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

Kutahya Health Sciences University

Status: Not yet enrolling

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

Treatments: Procedure: Coronal palatal tissue; Procedure: Apical palatal tissue

Study type: Interventional

Funder types: Other

Identifiers

NCT07330609

KSBU001

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Coronal palatal tissue

Experimental group

Description:

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

Treatment:

Procedure: Coronal palatal tissue

Apical palatal tissue

Active Comparator group

Description:

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

Treatment:

Procedure: Apical palatal tissue