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

Primary Purpose

Fractured Tooth

Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Surgical extrusion
Fibre post
Sponsored by
Tamil Nadu Dr.M.G.R.Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fractured Tooth

Eligibility Criteria

15 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Csi College of Dental Sciences and ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Surgical extrusion

Fibre post

Arm Description

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

Treatment modality normally used for crown-root fractured tooth

Outcomes

Primary Outcome Measures

Radiographic healing of teeth is measured
Periapical index score(PAI) is used for assessment

Secondary Outcome Measures

Full Information

First Posted
December 16, 2020
Last Updated
March 29, 2021
Sponsor
Tamil Nadu Dr.M.G.R.Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04685161
Brief Title
Comparison of Surgical Extrusion vs. Fibre Post Restoration for Crown-root Fractured Maxillary Incisors.
Official Title
Comparison of Surgical Extrusion vs Fibre Post Restoration for Crown-root Fractured Maxillary Incisors. Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 15, 2021 (Actual)
Primary Completion Date
May 2022 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tamil Nadu Dr.M.G.R.Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fractured Tooth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2 groups are used One using fibre post placement And the other using surgical extrusion
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Surgical extrusion
Arm Type
Experimental
Arm Description
Novel and alternative treatment option for horizontal crown root fractured maxillary incisors
Arm Title
Fibre post
Arm Type
Active Comparator
Arm Description
Treatment modality normally used for crown-root fractured tooth
Intervention Type
Procedure
Intervention Name(s)
Surgical extrusion
Intervention Description
Invasive treatment option for fractured tooth
Intervention Type
Device
Intervention Name(s)
Fibre post
Intervention Description
Easy approach for treatment
Primary Outcome Measure Information:
Title
Radiographic healing of teeth is measured
Description
Periapical index score(PAI) is used for assessment
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
RAHUL BASKAR, MDS
Phone
9 1 7598326175
Email
raghulram22@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
ANAND SHERWOOD, MDS
Phone
919791443050
Email
anand.sherwood@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ANAND SHERWOOD, MDS
Organizational Affiliation
TNMGRMU
Official's Role
Study Director
Facility Information:
Facility Name
Csi College of Dental Sciences and Research
City
Madurai
State/Province
Tamil NADU
ZIP/Postal Code
625001
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rahul B Dr, MDS
Phone
7598326175
Email
raghulram22@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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