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

ConditionTooth Loss
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorMansoura University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Enamel Matrix Derivative (Emdogain)

    Biological/Vaccine

    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/Surgery

    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.

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Immediate Implant with Enamel Matrix DerivativeExperimental treatment 2 interventions
Group B: Immediate Implant without Enamel Matrix DerivativeActive comparator 1 intervention

Trial outcomes

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.

Time frame
Baseline (implant insertion), 3 months, and 6 months post-implantation

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mansoura University

Lead sponsor

Source ClinicalTrials.gov
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