Impact of Periapical Radiography and Cone Beam Computed Tomography on Periapical Assessment Following Surgical Endodontic Treatment
Condition: Periapical Diseases
MeSH terms: Periapical Diseases
Study type: Interventional

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.
    

Detailed 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
    

Intervention name(s): periapical surgery
Intervention type(s): Procedure
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment