Assessment of Early Healing Period of Dental Implants

December 29, 2025 updated by: Ezgi Gürbüz, Kutahya Health Sciences University

Assessment of Volumetric Changes During the Early Healing Period of Dental Implant Treatment: Clinical, Radiographic, and Digital Evaluation

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Kütahya, Turkey (Türkiye), 43020
        • Kütahya Health Sciences University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dental implant placement in the posterior mandible
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
Dental implants will be placed in edentulous areas.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Linear and volumetric changes in the tissue
Time Frame: Preoperative and postoperative 2nd, 4th, and 16th months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Keratinized mucosa width (from the edentulous ridge)
Time Frame: Preoperative and postoperative 2nd month
Keratinized tissue measured from the mid-buccal of the edentulous area using a periodontal probe.
Preoperative and postoperative 2nd month
Mucosal thickness (from the edentulous ridge)
Time Frame: Preoperative and postoperative 2nd month
Mucosal thickness measured from the midpoint of the edentulous area using a periodontal probe.
Preoperative and postoperative 2nd month
Mucosal thickness (from the facial aspect of the edentulous ridge)
Time Frame: 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.
Preoperative and postoperative 2nd month
Keratinized mucosa width (from the gingival margin of the dental implant-supported prosthesis)
Time Frame: Postoperative 4th and 16th months
Keratinized tissue measured from the gingival margin of the dental implant-supported prosthesis to the mucogingival junction using a periodontal probe.
Postoperative 4th and 16th months
Mucosal thickness (from 3 mm apical to the gingival margin of the implant-supported prosthesis)
Time Frame: Postoperative 4th and 16th months
Mucosal thickness measured 3 mm apical to the gingival margin of the implant-supported prosthesis using a endodontic spreader.
Postoperative 4th and 16th months
Peri-implant pocket depth
Time Frame: Postoperative 4th and 16th months
Peri-implant pocket depth measured at six points around the dental implant using a periodontal probe.
Postoperative 4th and 16th months
Modified plaque index
Time Frame: Postoperative 4th and 16th months
Modified plaque index measured at four points around the dental implant using a periodontal probe.
Postoperative 4th and 16th months
Modified bleeding index
Time Frame: Postoperative 4th and 16th months
Modified bleeding index measured at four points around the dental implant using a periodontal probe.
Postoperative 4th and 16th months
Marginal bone level
Time Frame: Preoperative and postoperative 2nd, 4th, and 16th months
Marginal bone level measured on periapical radiographs.
Preoperative and postoperative 2nd, 4th, and 16th months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kutahya Health Sciences University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 2, 2024

Primary Completion (Estimated)

March 2, 2026

Study Completion (Estimated)

September 2, 2026

Study Registration Dates

First Submitted

August 12, 2024

First Submitted That Met QC Criteria

August 12, 2024

First Posted (Actual)

August 15, 2024

Study Record Updates

Last Update Posted (Estimated)

January 2, 2026

Last Update Submitted That Met QC Criteria

December 29, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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