Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04685161 |
| Other study ID # |
CSICOLLEGE |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 15, 2021 |
| Est. completion date |
May 2023 |
Study information
| Verified date |
March 2021 |
| Source |
Tamil Nadu Dr.M.G.R.Medical University |
| Contact |
RAHUL BASKAR, MDS |
| Phone |
9 1 7598326175 |
| Email |
raghulram22[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
