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

NCT ID: NCT04685161

Last Updated: 2021-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-15

Study Completion Date

2023-05-31

Brief Summary

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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

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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.

Conditions

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Fractured Tooth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

2 groups are used One using fibre post placement And the other using surgical extrusion
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Surgical extrusion

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

Group Type EXPERIMENTAL

Surgical extrusion

Intervention Type PROCEDURE

Invasive treatment option for fractured tooth

Fibre post

Treatment modality normally used for crown-root fractured tooth

Group Type ACTIVE_COMPARATOR

Fibre post

Intervention Type DEVICE

Easy approach for treatment

Interventions

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Surgical extrusion

Invasive treatment option for fractured tooth

Intervention Type PROCEDURE

Fibre post

Easy approach for treatment

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tamil Nadu Dr.M.G.R.Medical University

OTHER

Sponsor Role lead

Responsible Party

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Rahul Baskar

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ANAND SHERWOOD, MDS

Role: STUDY_DIRECTOR

TNMGRMU

Locations

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Csi College of Dental Sciences and Research

Madurai, Tamil Nadu, India

Site Status RECRUITING

Countries

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India

Central Contacts

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RAHUL BASKAR, MDS

Role: CONTACT

9 1 7598326175

ANAND SHERWOOD, MDS

Role: CONTACT

919791443050

Facility Contacts

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Rahul B Dr, MDS

Role: primary

7598326175

Other Identifiers

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CSICOLLEGE

Identifier Type: -

Identifier Source: org_study_id

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