Peri-implant soft tissue thickness is an important determinant of the long-term stability and success of dental implants. Patients with a thin peri-implant soft tissue phenotype are at increased risk of soft tissue recession, marginal bone loss, and compromised esthetic and functional outcomes. Subepithelial connective tissue graft (SCTG) is considered the gold standard for soft tissue augmentation; however, it requires harvesting tissue from the palate, increasing surgical complexity, operative time, and postoperative morbidity. Less invasive approaches, including submerged tenting abutments and subcrestal implant placement, have been proposed as alternatives to improve peri-implant soft tissue dimensions while reducing patient morbidity, but direct comparative clinical evidence remains limited.
This investigator-initiated, single-center, randomized, parallel-group clinical trial will compare three approaches for peri-implant soft tissue augmentation in patients with a thin peri-implant soft tissue phenotype requiring a single dental implant in the posterior mandible. Eligible implant sites will be randomly assigned in a 1:1:1 allocation ratio to receive either subepithelial connective tissue grafting, submerged tenting abutment placement, or subcrestal implant placement during implant surgery.
The primary objective is to compare changes in peri-implant soft tissue thickness using three-dimensional digital intraoral scanning over a 12-month follow-up period. Secondary objectives include evaluation of keratinized tissue width, clinical soft tissue thickness, histological characteristics of peri-implant soft tissue, peri-implant crestal bone level changes, postoperative pain, operative time, patient-reported satisfaction, and postoperative complications. The results of this study are expected to provide evidence regarding whether minimally invasive treatment approaches can achieve clinical outcomes comparable to connective tissue grafting while reducing surgical morbidity and improving patient-centered outcomes.
Inclusion Criteria:
Exclusion Criteria:
baraa2480582@miuegypt.edu.eg+201063278917
Blinding of participants and the operating surgeon is not feasible because of the nature of the surgical interventions. Outcome assessors responsible for clinical, digital, radiographic, and histological measurements will remain blinded to treatment allocation. Statistical analysis will also be performed by a blinded biostatistician.
Participants assigned to this arm will receive equi-crestal dental implant placement followed by augmentation of the peri-implant soft tissue using an autogenous subepithelial connective tissue graft harvested from the palate. The graft will be positioned over the implant site to increase peri-implant soft tissue thickness before primary flap closure.
Participants assigned to this arm will receive equicrestal dental implant placement followed by placement of a submerged low-profile tenting healing abutment beneath the flap to support peri-implant soft tissue contour during healing without connective tissue grafting.
Participants assigned to this arm will receive dental implant placement approximately 2 mm below the alveolar crest without connective tissue grafting or placement of a submerged tenting abutment.
zainab.hafez@miuegypt.edu.eg
Cairo, Egypt
baraa2480582@miuegypt.edu.eg+201063278917
zainab.hafez@miuegypt.edu.eg
Enhancing Soft Tissues Around Inserted Implants by Two Different Methods
Increased Peri-implant Keratinized Mucosal Thickness at Different Operative Times
Behavioral Comparison of Three Different Graft Materials to Increase Soft Tissue Thickness Around Dental Implants.
Subepithelial Connective Tissue Graft Versus Amniotic Chorion Membrane for Peri-implant Mucosal Thickness Enhancement
Peri-Implant Soft Tissue Augmentation Using a Free Connective Tissue Graft With an Epithelial Collar
Buccal Soft Tissue Contour Changes After Immediate Implant Placement with or Without Connective Tissue Graft
Soft Tissue Augmentation Around Dental Implants
Efficacy of Collagen Matrix for Peri-implant Soft Tissue Phenotype Modification