Strip Graft w/ Xenogeneic Matrix vs Free Gingival Graft for the Augmentation of Peri-implant Keratinized Mucosa
Strip Graft With Xenogeneic Matrix Versus Free Gingival Graft for the Augmentation of Peri-implant Keratinized Mucosa: A Randomized Clinical Trial With Vascular Analysis
Universidad Complutense de Madrid
48 participants
Jan 29, 2024
INTERVENTIONAL
Conditions
Summary
The primary objective of this study is to compare changes in peri-implant keratinized mucosa (PIKM) following the application of apically repositioned flap (ARF) using a combination of a Strip graft and a Xenogeneic matrix, or with a free gingival graft (FGG), in implants in the second stage with \<2 mm of PIKM. Additionally, as a secondary objective, the investigators compare postoperative blood supply in both recipient and donor sites based on the type of graft obtained. Meanwhile, the investigators evaluate differences between the two groups concerning microcirculation values (perfusion units, PU), soft tissue thickness (STT), volume change, vestibular depth, as well as clinical, aesthetic, and patient-reported outcome measures (PROMS).
Eligibility
Inclusion Criteria4
- Patients older than 18 years
- Short-span dental implants in the mandible at second stage with inadequate PIKM (\<2 mm) with at least one adjacent tooth mesially
- Periodontally healthy patients with a pristine or reduced periodontium
- Plaque index (FMPS) less than 20%.
Exclusion Criteria6
- Compromised general health status that contraindicates study procedures (≥ASA III);
- Drug or alcohol abuse;
- Smoking of \> 10 cigarettes per day;
- Chronic use of corticosteroids, NSAIDs or immunomodulators (any type or dose);
- Pregnant or lactating women;
- History of previous mucogingival surgeries in the area of interest
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Interventions
An apically repositioned flap is made in the vestibular region. The flap is then elevated with a split-thickness preparation, and the mucogingival junction will be repositioned apically and fixed with periosteal-anchored sutures. Then, a free epithelialized gingival strip graft will be harvested from the molar area of the palate. The "Strip" graft is sutured to the apical end of the recipient bed. The remaining uncovered part of the periosteal bed will be covered with a xenogeneic collagen matrix (Mucograft®. Geistlich Pharma AG, Wolhusen, Switzerland) fixed with simple interrupted and crossed sutures. The edges of the palatal wound (donor area) will be approximated with crossed sutures.
The preparation of the apically repositioned flap and the recipient bed with its apico-coronal design and dimension is performed as in the test group. Subsequently, an epithelialized free gingival graft with the size of the entire recipient area with a thickness of 2 mm will be harvested from the molar area of the palate. The graft is sutured to the recipient periosteal bed using simple interrupted and crossed sutures. In the donor area, a collagen sponge is sutured to the wound by means of crossed sutures.
Locations(1)
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NCT06261268