Faculty of Dentistry, Mansoura University - Oral and Maxillofacial Surgery Department
Al Mansurah, Dakahlia Governorate, Egypt
Location status: Recruiting
NCT Number: NCT07727655
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.
Interested in participating?
Request Info18 year–45 year
All sexes
Interventional
Not applicable
Al Mansurah, Dakahlia Governorate, Egypt
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Immediately postoperatively and 6 months post-implantation
Time frame: 3 and 6 months post-implantation
Time frame: Baseline and 6 months post-implantation
Contact information is provided by the study sponsor or research team.
Mansoura University
Other
Evaluation of Enamel Matrix Derivative in Management of Jumping Gaps Around Immediate Dental Implants in Mandibular Molar Region. A Randomized Clinical Trial
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.
Published trials that share one or more normalized conditions with this study.
NCT07812883
Alveolar Ridge Preservation, Alveolar Ridge Resorption After Extraction
Santiago, Santiago Metropolitan, Chile
View Trial DetailsNCT07801573
Alveolar Bone Loss, Bone Diseases
Plovdiv, Bulgaria
View Trial DetailsNCT07280260
Dental Implant, Mouth Diseases
New Orleans, Louisiana, United States
View Trial DetailsNCT06571812
Mouth Diseases, Periodontal Diseases
Columbus, Ohio, United States
View Trial Details