Gingival Graft vs T-PRF in Papilla Defects

NCT07746622 | Completed

• 1 other identifier: 2023/06
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 2

Brief Summary

Objective: Titanium-prepared platelet-rich fibrin (T-PRF) has emerged as a promising biomaterial in periodontal regenerative procedures. The aim of this study will be to compare the clinical effectiveness of de-epithelialized gingival grafts (DGG) and T-PRF in the reconstruction of deficient interdental papillae using the tunnel technique. Methods: A total of 34 patients presenting with 115 Class I and II interdental papilla defects will be enrolled in this study. Interdental papilla reconstruction will be performed using the tunnel technique in combination with either DGG or T-PRF. Demographic characteristics (age and sex), dentogingival variables (tooth shape, papilla location, jaw type, and papilla loss classification), and clinical parameters will be recorded. Clinical assessments will include probing depth (PD), gingival index (GI), plaque index (PI), gingival thickness (GT), keratinized tissue height (KTH), black triangle width (BTW), black triangle height (BTH), papilla fill percentage (%PF), and black triangle area (BTA). All clinical parameters will be assessed at baseline and at 1, 3, and 6 months following surgery.

Conditions

Papilla Reconstruction

Keywords

De-epithelialized gingival graft; Titanium-prepared Platelet-Rich Fibrin; Han and Takei technique; interdental papilla loss

Outcome Measures

Primary Outcomes (4)

• black triangle height

  The distance between the lowest point of the interdental contact area of teeth adjacent to the papilla and the highest point of the gingival papilla was measured.

  preoperative and postoperative (1, 3, 6 months)

• black triangle width

  The distance between the contact points of the papilla apex and the two adjacent teeth.

  preoperative and postoperative (1, 3, 6 months)

• black triangle area

  BTA was calculated as the area between the interdental contact points of the teeth and the gingival papilla using the formula: BTA= (BTH x BTW) /2

  preoperative and postoperative (1, 3, 6 months)

• % Percentage fill

  The percentage change in black triangle height between two time intervals was calculated using the formula: %PD=(tendBTH - tfirstBTH) /tendBTH x100

  preoperative and postoperative 6 months

Secondary Outcomes (2)

• keratinized tissue height

  preoperative and postoperative (1, 3, 6 months)

• Gingival thickness

  preoperative and postoperative (1, 3, 6 months)

Study Arms (2)

De-epithelialized gingival graft

ACTIVE COMPARATOR

Participants assigned to this group received papilla reconstruction using a de-epithelialized gingival graft harvested from the palatal mucosa. Following tunnel preparation via the tunnel technique, the graft was de-epithelialized to a thickness of approximately 1.5 mm and inserted beneath the papillary flap to fill the defect. Graft stabilization and coronal advancement of the flap were achieved using suspension sutures anchored to preoperatively placed composite splints.

Procedure: De-epithelialized gingival graft

Titanium-prepared Platelet-Rich Fibrin

ACTIVE COMPARATOR

In this group, T-PRF membranes were prepared by centrifuging autologous blood in grade IV titanium tubes at 2,800 rpm for 12 minutes. The resulting fibrin clots were compressed to create standardized membranes, which were folded and placed into the prepared tunnel beneath the papilla. Similar to the DGG group, the flap was coronally repositioned and stabilized using suspension sutures attached to composite splints.

Procedure: Titanium-prepared Platelet-Rich Fibrin

Interventions

De-epithelialized gingival graft PROCEDURE

Papilla reconstruction was performed using the tunnel technique. Sulcular and horizontal incisions on the alveolar mucosa were made with a No. 15c scalpel, extending to the mid-buccal regions of the adjacent teeth. A partial-thickness tunnel flap was prepared using specialized tunneling instruments, with careful preservation of papillary integrity. Additional sulcular incisions were made on the palatal side, and the tunnel was extended beneath the carefully elevated palatal flap. De-epithelialized gingival graft material was inserted from the palatal aspect using a leader suture and guided through the tunnel to exit via the horizontal incision. It was then positioned and stabilized beneath the papillary tissue. Finally, suspension sutures were used to coronally advance the flap, which was secured to preoperatively prepared provisional composite splints to ensure tension-free closure.

De-epithelialized gingival graft

Titanium-prepared Platelet-Rich Fibrin PROCEDURE

Papilla reconstruction was performed using the tunnel technique. Sulcular and horizontal incisions on the alveolar mucosa were made with a No. 15c scalpel, extending to the mid-buccal regions of the adjacent teeth. A partial-thickness tunnel flap was prepared using specialized tunneling instruments, with careful preservation of papillary integrity. Additional sulcular incisions were made on the palatal side, and the tunnel was extended beneath the carefully elevated palatal flap. A Titanium-Prepared Platelet-Rich Fibrin (T-PRF) graft was introduced from the palatal aspect using a leader suture and guided through the tunnel to exit via the horizontal incision. The graft was positioned and stabilized beneath the papillary tissue. Finally, suspension sutures were used to coronally advance the flap, which was secured to preoperatively prepared provisional composite splints to ensure tension-free closure.

Titanium-prepared Platelet-Rich Fibrin

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 25 and 70 years.
• Presence of papilla loss in the anterior region of the maxilla or mandible.
• Classification of papilla loss as Class 1 or 2
• Absence of systemic diseases.
• No bleeding disorders that could interfere with the surgery.
• Non-smoker and non-alcohol consumer.
• Not pregnant or breastfeeding.
• Absence of fillings, prostheses, or root canal treatments in the relevant teeth.
• No prior surgical interventions in the target area.

You may not qualify if:

• Smoking or alcohol consumption.
• Presence of systemic diseases
• Patients who did not attend postoperative follow-up appointments regularly.
• Pregnant or breastfeeding individuals.

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (2)

Pamukkale University Faculty of Dentistry

Denizli, Denizli, 20160, Turkey (Türkiye)

Location

Faculty of Dentistry, Pamukkale University

Denizli, Pamukkale, 20160, Turkey (Türkiye)

Location

Related Publications (1)

• Sharma E, Sharma A, Singh K. The role of subepithelial connective tissue graft for reconstruction of interdental papilla: Clinical study. Singapore Dent J. 2017 Dec;38:27-38. doi: 10.1016/j.sdj.2017.05.001.

  PMID: 29229072 RESULT

Study Officials

• Makbule CAN, Res. asst.

  Pamukkale University Faculty of Dentistry, Denizli, Turkey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research assistant

Study Record Dates

• First Submitted: August 13, 2025
• First Posted: August 5, 2026
• Study Start: November 15, 2022
• Primary Completion: February 14, 2023
• Study Completion: March 14, 2024
• Last Updated: August 5, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)