NCT07608497

Brief Summary

This study seeks to assess the clinical, radiographic, and patient-reported outcomes of root amputation 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 13, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 27, 2026

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2027

Expected
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

May 27, 2026

Status Verified

May 1, 2026

Enrollment Period

5 months

First QC Date

May 13, 2026

Last Update Submit

May 19, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • regression of clinical signs and symptoms and improvement in the bone radiographically

    Disappearance of signs and symptoms including tooth mobility, pain on percussion, functional success. from zero to 10 Visual analgue scale (VAS) will be used to measure the patients pain after the procedure where zero indicated no pain and 10 indicated intorable pain and the bone will be assessed Radiographically. regarding the implant 1ry and 2ndry stability using Any Check and mesiodistal radiographic bone changes.

    12 months

Study Arms (2)

root imputation

EXPERIMENTAL

patients in this group will do root amputation for the defective root in upper maxillary molar

Procedure: root amputation

dental implant

NO INTERVENTION

patients in this group will be directed to extraction and placement of dental implant

Interventions

only one root will be amputated and the rest of the molar will be preserved

root imputation

Eligibility Criteria

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

You may qualify if:

  • Patients will be illegible for root amputation if they one or more of the following criteria:
  • Severe vertical bone loss affecting only Mesio-buccal root of Maxillary molar.
  • Through-and-through furcation involvement
  • Vertical root fracture confined to a Mesio-buccal root of Maxillary molar.
  • Extensive root caries affecting Mesio-buccal root of Maxillary molar.
  • Endodontic failure or non- treatable perforation in Mesio-buccal root of Maxillary molar
  • Extensive internal or external non- treatable root resorption related to Mesio-buccal root of Maxillary molar.
  • Patients who do not meet the above criteria and present with Maxillary molars in more severely compromised conditions will be directed for extraction followed by dental implant placement.

You may not qualify if:

  • \- Uncontrolled systemic disease, immunosuppression, recent bisphosphonate use, head and neck radiotherapy.
  • Patient non-compliance or poor oral hygiene.
  • Heavy smoking or inability to commit to maintenance.
  • Root anatomy or interradicular bone that precludes predictable root amputation; insufficient bone for implant placement that cannot be reasonably augmented.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Root Caries

Interventions

Apicoectomy

Condition Hierarchy (Ancestors)

Dental CariesTooth DemineralizationTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Oral Surgical ProceduresSurgical Procedures, OperativeEndodonticsDentistry

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

Study Record Dates

First Submitted

May 13, 2026

First Posted

May 27, 2026

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

January 1, 2028

Last Updated

May 27, 2026

Record last verified: 2026-05