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

NCT ID: NCT07204353

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2025-06-23

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.

Detailed Description

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.

Conditions

Peri-Implant Papilla Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control group

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

Group Type: ACTIVE_COMPARATOR

Papilla-preserving incision (Control)

Intervention Type: 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.

mLPPF group

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

Group Type: EXPERIMENTAL

Modified Labial Pedicle Papilla Flap (mLPPF)

Intervention Type: 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+dGG group

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cuneyt Asim Aral

OTHER

Sponsor Role: lead

Responsible Party

Cuneyt Asim Aral

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Cüneyt A Aral

Role: STUDY_CHAIR

Inonu University

Locations

Inonu University Faculty of Dentistry

Malatya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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Reference Type: BACKGROUND

PMID: 11699478 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35186085 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 1474471 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 40136752 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 1521996 (View on PubMed)

Other Identifiers

IUCREC.2024.161

Identifier Type: -

Identifier Source: org_study_id