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

N/ANot Yet RecruitingNCT07330609

Kutahya Health Sciences University30 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Peri-implant Health Free Gingival Graft Peri-implant Mucositis

Interventions

Eligibility

Sex: ALLMin age: 18 Months

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

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 Outcomes

Keratinized Mucosa Width

Keratinized tissue width will be measured from the mid-buccal aspect of the edentulous area.

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

Vestibular depth is defined as the vertical distance between the midcrestal area and the point of greatest concavity of the mucosal fold.

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

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 12th month after prosthetic loading

Marginal Bone Level

Marginal bone level will be measured on periapical radiographs taken by the parallel technique.

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)

Peri-implant soft tissue esthetics will be evaluated using the Pink Esthetic Score with a minimum value of 0 and a maximum of 14.

Time frame: 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).

Time frame: Postoperative 14 days (daily after graft application)

Analgesic Consumption

The amount of analgesic medication used (mg) will be recorded.

Time frame: 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).

Time frame: 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).

Time frame: 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.

Time frame: Postoperative 3rd month (second-stage implant surgery) and 12th month after prosthetic loading

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts