MedTrace Logo

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

NCT07204353 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-10-02

No results posted yet for this study

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

Interventions

PROCEDURE

Papilla-preserving incision (Control)

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.

PROCEDURE

Modified Labial Pedicle Papilla Flap (mLPPF)

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.

PROCEDURE

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

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.

Sponsors & Collaborators

  • Cuneyt Asim Aral

    lead OTHER

Principal Investigators

  • Cüneyt A Aral · Inonu University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2024-05-25
Completion
2025-06-23

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07204353 on ClinicalTrials.gov