Clinical trial NCT04685161: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Fractured Tooth
Lead sponsor: Tamil Nadu Dr.M.G.R.Medical University
Sponsor class: OTHER
First posted: 2020-12-28
Enrollment: 140
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 groups are used One using fibre post placement And the other using surgical extrusion
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Radiographic healing of teeth is measured
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Madurai
country: India
facility: Csi College of Dental Sciences and Research
state: Tamil NADU
Study officials:
affiliation: TNMGRMU
name: ANAND SHERWOOD, MDS
role: STUDY_DIRECTOR
References: