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

Official title

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

Overview

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.

Interventions

• 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.
• 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.

Primary outcome measures

• Peri-implant Mucosal Thickness [Time frame: 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 (12)

• Keratinized Mucosa Width [Time frame: 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 [Time frame: 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 [Time frame: Postoperative 6th month after implant placement and 12th month after prosthetic loading]
• Modified Bleeding Index [Time frame: Postoperative 6th month after implant placement and 12th month after prosthetic loading]
• Peri- implant Probing Depth [Time frame: Postoperative 6th month after implant placement and 12th month after prosthetic loading]
• Mucosal Recession [Time frame: 12th month after prosthetic loading]
• Marginal Bone Level [Time frame: 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) [Time frame: Postoperative 3rd month (second-stage implant surgery) and 12th month after prosthetic loading]
• Postoperative Pain Assessment [Time frame: Postoperative 14 days (daily after graft application)]
• Analgesic Consumption [Time frame: Postoperative 14.days (after graft application)]
• Patient Satisfaction [Time frame: Postoperative 14.days (after graft application)]
• Patient-Perceived Esthetic Outcome [Time frame: 12th month after prosthetic loading]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Kutahya Health Sciences University — Kütahya

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. PMID 18266873
• 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

Identifiers

NCT: NCT07330609 · KSBU001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗