Assessment of Early Healing Period of Dental Implants

Not Applicable

• Conditions: Biological Width; Dental Implant; Osseointegration
• Interventions: Procedure: Dental Implant Surgery

• Registration Number: NCT06554444
• Lead Sponsor: Kutahya Health Sciences University

Brief Summary

This prospective cohort study aimed to evaluate, clinically, radiographically, and digitally, the volumetric changes occurring during the early healing period after implant treatment in patients with tooth loss in the posterior regions of the jaws, focusing on the processes of osseointegration and biological width formation.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-12
• Study First Submitted QC: 2024-08-12
• Study First Posted: 2024-08-15
• Study Start: 2024-09-02
• Last Update Submitted: 2025-01-06
• Last Update Posted: 2025-01-08
• Primary Completion: 2026-03-02
• Study Completion: 2026-09-02

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Over the age of 18
• Systemically healthy
• Need for implant treatment in unilaterally edentulous posterior mandible
• Sufficient interocclusal space for implant and restoration placement
• At least four months passed since tooth extraction
• Alveolar bone height adequate for implant placement, with a minimum width of 6 mm, and without risking anatomical structures
• Plaque and bleeding scores of less than 15% in the entire mouth
• Presence of opposing teeth in occlusion
• Written informed consent obtained, including 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
• Patients with suppressed immune systems
• History of radiotherapy to the head and neck region
• Diseases or medications affecting bone metabolism
• Smoking more than 10 cigarettes per day
• Bone augmentation performed before or concurrently with the implant
• Failure to achieve primary stability with the implant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dental implant placement in the posterior mandible	Dental Implant Surgery	In this study, patients who have tooth loss in the posterior mandible and meet the inclusion criteria will receive dental implants under local anesthesia

Primary Outcome Measures

Name	Time	Method
Linear changes in the tissue	Preoperative and postoperative 2nd, 4th, and 12th months	Linear changes in the tissue resulting from the alignment of scan data obtained at four different time points.

Secondary Outcome Measures

Name	Time	Method
Mucosal thickness (from the edentulous ridge)	Preoperative and postoperative 2nd month	Mucosal thickness measured from the midpoint of the edentulous area using a periodontal probe.
Keratinized mucosa width (from the edentulous ridge)	Preoperative and postoperative 2nd month	Keratinized tissue measured from the mid-buccal of the edentulous area using a periodontal probe.
Peri-implant pocket depth	Postoperative 4th and 12th months	Peri-implant pocket depth measured at six points around the dental implant using a periodontal probe.
Modified bleeding index	Postoperative 4th and 12th months	Modified bleeding index measured at four points around the dental implant using a periodontal probe.
Marginal bone level	Preoperative and postoperative 2nd, 4th, and 12th months	Marginal bone level measured on periapical radiographs.
Mucosal thickness (from the facial aspect of the edentulous ridge)	Preoperative and postoperative 2nd month	Mucosal thickness measured at the mid-buccal of the edentulous area, from the midpoint between the mucogingival junction and 2 mm apical to the gingival margin of the adjacent tooth, using a endodontic spreader.
Mucosal thickness (from 3 mm apical to the gingival margin of the implant-supported prosthesis)	Postoperative 4th and 12th months	Mucosal thickness measured 3 mm apical to the gingival margin of the implant-supported prosthesis using a endodontic spreader.
Modified plaque index	Postoperative 4th and 12th months	Modified plaque index measured at four points around the dental implant using a periodontal probe.
Keratinized mucosa width (from the gingival margin of the dental implant-supported prosthesis)	Postoperative 4th and 12th months	Keratinized tissue measured from the gingival margin of the dental implant-supported prosthesis to the mucogingival junction using a periodontal probe.

Trial Locations

Locations (1)

Kutahya Health Sciences University; 🇹🇷 Kutahya, Turkey