Modified Labial Pedicle Papilla Flap (mLPPF) With or Without De-epithelialized Gingival Graft (dGG) for Peri-implant Papilla Reconstruction

NCT07204353 | Completed

• 1 other identifier: IUCREC.2024.161
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled clinical trial aims to evaluate the effectiveness of two surgical techniques for peri-implant papilla reconstruction in single-tooth implants in the maxillary anterior and premolar regions. A total of 80 cases with papilla deficiency were allocated into three groups: papilla-preserving incisions only (Control), modified labial pedicle papilla flap (mLPPF), and mLPPF combined with a de-epithelialized gingival graft (mLPPF+dGG). Clinical outcomes including papilla fill (Jemt scores), papilla height, and crestal mucosa thickness were assessed at baseline, immediately after surgery, two weeks postoperatively, and six months after final restoration. The primary goal is to determine whether combining connective tissue grafting with flap surgery provides superior and more stable papilla reconstruction compared with papilla preserving flap-only approaches.

Conditions

Peri-Implant Papilla Deficiency

Keywords

Peri-implant papilla reconstruction; Modified labial pedicle papilla flap (mLPPF); De-epithelialized gingival graft (dGG); Crestal mucosa thickness; Jemt papilla index; Dental implant esthetics

Outcome Measures

Primary Outcomes (1)

• Change in Papilla Height

  Papilla height will be measured as the perpendicular distance from the papilla tip to a line connecting the zenith points of the two adjacent teeth, using standardized intraoral photographs and STL-based digital analysis.

  Baseline (T0), İmmediatelly after surgery (T1), 2 weeks postoperatively (T2), and 6 months after final restoration (T3).

Secondary Outcomes (3)

• Change in Jemt Scores

  Baseline (T0), 2 weeks postoperatively (T2), and 6 months after final restoration (T3).

• Change in Crestal Mucosa Thickness

  Baseline (T0), 2 weeks postoperatively (T2), and 6 months after final restoration (T3).

• Correlation Between Papilla Height and Crestal Mucosa Thickness

  Baseline (T0), 2 weeks postoperatively (T2), and 6 months after final restoration (T3).

Study Arms (3)

Control group

ACTIVE COMPARATOR

Papilla-preserving incisions performed during implant uncovering, without additional flap modification or grafting.

Procedure: Papilla-preserving incision (Control)

mLPPF group

EXPERIMENTAL

A modified labial pedicle papilla flap is advanced and sutured to reconstruct the peri-implant papilla, without connective tissue grafting.

Procedure: Modified Labial Pedicle Papilla Flap (mLPPF)

mLPPF+dGG group

EXPERIMENTAL

A modified labial pedicle papilla flap is combined with placement of a de-epithelialized gingival graft harvested from the palate, sutured into the papillary region to enhance papilla reconstruction and increase mucosal thickness.

Procedure: Modified Labial Pedicle Papilla Flap with De-epithelialized Gingival Graft (mLPPF+dGG)

Interventions

Papilla-preserving incision (Control) PROCEDURE

Standard papilla-preserving incision without additional flap modification or connective tissue grafting. This group serves as the control, receiving only routine surgical access for implant site management.

Control group

Modified Labial Pedicle Papilla Flap (mLPPF) PROCEDURE

Surgical reconstruction of the peri-implant papilla using the modified labial pedicle papilla flap technique. The flap is mobilized and sutured without adjunctive grafting procedures.

mLPPF group

Modified Labial Pedicle Papilla Flap with De-epithelialized Gingival Graft (mLPPF+dGG) PROCEDURE

Surgical reconstruction of the peri-implant papilla combining the modified labial pedicle papilla flap with placement of a de-epithelialized gingival graft (dGG) at the papillary region to enhance soft tissue volume and stability.

mLPPF+dGG group

Eligibility Criteria

• Age: 22 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Were between 22 and 45 years of age
• Voluntarily agreed to participate in the study
• Had good periodontal health defined as full-mouth bleeding on probing scores, with \<10%
• Had a single missing tooth in the maxillary anterior or premolar region with both neighbouring teeth present
• Had peri-implant papilla loss defined as JEMT score \<3

You may not qualify if:

• Participants were excluded if they:
• Were smokers
• Had any systemic condition that could potentially influence study outcomes or implant success, such as diabetes mellitus, osteoporosis, or a history of radiotherapy
• Were undergoing pharmacological treatment that could affect the results, including the use of bisphosphonates, immunosuppressive agents, or regular analgesic medications
• Had clinical signs of peri-implant mucositis or peri-implantitis

Sponsors & Collaborators

• Cuneyt Asim Aral: lead

Study Sites (1)

Inonu University Faculty of Dentistry

Malatya, 44210, Turkey (Türkiye)

Location

Related Publications (5)

• Choquet V, Hermans M, Adriaenssens P, Daelemans P, Tarnow DP, Malevez C. Clinical and radiographic evaluation of the papilla level adjacent to single-tooth dental implants. A retrospective study in the maxillary anterior region. J Periodontol. 2001 Oct;72(10):1364-71. doi: 10.1902/jop.2001.72.10.1364.

  PMID: 11699478 BACKGROUND

• Gholami GA, Hariri S, Amid R, Roghanizadeh L, Kadkhodazadeh M, Mehdizadeh A, Youssefi N. Average and Maximum Papilla Heights around Dental Implants in the Anterior Maxillary Region: A Retrospective Clinical Study. Int J Dent. 2022 Feb 11;2022:4235946. doi: 10.1155/2022/4235946. eCollection 2022.

  PMID: 35186085 BACKGROUND

• Tarnow DP, Magner AW, Fletcher P. The effect of the distance from the contact point to the crest of bone on the presence or absence of the interproximal dental papilla. J Periodontol. 1992 Dec;63(12):995-6. doi: 10.1902/jop.1992.63.12.995.

  PMID: 1474471 BACKGROUND

• Botticelli D, Agabiti I, Yamada R, Maniwa N, Apaza Alccayhuaman KA, Nakajima Y. Identifying Key Factors in Papilla Growth Around Implants: Focus on Intraoral Negative Pressure. Dent J (Basel). 2025 Mar 13;13(3):124. doi: 10.3390/dj13030124.

  PMID: 40136752 BACKGROUND

• Beagle JR. Surgical reconstruction of the interdental papilla: case report. Int J Periodontics Restorative Dent. 1992;12(2):145-51.

  PMID: 1521996 BACKGROUND

Study Officials

• Cüneyt A Aral

  Inonu University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors were blinded to group allocation. Papilla height, Jemt scores, and crestal mucosa thickness were measured using standardized intraoral photographs and STL files by independent examiners who were unaware of treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: October 2, 2025
• Study Start: February 1, 2021
• Primary Completion: May 25, 2024
• Study Completion: June 23, 2025
• Last Updated: October 2, 2025

Record last verified: 2025-08

Locations

TU (1)