Tooth LossNCT07727655
Evaluation of Enamel Matrix Derivative in Immediate Dental Implants in the Mandibular Molar Region
A study testing Enamel Matrix Derivative (Emdogain) and Immediate Dental Implant Placement in people with Tooth Loss, run by Mansoura University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Tooth Loss
- What is being tested?
- Enamel Matrix Derivative (Emdogain) and Immediate Dental Implant Placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Sep 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Mansoura University - Oral and Maxillofacial Surgery Department
Al Mansurah, Dakahlia Governorate
About this study
Official title: Evaluation of Enamel Matrix Derivative in Management of Jumping Gaps Around Immediate Dental Implants in Mandibular Molar Region. A Randomized Clinical 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.
Read the 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.
- Conditions
- Tooth Loss
- Being tested
- Enamel Matrix Derivative (Emdogain), Immediate Dental Implant Placement
- Keywords
- Immediate dental implant, Enamel matrix derivative, Emdogain, Mandibular molar, Osseointegration
- Medical subject headings
- Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 PlacementProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Immediate Dental Implant Placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (implant insertion), 3 months, and 6 months post-implantation
Secondary outcomes (3)
Marginal Bone Loss (MBL)
Measured: Immediately postoperatively and 6 months post-implantation
Modified sulcus bleeding index (mBI)
Measured: 3 and 6 months post-implantation
Bone Density
Measured: Baseline and 6 months post-implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start11 Sep 2026
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth LossStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07727655
- Sponsor's protocol ID
- MS.26.01.105
- Status last verified
- Sep 2026
- First submitted
- 20 Jul 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Enamel Matrix Derivative in Management of Jumping Gaps Around Immediate Dental Implants in Mandibular Molar Region. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07727655
- Acronym / sponsor ID
- MS.26.01.105
- Conditions
- Tooth Loss
- Keywords
- Immediate dental implant, Enamel matrix derivative, Emdogain, Mandibular molar, Osseointegration
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 11 Sep 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 27 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Immediate Implant with Enamel Matrix Derivative | Experimental | Biological: Enamel Matrix Derivative (Emdogain), Procedure: Immediate Dental Implant PlacementParticipants 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. |
| Immediate Implant without Enamel Matrix Derivative | Active comparator | Procedure: Immediate Dental Implant PlacementParticipants 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Biological | Immediate Implant with Enamel Matrix Derivative |
| Immediate Dental Implant PlacementParticipants 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. | Procedure or surgery | Immediate Implant with Enamel Matrix Derivative, Immediate Implant without Enamel Matrix Derivative |
Primary outcome
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enamel Matrix Derivative (Emdogain) and Immediate Dental Implant Placement in people with Tooth Loss, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamad M Marwa, MSc (+201140990087, mohamad.marwa.1998@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant Stability (time frame: Baseline (implant insertion), 3 months, and 6 months post-implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.