- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07633834
Evaluation of Corrective Surgery Versus Dental Implants in Compromised Mandibular Molars
June 5, 2026 updated by: yomna tarek, Ain Shams University
Clinical and Radiographic Outcomes of Corrective Surgery Versus Dental Implant Treatment for Management of Compromised Permanent Mandibular Molars (An In-vivo Study)
This study seeks to assess the clinical, radiographic, and patient-reported outcomes of hemisection versus implant over a 12 months period, generating robust evidence to guide clinical decision-making and enhance patient care.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
28
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Good oral hygiene and motivation for follow-up care.
- Ability to understand and sign informed consent.
- Localized Root/Periodontal Disease: Severe attachment loss or bone loss (e.g., severe localized periodontitis) affecting the mesial root, while the other root remains healthy.
- Furcation Involvement: Class II or III furcation involvements where the disease cannot be treated by conventional methods.
- Vertical root fracture confined to the mesial root.
- Non-treatable perforation in the mesial root.
- Extensive sub-gingival root caries affecting the mesial root.
- Extensive un-treatable internal and external root resorption related to the mesial root.
Exclusion Criteria:
- Uncontrolled systemic diseases (e.g., diabetes mellitus, bleeding disorders, immunosuppression).
- Fused or poorly shaped roots,
- Active periodontal or endodontic infection at adjacent teeth that may interfere with treatment outcomes.
- Severe bruxism or occlusal parafunction.
- History of radiation therapy in the head and neck region.
- Pregnancy or lactation.
- Poor compliance or inability to attend follow-up visits.
- Smoking more than 10 cigarettes per day.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Hemisection
patients in this group will have hemi sectioning to their compromised mandibular molars
|
one root will be extracted and the other root will be preserved
|
|
No Intervention: dental implants
patients will undergo extraction and replaced with dental implants
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
• Regulation of clinical signs and symptoms
Time Frame: 12 months
|
Patient-reported outcomes, including satisfaction, masticatory efficiency, and oral comfort measured by a visual analog scale (VAS).
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of radiographic bone changes
Time Frame: 12 months
|
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
January 1, 2027
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2028
Study Registration Dates
First Submitted
May 24, 2026
First Submitted That Met QC Criteria
June 5, 2026
First Posted (Actual)
June 8, 2026
Study Record Updates
Last Update Posted (Actual)
June 8, 2026
Last Update Submitted That Met QC Criteria
June 5, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2991994
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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