Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04333940 |
| Other study ID # |
Dr. G.Keerthana |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2019 |
| Est. completion date |
August 1, 2020 |
Study information
| Verified date |
December 2020 |
| Source |
Postgraduate Institute of Dental Sciences Rohtak |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study will compare Cone beam Computed Tomography and Periapical radiography in detection
and measurement of periapical lesions and healing outcomes following periapical surgery.
Description:
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 -
1. Preoperative mouth rinse with 0.2% chlorhexidine mouthwash will be used.
2. Local anaesthesia with lidocaine 2% with epinephrine 1:1,00,000 will be achieved.
3. Buccal intrasulcular incision will be given up to the alveolar crest including one tooth
mesial to the lesion & one tooth distal to the lesion, using no.15 BP blade.
4. Mesial and distal vertical releasing incision will be given.
5. Full thickness flap will be gently reflected towards the apical area by periosteal
elevator. The flap will be frequently irrigated with sterile saline to prevent
dehydration of periosteal surface.
6. After complete elevation of the flap, bone cutting is done using bur and complete
debridement of the bony lesion will be performed by surgical curettes For additional
hemostasis during surgery cotton pellets soaked in 0.1% epinephrine will be applied
topically as required.
7. A 2-3mm root tip with a 0º to 10º bevel angle will be resected with cylindrical surgical
carbide bur at high speed with sterile water coolant.
8. Root end preparations extending 3mm into the canal space along the long axis of the root
will be made using piezoelectric ultrasonic retrotips in both groups.
9. Isthmuses, fins, and other significant anatomic irregularities will be identified in
high magnification and will be treated with the ultrasonic instruments.
10. Root end filling will be done with mineral trioxide aggregrate (MTA). The adaptation of
the filling material to the canal apical walls will be confirmed with the aid of an
operating microscope at high magnification.
11. Later wound site will be closed and sutured with 4-0 silk suture after irrigating the
defect properly.
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
