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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Soft Tissue Augmentation at Dental Implants; Connective Tissue Graft; Soft Tissue; PRF; Peri-Implant Health
• Intervention / Treatment: Procedure: Platelet rich fibrin multilayered Platelet-rich fibrin (PRF) A t the second stage; Procedure: Soft tissue augmentation around dental implants with CTG in the second stage

Detailed Description

An effective biological seal is crucial for protecting and supporting dental implants, particularly in the anterior region for the desired esthetic outcome.13, 14 Recent studies have shown that the multilayering of the PRF membrane around implants have the same effect on peri-implant mucosal thickness in comparison to the gold standard which is the connective tissue graft without further patient morbidity 13, 14. 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.7, 8 Additionally, the stabilized PRF membrane ensures prolonged exposure of the wound site to bioactive growth factors. Given these advantages, the potential benefits of using PRF membrane with dental implants in the anterior region need further exploration. Thus, this study focuses on comparing multilayering PRF membrane with the gold standard which is the CTG in healing period of 2nd stage implant surgery.

• Study Type: Interventional
• Enrollment (Estimated): 26
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nesma Shemais, PhD; Phone Number: 0529961988; Email: dr.nesma@gmu.ac.ae

Study Locations

• United Arab Emirates
  • Ajman Emirate
    • Ajman, Ajman Emirate, United Arab Emirates, 00000
      • Recruiting
      • Gulf Medical University
      • Contact: Nesma Shemais; Phone Number: 0529961988; Email: dr.nesma@gmu.ac.ae

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

-Inclusion Criteria: Patients with single bounded missing tooth in the esthetic zone Patients in the age group of 21-65 years Patients having good oral hygiene (mean plaque score of < 25%) and with stable periodontal status.

-Exclusion Criteria: Smokers patients Patients with poor maintenance of oral hygiene, as determined by a mean plaque score of ≥ 25% despite efforts by the clinician to improve oral hygiene maintenance.

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: Platelet rich fibrin multilayered Platelet-rich fibrin (PRF) is a second-generation au; 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; 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.
Active Comparator: Active Comparator: Connective Tissue Graft gingival grafting surgery that is done to enhance soft ti; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peri-implant soft tissue thickness	Volumetric	Time Frame: 6 weeks and 3 and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
width of the keratinized tissue around dental implants	Periodontal probe mm	Time Frame: baseline, 3 and 6 months
Marginal bone loss	CBCT measurement	6 months
Postoperative patient satisfaction VAS 0-5	VAS 0-5	baseline, 2 weeks, 6 months

Collaborators and Investigators

• Sponsor: Gulf Medical University
• Investigators: Study Director: Nesma MF Shemais, Assistant professor of Periodontology

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2026
• Primary Completion (Estimated): January 10, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: June 9, 2026
• First Submitted That Met QC Criteria: June 12, 2026
• First Posted (Actual): June 16, 2026

Study Record Updates

• Last Update Posted (Actual): June 16, 2026
• Last Update Submitted That Met QC Criteria: June 12, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Hypothalamic Hormones; Peptide Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins; Prolactin-Releasing Hormone
• Other Study ID Numbers: ZainabMDSperio

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No