NCT07633834

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
12mo left

Started Jan 2027

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 8, 2026

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2027

Expected
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

June 8, 2026

Status Verified

May 1, 2026

Enrollment Period

Same day

First QC Date

May 24, 2026

Last Update Submit

June 5, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • • Regulation of clinical signs and symptoms

    Patient-reported outcomes, including satisfaction, masticatory efficiency, and oral comfort measured by a visual analog scale (VAS).

    12 months

Secondary Outcomes (1)

  • Assessment of radiographic bone changes

    12 months

Study Arms (2)

Hemisection

EXPERIMENTAL

patients in this group will have hemi sectioning to their compromised mandibular molars

Procedure: hemi sectioning

dental implants

NO INTERVENTION

patients will undergo extraction and replaced with dental implants

Interventions

one root will be extracted and the other root will be preserved

Hemisection

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Root Caries

Condition Hierarchy (Ancestors)

Dental CariesTooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer at department of Endodontics

Study Record Dates

First Submitted

May 24, 2026

First Posted

June 8, 2026

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2028

Last Updated

June 8, 2026

Record last verified: 2026-05