Evaluation of Corrective Surgery Versus Dental Implants in Compromised Upper Molars

N/ANot Yet RecruitingNCT07608497

Ain Shams University28 enrolled

Overview

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.

This trial aims to compare periodontal stability, functional outcomes, complications, and patient-reported satisfaction of root amputation versus extraction followed by implant-supported single-tooth restoration. Twenty- eight patients (14 per arm) aged 20-50 with Maxillary first or second molars exhibiting Grade II-III furcation, adequate adjacent bone, and good oral hygiene will be enrolled; exclusions include uncontrolled systemic disease, heavy smoking. Participants will be randomized 1:1 Group A will receive endodontic therapy as indicated, surgical root amputation, while Group B will undergo extraction, and implant placement per standard protocols, and implant crowns. The primary outcome is survival at 12 months; secondary outcomes , clinical attachment level, radiographic bone level, peri-implant/peri-root and prosthetic complications, masticatory function, with clinical and standardized radiographic assessments at 1,3, 6 and 12 months. Data will be statistically analyzed using appropriate tests with significance set at p ≤ 0.05.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Root Caries

Interventions

root amputationPROCEDURE

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

Eligibility

Sex: ALLMin age: 21 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * \- 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.

Outcomes

Primary Outcomes

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.

Time frame: 12 months

Data from ClinicalTrials.gov

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