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This study will compare Cone beam Computed Tomography and Periapical radiography in detection and measurement of periapical lesions and healing outcomes following periapical surgery.
Study will be conducted in Post Graduate Institute of Dental Sciences, Rohtak in the department of Conservative Dentistry & Endodontics.
Study Design: - Prospective clinical trial
Time Frame: - Jan 2019 to April 2020
Population / Participants: -Patients of age 18 years and above will be enrolled in the study.
Sample size: - The anticipated change in treatment plan was expected to be 53% before and after using CBCT. Based on the available data , sample size was calculated to enroll a minimum of 18 patients in each group with a power level of 90% and alpha at the 5% level. Considering the dropouts, a total of 50 patients (n=25 each group) will be recruited for the study.
Method: - Study subjects will be recruited from the pool of patients enrolling in the Outpatient department meeting the inclusion criteria in the Post Graduate Department of Conservative Dentistry & Endodontics at PGIDS, Rohtak ,Haryana. Study will be performed after obtaining due ethical clearance from Institutional Ethical Committee of PGIDS. Patients are randomly divided into 2Dimensional periapical radiography (PA) group and 3Dimensional Cone beam computed tomography (CBCT) group. Preoperative radiographs (both PA radiography and CBCT) will be taken and periapical surgical procedures will be carried out under operating microscope by the standardized treatment methods.
Surgical Technique:
With the exception of incisions, flap elevation and suturing, all surgical procedures will be performed under operating microscope in an operating room under 8x to 16x magnification.
The full thickness (mucoperiosteal flap) will be reflected under aseptic conditions -
Post - Operative Follow-Up:
Clinical and 2D periapical radiographic examinations will be performed every 3, 6, 9 and 12 months by assessing the same parameters as baseline except that PD, CAL will not be measured until 12 months .CBCT scan will be done at 12 months follow up . Routine examination procedure will be used to evaluate any evidence of clinical signs and/or symptoms. Postoperative complications and Oral Health Related Quality of Life (OHQoL) questionnaire response will be assessed.
Healing Outcome measurement:
2D Radiographic healing will be assessed by the criteria followed by Rud et al (1972) and Molven et al (1987) Score 1 - Complete healing, defined by re-establishment of the lamina dura Score 2 - Incomplete healing (scar tissue) Score 3 - Uncertain healing Score 4 - Unsatisfactory healing (failure)
Patient assessment of quality of life following surgical endodontic treatment:
Each patient received a questionnaire to fill out for each day starting the day of surgery for 7 days postoperatively. The questionnaire consisted of 15 questions in which patients were to evaluate their quality of life with the 5-point Likert- type scale, ranging from 1 (not at all) to 5 (very much).
3 Dimensionally at 12 months of follow up periapical healing will be assessed by modified PENN 3D criteria: Score 1 - Complete healing Score 2 - Limited healing Score 3 - Uncertain healing Score 4 - Unsatisfactory healing
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. 3D CBCT GROUP | Experimental | Preoperative 3-dimensional CBCT will be taken. |
|
| 2D PR GROUP | Active Comparator | Preoperative 2-dimensional periapical radiographs will be taken using paralleling technique with customized Jig |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| periapical surgery | Procedure | clinical signs and symptoms, probing depth, Clinical attachment level (CAL ), dimensions of lesion, distance from the defect and apex of tooth to the anatomical structures will be measured |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative healing | Radiographic healing will be assessed in periapical radiography and CBCT after 12 months | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life assessment | likert scale of 1 to 5 1- not at all 5 - very much | till 1 wek after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Post Graduate Institute of Dental Science | Rohtak | Haryana | 124001 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36135595 | Derived | Gurusamy K, Duhan J, Tewari S, Sangwan P, Gupta A, Mittal S, Kumar V, Arora M. Patient-centric outcome assessment of endodontic microsurgery using periapical radiography versus cone beam computed tomography: A randomized clinical trial. Int Endod J. 2023 Jan;56(1):3-16. doi: 10.1111/iej.13837. Epub 2022 Oct 2. |
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| ID | Term |
|---|---|
| D010483 | Periapical Diseases |
| ID | Term |
|---|---|
| D007571 | Jaw Diseases |
| D009057 | Stomatognathic Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
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