Clinical, Radiographic, and Digital Evaluation of the Effects of Autogenous Grafts on Peri-implant Mucosa

NCT07330609 | Not Yet Recruiting

• 1 other identifier: KSBU001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effects of autogenous grafts harvested from different palatal regions on the peri-implant mucosa when applied during second-stage dental implant surgery. Clinical, radiographic, and digital assessment methods will be used to investigate the early effects of these grafts on peri-implant mucosal width and thickness. In addition, peri-implant tissue health and patient-reported outcomes will be evaluated to compare the effectiveness of the grafting techniques in peri-implant soft tissue management.

Conditions

Peri-implant Health; Free Gingival Graft; Peri-implant Mucositis

Outcome Measures

Primary Outcomes (1)

• Peri-implant Mucosal Thickness

  The primary outcome is the change in peri-implant mucosal thickness measured at four time points using clinical and digital methods.

  Pre-operative and post-operative (before implant placement, 3rd month (second-stage implant surgery), 6th month after implant placement, and 12th month after prosthetic loading)

Secondary Outcomes (13)

• Keratinized Mucosa Width

  Pre-operative and post-operative (before implant placement, 3rd month (second-stage implant surgery), 6th month after implant placement, and 12th month after prosthetic loading)

• Vestibular Depth

  Pre-operative and post-operative (before implant placement, 3rd month (second-stage implant surgery), 6th month after implant placement, and 12th month after prosthetic loading)

• Modified Plaque Index

  Postoperative 6th month after implant placement and 12th month after prosthetic loading

• Modified Bleeding Index

  Postoperative 6th month after implant placement and 12th month after prosthetic loading

• Peri- implant Probing Depth

  Postoperative 6th month after implant placement and 12th month after prosthetic loading

Study Arms (2)

Coronal palatal tissue

EXPERIMENTAL

Participants in this group will receive grafts including marginal and interdental palatal gingiva.

Procedure: Coronal palatal tissue

Apical palatal tissue

ACTIVE COMPARATOR

Participants in this group will receive grafts harvested from approximately 1.5 mm apical to the palatal gingival margin.

Procedure: Apical palatal tissue

Interventions

Coronal palatal tissue PROCEDURE

This group will receive palatal grafts including marginal and interdental gingiva. This coronal palatal tissue will be applied to the peri-implant tissue at the second-stage implant surgery.

Coronal palatal tissue

Apical palatal tissue PROCEDURE

This group will receive palatal grafts harvested from approximately 1.5 mm apical to the gingival margin. This graft will be applied to the peri-implant tissue at the second-stage implant surgery.

Apical palatal tissue

Eligibility Criteria

• Age: 18 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age over 18 years
• Systemically healthy patients
• Presence of premolar or molar tooth loss in the mandible
• Adequate mesiodistal and interocclusal space for implant and restoration placement
• At least four months elapsed since tooth extraction
• Alveolar bone width of at least 6 mm and sufficient alveolar bone height to allow implant placement without compromising anatomical structures
• Full-mouth plaque and bleeding scores less than 20%
• Presence of opposing teeth in occlusion
• Keratinized mucosa width in the relevant region less than 2 mm
• Keratinized mucosa thickness in the relevant region of 2 mm or less
• Presence of a healthy second premolar in the maxilla
• Provision of written informed consent and permission for the use of data for research purposes

You may not qualify if:

• Poor oral hygiene
• Uncontrolled periodontal disease
• Pregnancy or lactation at any stage of the study
• Uncontrolled diabetes mellitus
• Immunocompromised patients
• Previous radiotherapy to the head and neck region
• Diseases or medications affecting bone metabolism
• Antibiotic use within the three months prior to the procedure
• Smoking more than 10 cigarettes per day
• Pre- or simultaneous bone augmentation prior to implant placement
• Lack of primary stability at the time of implant placement

Sponsors & Collaborators

• Kutahya Health Sciences University: lead

Study Sites (1)

Kutahya Health Sciences University

Kütahya, Merkez, 43100, Turkey (Türkiye)

Location

Related Publications (2)

• Zigdon H, Machtei EE. The dimensions of keratinized mucosa around implants affect clinical and immunological parameters. Clin Oral Implants Res. 2008 Apr;19(4):387-92. doi: 10.1111/j.1600-0501.2007.01492.x. Epub 2008 Feb 11.

  PMID: 18266873 BACKGROUND

• Bassetti RG, Stahli A, Bassetti MA, Sculean A. Soft tissue augmentation procedures at second-stage surgery: a systematic review. Clin Oral Investig. 2016 Sep;20(7):1369-87. doi: 10.1007/s00784-016-1815-2. Epub 2016 Apr 4.

  PMID: 27041111 BACKGROUND

Central Study Contacts

Ezgi Gürbüz

CONTACT

+905557411860; ezgi.dogan@ksbu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Single blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized controlled clinical trial with parallel groups

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: January 9, 2026
• Study Start: February 2, 2026
• Primary Completion (Estimated): August 2, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: January 9, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)