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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Fractured Tooth
• Intervention / Treatment: Procedure: Surgical extrusion; Device: Fibre post

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 Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: RAHUL BASKAR, MDS; Phone Number: 9 1 7598326175; Email: raghulram22@gmail.com
• Study Contact Backup: Name: ANAND SHERWOOD, MDS; Phone Number: 919791443050; Email: anand.sherwood@gmail.com

Study Locations

• India
  • Tamil NADU
    • Madurai, Tamil NADU, India, 625001
      • Recruiting
      • CSI College of Dental Sciences and Research
      • Contact: Rahul B Dr, MDS; Phone Number: 7598326175; Email: raghulram22@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Surgical extrusion; Novel and alternative treatment option for horizontal crown root fractured maxillary incisors	Procedure: Surgical extrusion; Invasive treatment option for fractured tooth
Active Comparator: Fibre post; Treatment modality normally used for crown-root fractured tooth	Device: Fibre post; Easy approach for treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic healing of teeth is measured	Periapical index score(PAI) is used for assessment	18 months

Collaborators and Investigators

• Sponsor: Tamil Nadu Dr.M.G.R.Medical University
• Investigators: Study Director: ANAND SHERWOOD, MDS, TNMGRMU

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2021
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: December 16, 2020
• First Submitted That Met QC Criteria: December 24, 2020
• First Posted (Actual): December 28, 2020

Study Record Updates

• Last Update Posted (Actual): March 30, 2021
• Last Update Submitted That Met QC Criteria: March 29, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Stomatognathic Diseases; Tooth Diseases; Tooth Injuries; Fractures, Bone; Tooth Fractures
• Other Study ID Numbers: CSICOLLEGE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No