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

NCT04685161 | Unknown DMC

• 1 other identifier: CSICOLLEGE
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Fractured Tooth

Outcome Measures

Primary Outcomes (1)

• Radiographic healing of teeth is measured

  Periapical index score(PAI) is used for assessment

  18 months

Study Arms (2)

Surgical extrusion

EXPERIMENTAL

Novel and alternative treatment option for horizontal crown root fractured maxillary incisors

Procedure: Surgical extrusion

Fibre post

ACTIVE COMPARATOR

Treatment modality normally used for crown-root fractured tooth

Device: Fibre post

Interventions

Surgical extrusion PROCEDURE

Invasive treatment option for fractured tooth

Surgical extrusion

Fibre post DEVICE

Easy approach for treatment

Fibre post

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tamil Nadu Dr.M.G.R.Medical University: lead

Study Sites (1)

Csi College of Dental Sciences and Research

Madurai, Tamil Nadu, 625001, India

RECRUITING

MeSH Terms

Conditions

Tooth Fractures

Condition Hierarchy (Ancestors)

Tooth Injuries; Tooth Diseases; Stomatognathic Diseases; Wounds and Injuries

Study Officials

• ANAND SHERWOOD, MDS

  TNMGRMU

  STUDY DIRECTOR

Central Study Contacts

RAHUL BASKAR, MDS

CONTACT

9 1 7598326175; raghulram22@gmail.com

ANAND SHERWOOD, MDS

CONTACT

919791443050; anand.sherwood@gmail.com

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: Principal investigator

Model Details: 2 groups are used One using fibre post placement And the other using surgical extrusion

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: December 28, 2020
• Study Start: January 15, 2021
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2023
• Last Updated: March 30, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)