Comparison of Surgical Extrusion vs. Fibre Post Restoration for Crown-root Fractured Maxillary Incisors.

Not Applicable

• Conditions: Fractured Tooth
• Interventions: Device: Fibre post; Procedure: Surgical extrusion

• Registration Number: NCT04685161
• Lead Sponsor: Tamil Nadu Dr.M.G.R.Medical University

Brief Summary

A total of 124 samples was calculated to be sufficient with G\*power software ver 3.1.9.2 with effect size of 0.4 alpha probability error and power 0.95.With drop out estimate of 10% the final sample size decided was 140 samples. Patients reporting with complicated(pulp exposed or pulpally involved) horizontal crown root fracture with loss of crown structure in maxillary incisors and radiograph evidence of supra alveolar tooth structure are recruited for study. Informed consent from the patients or guardian as appropriate is obtained as suitable prior to treatment delivery. Exclusion criteria were:patients not willing for recall visits, root with evidence of cervical resorption or roor canal filling, open apices, patient with systemic ailments rendering root canal treatment, compromised periodontal health, vertical or horizontal root fracture. Pulpal condition of tooth was assessed using cold sensibility test(Neosnow, orikam health care Ltd, India.) amd confirmed upon access opening with teeth showing evidence of pulpal bleeding wad categorized as irreversible pulpitis and teeth with no evidence of pulpal bleeding categorized as necrotic pulp.

Detailed Description

Patients are randomly alloted to treatment groups. Group I-Root canal treatment followed by surgical extrusion of teeth till about 40%supra gingival crown structure is visible clinically.

Group II-Root canal treatment followed by glass fibre post placement (Reforpost, Angelus, Brazil) and composite (charisma smart, Germany) core build up with porcelain fused metal crown.

Post treatment visits are scheduled 6,12,18 months, scheduled visits were planned as close as possible to the study protocol, but for the purpose of data collection, any recall visit occuring within plus or minus 10% of the advocated time was considered aa occuring at that time. Recall visit check up included clinical examination for mobility, periapical tenderness, gingival pocket depth estimation,bleeding on probing and radiographic examination. Patients are asked to report immediately of any unforeseen circumstances arises in the restored teeth.

Study Timeline

• Study First Submitted: 2020-12-16
• Study First Submitted QC: 2020-12-24
• Study First Posted: 2020-12-28
• Study Start: 2021-01-15
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-29
• Last Update Posted: 2021-03-30
• Primary Completion: 2022-05
• Study Completion: 2023-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• patients with complicated crown root fracture
• patients willing for recall
• Good oral hygiene

Exclusion Criteria

• patients not willing for recall
• Patients health rendering root canal treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fibre post	Fibre post	Treatment modality normally used for crown-root fractured tooth
Surgical extrusion	Surgical extrusion	Novel and alternative treatment option for horizontal crown root fractured maxillary incisors

Primary Outcome Measures

Name	Time	Method
Radiographic healing of teeth is measured	18 months	Periapical index score(PAI) is used for assessment

Trial Locations

Locations (1)

Csi College of Dental Sciences and Research; 🇮🇳 Madurai, Tamil NADU, India