Skip to main content
OpenTrials
Completed

NCT Number: NCT07204353

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

22 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Inonu University Faculty of Dentistry

Malatya, 44210, Turkey (Türkiye)

About this study

Peri-implant papilla deficiency remains one of the most challenging aspects of achieving esthetic success in implant dentistry, particularly in the anterior maxilla where soft tissue harmony plays a pivotal role. Despite the development of several surgical and prosthetic techniques, no universally accepted gold standard procedure or biomaterial has been established for papilla reconstruction.

This randomized controlled clinical trial was designed to investigate the clinical outcomes of two surgical approaches for peri-implant papilla reconstruction: the modified labial pedicle papilla flap (mLPPF) performed alone, and mLPPF combined with a de-epithelialized gingival graft (mLPPF+dGG). Patients presenting with single-tooth missing sites in the maxillary anterior or premolar regions, associated with papilla loss, were recruited. A total of 80 cases were allocated to three groups:

Control group - papilla-preserving incisions only,

mLPPF group - surgical papilla reconstruction with a modified pedicle flap,

mLPPF+dGG group - flap reconstruction combined with a connective tissue graft harvested and de-epithelialized from the palate.

Clinical outcomes included Jemt papilla index scores, papilla height (measured using standardized intraoral photography and STL files), and crestal mucosa thickness. Measurements were obtained at baseline (T0), immediately after surgery (T1), two weeks postoperatively (T2), and six months after prosthetic restoration (T3).

The primary hypothesis was that combining flap techniques with dGG would result in superior papilla fill and long-term tissue stability compared with flap-only or incision-only techniques. Statistical analyses confirmed that the mLPPF+dGG group demonstrated significantly higher Jemt scores, papilla height, and crestal mucosa thickness from the early postoperative period through the six-month follow-up. Moreover, strong positive correlations were identified between papilla height and crestal mucosa thickness, supporting the biological interplay between vertical mucosal thickness and papillary stability.

The trial provides randomized controlled evidence that the use of de-epithelialized gingival grafts in combination with pedicle flap surgery is a predictable and effective method for peri-implant papilla reconstruction, with potential implications for clinical practice in esthetically demanding cases.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants were eligible for inclusion if they:
  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Change in Papilla Height

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

    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.

Secondary outcomes

  1. Change in Jemt Scores

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

    Jemt scores will be assessed based on the degree of papilla fill, ranging from 0 (no papilla) to 4 (hypertrophic papilla).

  2. Change in Crestal Mucosa Thickness

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

    Crestal mucosa thickness will be measured at the mid-buccal aspect using a standardized endodontic reamer with silicone stopper under local anesthesia. Measurements will be confirmed through STL-based analysis.

  3. Correlation Between Papilla Height and Crestal Mucosa Thickness

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

    The relationship between papilla height and crestal mucosa thickness will be analyzed to determine the impact of vertical soft tissue thickness on papilla stability.

Sponsors and collaborators

Lead sponsor

Cuneyt Asim Aral

Other

Registry information

Official study title

A Novel Surgical Procedure for Peri-implant Papilla Reconstruction in the Aesthetic Region: Modified Labial Pedicle Papilla Flap Technique With De-epithelialized Gingival Graft

Acronym: mLPPF-dGG

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Oct 2, 2025
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.