Strip Graft w/ Xenogeneic Matrix vs Free Gingival Graft for the Augmentation of Peri-implant Keratinized Mucosa

NCT06261268 | Active Not Recruiting

• 1 other identifier: Strip vs FGG
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to compare changes in peri-implant keratinized mucosa (PIKM) following the application of apically repositioned flap (ARF) using a combination of a Strip graft and a Xenogeneic matrix, or with a free gingival graft (FGG), in implants in the second stage with \<2 mm of PIKM. Additionally, as a secondary objective, the investigators compare postoperative blood supply in both recipient and donor sites based on the type of graft obtained. Meanwhile, the investigators evaluate differences between the two groups concerning microcirculation values (perfusion units, PU), soft tissue thickness (STT), volume change, vestibular depth, as well as clinical, aesthetic, and patient-reported outcome measures (PROMS).

Conditions

Peri-Implantational Loss; Surgical Wound; Healing Surgical Wounds; Thin-gingiva

Keywords

Strip graft; Free gingival graft; Peri-implant keratinized mucosa; Soft tissue augmentation; Early wound healing; Postoperative blood supply

Outcome Measures

Primary Outcomes (1)

• Changes in peri-implant keratinized mucosa width (mm)

  the apico-coronal linear dimension of the buccal peri-implant keratinized mucosa (PIKM) will be measured with a UNC15 periodontal probe (Hu-Friedy manufacturing, Co., LLC, Chicago, USA) as the linear dimension of the buccal vestibule, from the buccal peri-implant mucosa margin to the mucogingival junction at the mid-buccal aspect of the treated implant and adjacent mesial tooth.

  Baseline, 1, 3, 6 and 12 months

Secondary Outcomes (15)

• Vascularization (in Laser Speckle perfusion units [LSPU])

  pre-surgically, post-surgically at 4, 7, 10, 14 and 30 days, and at 3-6 and 12 months

• Changes in soft tissue thickness (STT) (mm)

  Baseline, post-op, 1, 3, 6 and 12 months

• Vestibule depth (VD) (mm)

  Pre-surgically, and at 30 days, 3-6 and 12 months

• Probing pocket depth (PPD) (mm)

  pre-surgically, at 3, 6 and 12 months after surgery

• Dehiscence (mm)

  post-surgically, at 3, 6 and 12 months after surgery

Study Arms (2)

Strip graft with Mucograft

EXPERIMENTAL

An apically repositioned flap is prepared then, a free epithelialized gingival strip graft is harvested from the molar area of the palate and sutured to the apical part of the recipient area. A xenogeneic collagen matrix (Mucograft®. Geistlich Pharma AG, Wolhusen, Switzerland) covers the remaining uncovered part of the periosteal bed.

Procedure: Strip graft with Mucograft

Free gingival graft

ACTIVE COMPARATOR

Apically repositioned flap is prepared. An epithelialized free gingival graft is harvested from the molar area of the palate, and sutured to the recipient area

Procedure: Free gingival graft

Interventions

Strip graft with Mucograft PROCEDURE

An apically repositioned flap is made in the vestibular region. The flap is then elevated with a split-thickness preparation, and the mucogingival junction will be repositioned apically and fixed with periosteal-anchored sutures. Then, a free epithelialized gingival strip graft will be harvested from the molar area of the palate. The "Strip" graft is sutured to the apical end of the recipient bed. The remaining uncovered part of the periosteal bed will be covered with a xenogeneic collagen matrix (Mucograft®. Geistlich Pharma AG, Wolhusen, Switzerland) fixed with simple interrupted and crossed sutures. The edges of the palatal wound (donor area) will be approximated with crossed sutures.

Strip graft with Mucograft

Free gingival graft PROCEDURE

The preparation of the apically repositioned flap and the recipient bed with its apico-coronal design and dimension is performed as in the test group. Subsequently, an epithelialized free gingival graft with the size of the entire recipient area with a thickness of 2 mm will be harvested from the molar area of the palate. The graft is sutured to the recipient periosteal bed using simple interrupted and crossed sutures. In the donor area, a collagen sponge is sutured to the wound by means of crossed sutures.

Free gingival graft

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients older than 18 years
• Short-span dental implants in the mandible at second stage with inadequate PIKM (\<2 mm) with at least one adjacent tooth mesially
• Periodontally healthy patients with a pristine or reduced periodontium
• Plaque index (FMPS) less than 20%.

You may not qualify if:

• Compromised general health status that contraindicates study procedures (≥ASA III);
• Drug or alcohol abuse;
• Smoking of \> 10 cigarettes per day;
• Chronic use of corticosteroids, NSAIDs or immunomodulators (any type or dose);
• Pregnant or lactating women;
• History of previous mucogingival surgeries in the area of interest

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Study Sites (1)

Complutense University

Madrid, Madrid, 28040, Spain

Location

Related Publications (6)

• Ramanauskaite A, Schwarz F, Sader R. Influence of width of keratinized tissue on the prevalence of peri-implant diseases: A systematic review and meta-analysis. Clin Oral Implants Res. 2022 Jun;33 Suppl 23:8-31. doi: 10.1111/clr.13766.

  PMID: 35763022 BACKGROUND

• Sanz M, Schwarz F, Herrera D, McClain P, Figuero E, Molina A, Monje A, Montero E, Pascual A, Ramanauskaite A, Renouard F, Sader R, Schiegnitz E, Urban I, Heitz-Mayfield L. Importance of keratinized mucosa around dental implants: Consensus report of group 1 of the DGI/SEPA/Osteology Workshop. Clin Oral Implants Res. 2022 Jun;33 Suppl 23:47-55. doi: 10.1111/clr.13956.

  PMID: 35763021 BACKGROUND

• Montero E, Molina A, Matesanz P, Monje A, Sanz-Sanchez I, Herrera D. Efficacy of soft tissue substitutes, in comparison with autogenous grafts, in surgical procedures aiming to increase the peri-implant keratinized mucosa: A systematic review. Clin Oral Implants Res. 2022 Jun;33 Suppl 23:32-46. doi: 10.1111/clr.13751.

  PMID: 35763018 BACKGROUND

• Solonko M, Regidor E, Ortiz-Vigon A, Montero E, Vilchez B, Sanz M. Efficacy of keratinized mucosal augmentation with a collagen matrix concomitant to the surgical treatment of peri-implantitis: A dual-center randomized clinical trial. Clin Oral Implants Res. 2022 Jan;33(1):105-119. doi: 10.1111/clr.13870. Epub 2021 Oct 21.

  PMID: 34651349 BACKGROUND

• Urban IA, Lozada JL, Nagy K, Sanz M. Treatment of severe mucogingival defects with a combination of strip gingival grafts and a xenogeneic collagen matrix: a prospective case series study. Int J Periodontics Restorative Dent. 2015 May-Jun;35(3):345-53. doi: 10.11607/prd.2287.

  PMID: 25909521 BACKGROUND

• Molnar E, Molnar B, Lohinai Z, Toth Z, Benyo Z, Hricisak L, Windisch P, Vag J. Evaluation of Laser Speckle Contrast Imaging for the Assessment of Oral Mucosal Blood Flow following Periodontal Plastic Surgery: An Exploratory Study. Biomed Res Int. 2017;2017:4042902. doi: 10.1155/2017/4042902. Epub 2017 Jan 23.

  PMID: 28232940 BACKGROUND

Related Links

• Institutional homepage

MeSH Terms

Conditions

Surgical Wound

Interventions

Mucograft

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Mariano Sanz Alonso

  Universidad Complutense de Madrid

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized controlled equivalence clinical trial will be performed, with two parallel groups, a 1:1 allocation ratio, and a 12-month follow-up.

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: February 15, 2024
• Study Start: January 29, 2024
• Primary Completion (Estimated): April 9, 2027
• Study Completion (Estimated): April 9, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)