Effectiveness of Connective Tissue Graft With and Without Leukocyte Platelet Rich Fibrin on Peri-implant Soft Tissue Thickness Around Delayed Implants in Patients With Thin Gingival Phenotype: A Randomized Controlled Clinical Trial

A stable soft and hard tissues around Osseo-integrated implants are very crucial. Soft tissue thickness around implants is crucial as it prevents peri-implant bone loss and enhance the esthetic outcomes. The treatment of thin tissue phenotype should be improved as the thin tissue phenotype will lead to plaque accumulation. There are some techniques that can increase the thickness of the peri-implant mucosa including connective tissue graft, platelet- rich fibrin and xenogeneic collagen matrix .Leukocyte and Platelet rich fibrin is a second generation platelet concentrate that was introduced by choukroun et al in 2001 after platelet rich plasma. PRF is the first source of autogenous blood derived growth factors harvested without the use of anticoagulants5. It contains various growth factors that are believed to contribute to periodontal regeneration. It promotes neovascularization and accelerated wound closing

Study Overview

• Status: Recruiting
• Conditions: Soft Tissue Thickness Around Delayed Implants in Patients With Thin Gingival Phenotype
• Intervention / Treatment: Procedure: Connective tissue graft(CTG); Procedure: Connective tissue graft (CTG) + leukocyte platelet-rich fibrin (L-PRF)

Detailed Description

Soft tissue thickness around implants is crucial as it prevents peri-implant bone loss and enhance the esthetic outcomes. The critical amount of soft tissue thickness on the buccal aspect of implants has been determined to be 2mm. Thick mucosal tissue often has better esthetic outcomes as it creates better tissue contour, mask the metal abutment and creating papilla after prosthesis fabrication. The difference in the amount of bone remodeling is related to the difference in mucosal tissue thickness, which is believed to be the result of supracrestal tissue height establishment. Presence of thin gingival phenotype around dental implant increases the prevalence of peri-implantitis and peri-implant mucositis. Thin gingival phenotype and inadequate keratinized mucosa width lead to greater food impaction compared with thick gingival phenotype and adequate keratinized mucosa. Patients with thin gingival phenotype have more pain and discomfort during oral hygiene therefore making it more difficult for plaque control.

Various techniques are used to increase the thickness of the peri-implant mucosa. These include connective tissue grafts, platelet-rich fibrin and xenogeneic collagen matrix. The volume of labial bone may be maintained by the increased thickness of soft tissue as a result of connective tissue graft . The autologous connective tissue graft has been widely recommended for mucosal tissue thickness enhancement due to its favorable thickness with minimal shrinkage in long-term follow-up when compared to other soft tissue graft approaches. Connective tissue graft (CTG) is considered the gold standard for soft-tissue correction and augmentation surgeries, but involves a secondary donor area and its associated complications. Connective tissue graft (CTG) has become a reliable treatment modality for increasing gingival thickness, width of keratinized gingiva, root coverage, treatment of furcation alveolar ridge deficiencies management of peri-implant tissue abnormalities and papillary loss. The scope of free gingival graft has been narrowed down especially in the esthetic region.

Leukocyte and Platelet rich fibrin is a second generation platelet concentrate that was introduced by choukroun et al in 2001 after platelet rich plasma. PRF is the first source of autogenous blood derived growth factors harvested without the use of anticoagulants. It is obtained by a simple and inexpensive procedure that does not require biochemical blood handling. Platelet-rich fibrin (PRF) is increasingly becoming popular in dentistry due to its growth factor-secreting properties and is also known to enhance wound healing and soft tissue thickness at the surgical site.

• Study Type: Interventional
• Enrollment (Estimated): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo Governorate
    • Cairo, Cairo Governorate, Egypt, 11837
      • Recruiting
      • The british university in egypt
      • Contact: Rania Hesham Shalaby, Demonstrator; Phone Number: 01091000217; Email: rania.hesham@bue.edu.eg
      • Principal Investigator: Rania Hesham Shalaby, BDs

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 1. Patients between 18-60 years. 2. With thin gingival phenotype with a peri-implant mucosal thickness of less than 2mm28. With single missing tooth in the incisor, canine and premolar area. With the presence of two natural adjacent teeth and to not have a bone augmentation procedure before or during the dental implant.

  3. Patient consent approval and signing 4. Medically free patients 5. Patients with good oral hygiene 6. Patients free from untreated periodontal disease

Exclusion Criteria:

• 1. Smokers 2. Psychological problem 3. Pregnancy 4. Systemic disease 5. Poor oral hygiene 6. Patients who previously received radiation therapy of the jaws 7. Patients taking medications that affect healing.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control group; Connective tissue graft (CTG)	Procedure: Connective tissue graft(CTG); A harvested connective tissue graft will be placed in the prepared muco-periosteal flap around the implant. The graft will be adapted and secured in place using horizontal matrices.
Active Comparator: Test group; Connective tissue graft (CTG) + leukocyte platelet-rich fibrin (L-PRF)	Procedure: Connective tissue graft (CTG) + leukocyte platelet-rich fibrin (L-PRF); To prepare the L-PRF, a 10 ml of blood will be drawn from the antecubital vein of the patient's right or left arm and will be transferred to the free anticoagulant test-tube. The blood sample will be immediately centrifuged at 2700 rpm for 12 minutes33. L-PRF will be applied over the connective tissue graft in the prepared mucoperiosteal flap around the implant34. Then the graft will be secured with horizontal mattresses with an absorbable vicryl 6-0. A non-absorbable prolene suture will be used to approximate the flap.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gingival thickness	Anesthetic needle with a rubber stopper36 Numerical (mm)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain (direct)	Visual analogue scale.	14 days
Width of keratinized mucosa	Graduated periodontal probe	6 months

Collaborators and Investigators

• Sponsor: British University In Egypt

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: January 20, 2026
• First Submitted That Met QC Criteria: January 20, 2026
• First Posted (Actual): January 26, 2026

Study Record Updates

• Last Update Posted (Actual): January 26, 2026
• Last Update Submitted That Met QC Criteria: January 20, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: CTG; L-Prf; Soft tissue thickness
• Other Study ID Numbers: 23-051

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