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

NCT07727655 | Not Yet Recruiting

• 1 other identifier: MS.26.01.105
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Tooth Loss

Keywords

Immediate dental implant; Enamel matrix derivative; Emdogain; Mandibular molar; Osseointegration

Outcome Measures

Primary Outcomes (1)

• Implant Stability

  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 Outcomes (3)

• Marginal Bone Loss (MBL)

  Immediately postoperatively and 6 months post-implantation

• Modified sulcus bleeding index (mBI)

  3 and 6 months post-implantation

• Bone Density

  Baseline and 6 months post-implantation

Study Arms (2)

Immediate Implant with Enamel Matrix Derivative

EXPERIMENTAL

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); Procedure: Immediate Dental Implant Placement

Immediate Implant without Enamel Matrix Derivative

ACTIVE COMPARATOR

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

Interventions

Enamel Matrix Derivative (Emdogain) BIOLOGICAL

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.

Immediate Implant with Enamel Matrix Derivative

Immediate Dental Implant Placement PROCEDURE

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.

Immediate Implant with Enamel Matrix Derivative; Immediate Implant without Enamel Matrix Derivative

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mansoura University: lead

MeSH Terms

Conditions

Tooth Loss

Interventions

enamel matrix proteins

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Central Study Contacts

Mohamad M Marwa, MSc

CONTACT

+201140990087; mohamad.marwa.1998@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomly assigned to one of two groups: immediate dental implants with enamel matrix derivative (EMD) or without EMD. Each participant receives only one intervention.

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 27, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share