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

Clinical, Radiographic, and Digital Evaluation of the Effects of Autogenous Grafts Harvested From Different Palatal Sites and Applied During Second-stage Implant Surgery on the Peri-implant Mucosa

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Peri-implant Mucositis; Peri-implant Health; Free Gingival Graft
• Intervention / Treatment: Procedure: Coronal palatal tissue; Procedure: Apical palatal tissue

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ezgi Gürbüz; Phone Number: +905557411860; Email: ezgi.dogan@ksbu.edu.tr

Study Locations

• Turkey (Türkiye)
  • Merkez
    • Kütahya, Merkez, Turkey (Türkiye), 43100
      • Kütahya Health Sciences University
      • Contact: Ezgi Gürbüz; Phone Number: +905557411860; Email: ezgi.dogan@ksbu.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Coronal palatal tissue; Participants in this group will receive grafts including marginal and interdental palatal gingiva.	Procedure: Coronal palatal tissue; 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.
Active Comparator: Apical palatal tissue; Participants in this group will receive grafts harvested from approximately 1.5 mm apical to the palatal gingival margin.	Procedure: Apical palatal tissue; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Keratinized Mucosa Width	Keratinized tissue width will be measured from the mid-buccal aspect of the edentulous area.	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	Vestibular depth is defined as the vertical distance between the midcrestal area and the point of greatest concavity of the mucosal fold.	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	Modified plaque index will be measured at six points around each implant by an index with a minimum value of 0 and a maximum of 3.	Postoperative 6th month after implant placement and 12th month after prosthetic loading
Modified Bleeding Index	Modified bleeding index will be measured at six points around each implant by an index with a minimum value of 0 and a maximum of 3.	Postoperative 6th month after implant placement and 12th month after prosthetic loading
Peri- implant Probing Depth	Peri-implant probing depth will be measured at six points around each implant.	Postoperative 6th month after implant placement and 12th month after prosthetic loading
Mucosal Recession	Mucosal recession will be measured as the distance between the implant abutment interface and the mucosal margin.	12th month after prosthetic loading
Marginal Bone Level	Marginal bone level will be measured on periapical radiographs taken by the parallel technique.	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)
Pink Esthetic Score (PES)	Peri-implant soft tissue esthetics will be evaluated using the Pink Esthetic Score with a minimum value of 0 and a maximum of 14.	Postoperative 3rd month (second-stage implant surgery) and 12th month after prosthetic loading
Postoperative Pain Assessment	Postoperative pain as patient-reported outcome will be recorded using a visual analog scale (VAS; 0-100).	Postoperative 14 days (daily after graft application)
Analgesic Consumption	The amount of analgesic medication used (mg) will be recorded.	Postoperative 14.days (after graft application)
Patient Satisfaction	Patient satisfaction with the surgical procedure will be assessed using a three-point Likert scale (0 = no, 1 = maybe, 2 = yes).	Postoperative 14.days (after graft application)
Patient-Perceived Esthetic Outcome	Patient perception of peri-implant soft tissue esthetics will be evaluated using a visual analog scale (VAS; 0-100).	12th month after prosthetic loading
Oral Health-Related Quality of Life	Oral health-related quality of life will be assessed using the Oral Health Impact Profile (OHIP-14) questionnaire.	Postoperative 3rd month (second-stage implant surgery) and 12th month after prosthetic loading

Collaborators and Investigators

• Sponsor: Kutahya Health Sciences University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): February 2, 2026
• Primary Completion (Estimated): August 2, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: December 29, 2025
• First Submitted That Met QC Criteria: December 29, 2025
• First Posted (Actual): January 9, 2026

Study Record Updates

• Last Update Posted (Actual): January 9, 2026
• Last Update Submitted That Met QC Criteria: December 29, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: KSBU001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No