RecruitingNot ApplicableNCT07714265

Soft Tissue Augmentation Around Dental Implants Using Connective Tissue Graft, Submerged Tenting Abutment, or Sub-crestal Implant Placement

Evaluation of Peri-implant Soft Tissue Thickness Following Augmentation Using Subepithelial Connective Tissue Graft Versus Submerged Tenting Abutment Versus Sub-crestal Implant Placement: A Randomized Controlled Clinical Trial


Sponsor

Misr International University

Enrollment

30 participants

Start Date

Jul 17, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 20 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Sub-crestal Implant Placement, a medical device called Submerged Tenting Abutment, and others for people with partial edentulism, peri-implant soft tissue deficiency, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREsubepithelial connective tissue graft

Harvesting of an autogenous connective tissue graft from the palate and placement over an equicrestally positioned dental implant to augment peri-implant soft tissue thickness.

DEVICESubmerged Tenting Abutment

Placement of a submerged low-profile tenting healing abutment over an equicrestally positioned dental implant to support peri-implant soft tissue during healing.

PROCEDURESub-crestal Implant Placement

Placement of a dental implant approximately 2 mm apical to the alveolar crest without soft tissue grafting or tenting abutment placement.


Locations(1)

Misr International University Dental Clinic Complex

Cairo, Egypt

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NCT07714265


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