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Not yet recruiting NCT07727655

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

No phase Interventional Tooth Loss

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Enamel Matrix Derivative (Emdogain), Immediate Dental Implant Placement.
Who it may be relevant to
Registry conditions: Tooth Loss. Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.

Interventions

  • 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.

Primary outcome measures

  • Implant Stability [Time frame: Baseline (implant insertion), 3 months, and 6 months post-implantation]
Secondary outcome measures (3)
  • Marginal Bone Loss (MBL) [Time frame: Immediately postoperatively and 6 months post-implantation]
  • Modified sulcus bleeding index (mBI) [Time frame: 3 and 6 months post-implantation]
  • Bone Density [Time frame: Baseline and 6 months post-implantation]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07727655 · MS.26.01.105

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗