vestibu…
What they're measuring
1
Buccal soft tissue thickness
Timeframe: before surgery, after surgery, 1 month after surgery, 6 months after surgery