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NCT Number: NCT07727655

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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)

Treatment and study plan

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 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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Marginal Bone Loss (MBL)

    Time frame: Immediately postoperatively and 6 months post-implantation

  2. Modified sulcus bleeding index (mBI)

    Time frame: 3 and 6 months post-implantation

  3. Bone Density

    Time frame: Baseline and 6 months post-implantation

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamad M Marwa, MSc

CONTACT

[email protected]

+201140990087

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 27, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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