Assessment of Early Healing Period of Dental Implants

July 22, 2026 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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
        • Kutahya 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 2, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 26, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 2, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 12, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 15, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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