An interventional study of Enamel Matrix Derivative (Emdogain) and Immediate Dental Implant Placement in Tooth Loss, sponsored by Mansoura University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Mansoura University · Not applicable, Interventional, and Treatment
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.
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.
165 studies on the registry are indexed under Tooth Loss; 44 are open to participants now.
This study's planned enrollment of 24 is below the median of 30 across 120 interventional studies indexed under Tooth Loss.
Browse Tooth Loss studies →Mansoura University is the lead sponsor of 1,119 studies on the registry; 183 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
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
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
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.
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.
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
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
Plan to share: No
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Studies of the drug tested here: Enamel matrix proteins