Evaluation of Corrective Surgery Versus Dental Implants in Compromised Mandibular Molars

NCT07633834 — Not applicable, Not yet recruiting, 28 participants, Ain Shams University

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Clinical and Radiographic Outcomes of Corrective Surgery Versus Dental Implant Treatment for Management of Compromised Permanent Mandibular Molars (An In-vivo Study)

RegistryNCT07633834
StatusNot yet recruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment28 (Estimated)
SponsorAin Shams University (Other)
ConditionsRoot Caries, Vertical Root Fracture
Interventionshemi sectioning (Procedure)
Datesstart 2027-01-01 (estimated), primary completion 2027-01-01 (estimated), completion 2028-01-01 (estimated), first posted 2026-06-08, last updated 2026-06-08

Related Papers Related Patents Related Grants Related Experts
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-Summary

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.

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+Arms and interventions

ArmTypeInterventionsDescription
HemisectionExperimentalProcedure: hemi sectioningpatients in this group will have hemi sectioning to their compromised mandibular molars
dental implantsNo interventionpatients will undergo extraction and replaced with dental implants
  • hemi sectioning (Procedure): one root will be extracted and the other root will be preserved

+Outcome measures

Primary outcomes

  • • Regulation of clinical signs and symptoms [12 months]: Patient-reported outcomes, including satisfaction, masticatory efficiency, and oral comfort measured by a visual analog scale (VAS).

Secondary outcomes

  • Assessment of radiographic bone changes [12 months]: * Radiographic bone level changes around the retained root or implant. * Detection of any radiographic signs of pathology or treatment failure. Measurements will be recorded in millimeters (mm) using digital radiographic software calibration tools.

+Eligibility

Sex: All, ages: 21 Years to 60 Years, accepts healthy volunteers

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.