NCT07714265 Soft Tissue Augmentation Around Dental Implants Using Connective Tissue Graft, Submerged Tenting Abutment, or Sub-crestal Implant Placement
| NCT ID | NCT07714265 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Misr International University |
| Condition | Peri-implant Soft Tissue Deficiency |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-07-17 |
| Primary Completion | 2027-07-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2026-07-17 with a primary completion date of 2027-07-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * Adults aged 20 years or older. * Partially edentulous patients requiring a single dental implant in the posterior mandible. * Thin peri-implant soft tissue phenotype (\<2 mm). * Horizontal alveolar ridge width of at least 6 mm. * Vertical bone height of at least 10-12 mm, confirmed radiographically. * Adequate interarch restorative space for implant-supported restoration. * Medically healthy (American Society of Anesthesiologists \[ASA\] Physical Status I or II). * Good oral hygiene. * Able and willing to provide written informed consent. Exclusion Criteria: * Local pathological lesions affecting the surgical site. * Smoking. * Pregnancy or breastfeeding. * Alcohol abuse or parafunctional habits that may compromise implant survival or wound healing. * Medical or local conditions that could interfere with osseointegration, soft tissue healing, or study participation
Contact & Investigator
Hani E elnahass, Phd
STUDY CHAIR
Professor, Department of Oral Medicine and Periodontology, Faculty of Dentistry, Cairo University
Frequently Asked Questions
Who can join the NCT07714265 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, studying Peri-implant Soft Tissue Deficiency. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07714265 currently recruiting?
Yes, NCT07714265 is actively recruiting participants. Contact the research team at baraa2480582@miuegypt.edu.eg for enrollment information.
Where is the NCT07714265 trial being conducted?
This trial is being conducted at Cairo, Egypt.
Who is sponsoring the NCT07714265 clinical trial?
NCT07714265 is sponsored by Misr International University. The principal investigator is Hani E elnahass, Phd at Professor, Department of Oral Medicine and Periodontology, Faculty of Dentistry, Cairo University. The trial plans to enroll 30 participants.