Assessment of Early Healing Period of Dental Implants

NCT06554444 | Active Not Recruiting

• 1 other identifier: 05
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Osseointegration; Biological Width; Dental Implant

Outcome Measures

Primary Outcomes (1)

• Linear and volumetric changes in the tissue

  Linear and volumetric changes in the tissue resulting from the alignment of scan data obtained at four different time points.

  Preoperative and postoperative 2nd, 4th, and 16th months

Secondary Outcomes (9)

• Keratinized mucosa width (from the edentulous ridge)

  Preoperative and postoperative 2nd month

• Keratinized mucosa width (from the gingival margin of the dental implant-supported prosthesis)

  Postoperative 4th and 16th months

• Mucosal thickness (from the edentulous ridge)

  Preoperative and postoperative 2nd month

• Mucosal thickness (from the facial aspect of the edentulous ridge)

  Preoperative and postoperative 2nd month

• Mucosal thickness (from 3 mm apical to the gingival margin of the implant-supported prosthesis)

  Postoperative 4th and 16th months

Study Arms (1)

Dental implant placement in the posterior mandible

EXPERIMENTAL

In this study, patients who have tooth loss in the posterior mandible and meet the inclusion criteria will receive dental implants under local anesthesia

Procedure: Dental Implant Surgery

Interventions

Dental Implant Surgery PROCEDURE

Dental implants will be placed in edentulous areas.

Dental implant placement in the posterior mandible

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kutahya Health Sciences University: lead

Study Sites (1)

Kutahya Health Sciences University

Kütahya, 43020, Turkey (Türkiye)

Location

Related Publications (1)

• Tavelli L, Barootchi S, Vera Rodriguez M, Mancini L, Meneghetti PC, Mendonca G, Wang HL. Early soft tissue changes following implant placement with or without soft tissue augmentation using a xenogeneic cross-link collagen scaffold: A volumetric comparative study. J Esthet Restor Dent. 2022 Jan;34(1):181-187. doi: 10.1111/jerd.12856. Epub 2021 Dec 22.

  PMID: 34936177 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Dental implant placement in the posterior mandible

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: August 15, 2024
• Study Start: September 2, 2024
• Primary Completion: March 2, 2026
• Study Completion (Estimated): September 2, 2026
• Last Updated: January 2, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)