Evaluation of Enamel Matrix Derivative in Immediate Dental Implants in the Mandibular Molar Region

July 22, 2026 updated by: Mansoura University

Evaluation of Enamel Matrix Derivative in Management of Jumping Gaps Around Immediate Dental Implants in Mandibular Molar Region. A Randomized Clinical Trial

This randomized clinical trial will evaluate the effect of using an enamel matrix derivative during immediate dental implant placement in the mandibular molar region. Patients who require extraction of a non-restorable mandibular molar and immediate implant placement will be randomly assigned to receive an implant placed with enamel matrix derivative or without enamel matrix derivative. Clinical and radiographic outcomes, including implant stability and peri-implant bone changes, will be assessed over a follow-up period of six months. The results of this study aim to determine whether the use of enamel matrix derivative improves osseointegration and healing around immediate dental implants.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Immediate dental implant placement following tooth extraction is a commonly used treatment approach, but achieving predictable osseointegration and preservation of peri-implant bone remains challenging, particularly in the presence of jumping gaps. Enamel matrix derivative is a biologically active material that has been shown to enhance periodontal and bone healing, but its effects around immediate dental implants are not fully established.

This randomized clinical trial will be conducted at the Outpatient Clinic of the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Mansoura University. Twenty-four patients requiring extraction of a single non-restorable mandibular molar will be enrolled and randomly allocated into two equal groups. In the test group, immediate dental implants will be placed with the application of enamel matrix derivative, while in the control group implants will be placed without enamel matrix derivative.

Clinical outcomes will include implant stability measured using resonance frequency analysis and peri-implant soft tissue health assessed by modified sulcus bleeding index. Radiographic outcomes will be evaluated using cone beam computed tomography to assess peri-implant bone dimensional changes, marginal bone loss, and bone density. Assessments will be performed at baseline and during follow-up visits up to six months after implant placement.

Study Type

Interventional

Enrollment (Estimated)

24

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 Contact

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

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients with non-restorable mandibular molar requiring dental extraction.
  2. Patient medically free from systemic diseases that absolutely contraindicate implant surgery.
  3. Age range: from (18 to 45) years.
  4. Adequate inter-arch relation and inter-occlusal space to accommodate the prosthetic restoration (8-12mm).
  5. Extraction sockets with intact bony walls and interradicular bone.
  6. Jumping gap more than 2mm.
  7. Patients with good oral hygiene.
  8. Patients willing to participate in the study's follow-up intervals.

Exclusion Criteria:

  1. Patients with any pathological lesion or aggressive periodontal disease at the planned surgical site impaired the immediate implant placement.
  2. smoker patients.
  3. Pregnant patients.
  4. Patients with para-functional habits (bruxism and clenching)

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immediate Implant with Enamel Matrix Derivative
Participants will receive an immediate dental implant in the mandibular molar region with the application of enamel matrix derivative (EMD) to the extraction socket. Clinical and radiographic outcomes, including implant stability and peri-implant bone changes, will be evaluated over six months.
Biological: Enamel Matrix Derivative (Emdogain)
A single application of enamel matrix derivative (EMD, commercially known as Emdogain) will be applied to the extraction socket during immediate dental implant placement in the mandibular molar region. Clinical and radiographic outcomes, including implant stability and peri-implant bone changes, will be evaluated over six months. The dental implant used is a conventional screw-type titanium implant.
Procedure: Immediate Dental Implant Placement
Participants will receive immediate dental implant placement in the mandibular molar region without enamel matrix derivative. Clinical and radiographic outcomes, including implant stability and peri-implant bone changes, will be evaluated over six months. The dental implant used is a conventional screw-type titanium implant.
Active Comparator: Immediate Implant without Enamel Matrix Derivative
Participants will receive an immediate dental implant in the mandibular molar region without enamel matrix derivative (EMD). Clinical and radiographic outcomes, including implant stability and peri-implant bone changes, will be evaluated over six months.
Procedure: Immediate Dental Implant Placement
Participants will receive immediate dental implant placement in the mandibular molar region without enamel matrix derivative. Clinical and radiographic outcomes, including implant stability and peri-implant bone changes, will be evaluated over six months. The dental implant used is a conventional screw-type titanium implant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant Stability
Time Frame: Baseline (implant insertion), 3 months, and 6 months post-implantation
Implant stability will be assessed using Resonance Frequency Analysis (RFA) with the Osstell ISQ device. Implant stability will be expressed as the Implant Stability Quotient (ISQ), which ranges from 1 to 100. Higher ISQ values indicate greater implant stability.
Baseline (implant insertion), 3 months, and 6 months post-implantation

Secondary Outcome Measures

Outcome Measure
Time Frame
Marginal Bone Loss (MBL)
Time Frame: Immediately postoperatively and 6 months post-implantation
Immediately postoperatively and 6 months post-implantation
Modified sulcus bleeding index (mBI)
Time Frame: 3 and 6 months post-implantation
3 and 6 months post-implantation
Bone Density
Time Frame: Baseline and 6 months post-implantation
Baseline and 6 months post-implantation

Collaborators and Investigators

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

Sponsor

Mansoura University

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 (Estimated)

June 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

July 20, 2026

First Submitted That Met QC Criteria

July 22, 2026

First Posted (Actual)

July 27, 2026

Study Record Updates

Last Update Posted (Actual)

July 27, 2026

Last Update Submitted That Met QC Criteria

July 22, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS.26.01.105

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

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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