Apico Marginal Defects Clinical Trial
Official title:
To Evaluate the Efficacy of Guided Tissue Regeneration in the Healing of Periapical Defects With Periodontal Communication :A Randomized Controlled Trial With 3D Analysis Using CBCT."
Healing of the Apicomarginal defects will be checked by comparing 2 groups . In first group amniotic membrane will be applied over the defect before flap closure during surgery and in second group no GTR material will be applied. Healing of the lesions will also be compared 2 dimensionaly and 3 dimensionaly using CBCT
Study Title: - To evaluate the efficacy of guided tissue regeneration in the healing of
periapical defects with periodontal communication: A randomized controlled trial with 3D
analysis using CBCT.
Rationale: - Healing of lesions with apicomarginal defects is often less satisfactory.
Various studies and case reports have reported high success rate with the use of guided
tissue regeneration technique. Only few clinical trials have evaluated the effect of guided
tissue regeneration on the healing of apicomarginal defects. To best of our knowledge only
two studies have conducted randomized controlled trial. However, no study has used CBCT for
the assessment of healing in such type of lesions. So, this is the first randomized
controlled trial studying the effect of guided tissue regeneration in the healing of
periapical defects with periodontal communication using 3D radiological evaluation using
CBCT.
Aim & Objectives: - 1. To evaluate the difference in the healing outcome of periapical
defects with periodontal communication with or without the use of guided tissue regeneration
technique 2. To evaluate the difference in the healing outcome derived from the assessment of
2D periapical radiographs and 3 D CBCT imaging.
Setting: - Study will be conducted in Post Graduate Institute of Dental Sciences, Rohtak in
the department of Conservative Dentistry & Endodontics.
Study Design: - A randomized controlled trial Time Frame: - 12 to 18 months Population /
Participants: - Patients of age 16 years (male/female) and above will be enrolled in the
study.
Inclusion criteria: - Patients of age 16 years and above, Patients with no general medical
contraindications for oral surgical procedures (ASA-I and ASA-II according to the
classification of the American Society of Anesthesiologist's, periapical defect with
periodontal communication, periodontal pocket >6mm with apicomarginal communication confined
to buccal aspect of interproximal space or mid buccal aspect of the root ., -ve response to
vitality test, failed previous root canal treatment with purulent discharge or failed
previous surgery or recurrent episode of purulent discharge.
Exclusion criteria: -Presence of buccal bone on flap elevation, Unrestorable tooth, fractured
/perforated roots, smokers, pregnant females and lactating mothers.
Sample size: - 30 patients (15 patients in each group) Methods: - Diagnosis of the lesion
will be made clinically and radiographically, vitality will be checked by EPT, preoperative
clinical evaluation will include, clinical attachment level, gingival marginal position and
pocket depth. Marginal bone loss, width of bony crypt, height of the bony crypt, depth of the
crypt and height of the buccal bone plate (if present) will be measured radiographically and
at the time of surgery. Surgical procedures will be carried out under operating microscope
with 8 × 16 magnification by the standardized treatment methods.
Outcome measures: - Follow up of patients will be carried out at 3, 6, 9 & 12 months and
outcome measures will be assessed clinically by absence of signs and symptoms and 2
dimensionally using radiographs by Rud and Molven criteria for periapical healing and 3
dimensionaly using CBCT by modified PENN criteria at 12 months follow up for periapical
healing and buccal bone level.
Statistical method: - The data will be entered into Microsoft Excel and analysed using SPSS
(Statistical Package for Social Science) package for relevant statistical comparison.
Distribution of data into normal and non-normal will be done by Kolmogorov-Smir-Nov test. If
the data will be normal then student T test and paired T test will be applied for unpaired
and paired data respectively. For categorical data Chi - square test will be applied. The
interobserver analysis will be done by cohen kappa analysis.
If the data will be non-normal then Mann - Whitney and Wilcoxon rank sum test will be applied
for unpaired and paired data respectively. For categorical data Chi - square test will be
applied. The interobserver analysis will be done by cohen kappa analysis.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04396743 -
Comparative Evaluation of Two PRF Formulations on Quality of Life and Healing of Apicomarginal Defects
|
N/A |