Evaluation of Multilayered PRF in Comparison With Connective Tissue Graft by Sohn Poncho's Technique on Peri-implant Mucosal Enhancement in the Esthetic Zone

NCT07649239 | Recruiting

• 1 other identifier: ZainabMDSperio
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

An effective biological seal is crucial for protecting and supporting dental implants, particularly in the anterior region for the desired esthetic outcome.PRF membrane and CTG has been utilized to improve peri-implant soft tissue thickness and increase the width of keratinized tissue around dental implants. The stability of the PRF membrane is maintained by securing it with the healing abutment of the implant. While a few longitudinal studies have assessed the benefits of using PRF membrane with Sohn's Poncho technique in the posterior region, its effectiveness in the anterior region of the mouth remains to be evaluated.

Conditions

Soft Tissue; Peri-Implant Health; Soft Tissue Augmentation at Dental Implants; Connective Tissue Graft; PRF

Outcome Measures

Primary Outcomes (1)

• Peri-implant soft tissue thickness

  Volumetric

  Time Frame: 6 weeks and 3 and 6 months

Secondary Outcomes (3)

• width of the keratinized tissue around dental implants

  Time Frame: baseline, 3 and 6 months

• Marginal bone loss

  6 months

• Postoperative patient satisfaction VAS 0-5

  baseline, 2 weeks, 6 months

Study Arms (2)

Experimental: Platelet rich fibrin multilayered Platelet-rich fibrin (PRF) is a second-generation au

EXPERIMENTAL

The test group will be treated with dental implant + multilayered PRF membrane. In brief, local anesthesia will be administered, and a crestal incision will be made to access the implant site. A full thickness mucoperiosteal flap will be reflected, exposing the underlying bone. The osteotomy will be performed following the implant manufacturer's guidelines, and a titanium implant will be placed at the planned position. For the purposes of standardization, implants will be placed at subcrestal level in both the groups. In the test group, at 4 months post-implant placement, a small incision will be made to place the healing abutment. Simple interrupted sutures will be used to approximate the tissues.

Procedure: Platelet rich fibrin multilayered Platelet-rich fibrin (PRF) A t the second stage

Active Comparator: Connective Tissue Graft gingival grafting surgery that is done to enhance soft ti

ACTIVE COMPARATOR

The test group will be treated with dental implant + multilayered PRF membrane. In brief, local anesthesia will be administered, and a crestal incision will be made to access the implant site. A full thickness mucoperiosteal flap will be reflected, exposing the underlying bone. The osteotomy will be performed following the implant manufacturer's guidelines, and a titanium implant will be placed at the planned position. For the purposes of standardization, implants will be placed at subcrestal level in both the groups. In the test group, at 4 months post-implant placement, a small incision will be made to place the healing abutment. Simple interrupted sutures will be used to approximate the tissues.

Procedure: Soft tissue augmentation around dental implants with CTG in the second stage

Interventions

Platelet rich fibrin multilayered Platelet-rich fibrin (PRF) A t the second stage PROCEDURE

The test group will be treated with dental implant + multilayered PRF membrane. In brief, local anesthesia will be administered, and a crestal incision will be made to access the implant site. A full thickness mucoperiosteal flap will be reflected, exposing the underlying bone. The osteotomy will be performed following the implant manufacturer's guidelines, and a titanium implant will be placed at the planned position. For the purposes of standardization, implants will be placed at subcrestal level in both the groups. In the test group, at 4 months post-implant placement, a small incision will be made to place the healing abutment. Simple interrupted sutures will be used to approximate the tissues.

Experimental: Platelet rich fibrin multilayered Platelet-rich fibrin (PRF) is a second-generation au

Soft tissue augmentation around dental implants with CTG in the second stage PROCEDURE

The test group will be treated with dental implant and CTG. In brief, local anesthesia will be administered, and a crestal incision will be made to access the implant site. A full thickness mucoperiosteal flap will be reflected, exposing the underlying bone. The osteotomy will be performed following the implant manufacturer's guidelines, and a titanium implant will be placed at the planned position. For the purposes of standardization, implants will be placed at subcrestal level in both the groups. In the test group, at 4 months post-implant placement, a small incision will be made to place the healing abutment. Simple interrupted sutures will be used to approximate the tissues.

Active Comparator: Connective Tissue Graft gingival grafting surgery that is done to enhance soft ti

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Patients with medically compromised conditions like uncontrolled diabetes mellitus or any systemic diseases that may result in compromised hard and soft tissue healing.

Sponsors & Collaborators

• Gulf Medical University: lead

Study Sites (1)

Gulf Medical University

Ajman, Ajman Emirate, 00000, United Arab Emirates

RECRUITING

MeSH Terms

Interventions

Prolactin-Releasing Hormone

Intervention Hierarchy (Ancestors)

Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Nesma MF Shemais

  Assistant professor of Periodontology

  STUDY DIRECTOR

Central Study Contacts

Nesma Shemais, PhD

CONTACT

0529961988; dr.nesma@gmu.ac.ae

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 16, 2026
• Study Start: January 10, 2026
• Primary Completion (Estimated): January 10, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: June 16, 2026

Record last verified: 2026-06

Locations

AE (1)