Clinical and Radiographic Success of Biodentine Pulpotomy and Conventional Pulpectomy in Primary molars with Irreversible Pulpitis- A Split mouth design

Materials and Methods

Ethical Approval.

Ethical approval will be obtained from the Institutional Review Board of the Tamil Nadu Government Dental College and Hospital in the forthcoming session of the Board.

Study Design.

Randomised Controlled Trial- Split Mouth Design.

Study Population

Out Patients attending the Department of Pediatric and Preventive Dentistry, Tamil Nadu Government Dental College and Hospital, which is a teaching institution and a tertiary care dental hospital in Chennai city. Children with the following Inclusion and Exclusion criteria will be allowed to participate in the trial.

Inclusion Criteria

Children aged 5-8 years with

·       Bilaterally symmetrical carious molars with irreversible pulpitis

Exclusion Criteria

·       Children with more than 2/3rd physiological root resorption assessed radiographically

·       Children who present with signs of periapical or furcal infection such as presence of an abscess, sinus or fistula in relation to the concerned tooth.

·       Children who are uncooperative for the treatment procedure.

·       Children with conditions such as mental retardation, cerebral palsy, autism and medically compromised conditions such as liver, kidney diseases, cancer patients, blood dyscrasisas.

·       Non – compliant patients

·       Parents who do not consent their children to participate in this study.

Sample Size

A pilot and feasibility study will be conducted with 6 participants and the sample size will be estimated based on the pilot study.

Randomisation and Allocation Concealment

This study will follow a split mouth design where one tooth on one half of the arch will be subjected to biodentine pulpotomy and the other tooth on the other half of the arch will be subjected to the conventional pulpectomy treatment procedure. This allocation will be concealed by means of serially numbered opaque sealed envelopes (SNOSE).

Methodology

The patients attending the OPD of Department of Pediatric and Preventive Dentistry will be screened and those patients with the inclusion criteria mentioned above will be selected. Pre operative periapical radiographs will be taken for the concerned teeth with irreversible pulpitis. The parents will be explained about the treatment plan and those children whose parents are willing for their participation in the trial will be enrolled for the study. Informed consent will be obtained from the parents after explaining the details of the trial. The co-investigator will reveal the number obtained in the SNOSE. As per the number obtained, the concerned tooth will be allotted the appropriate treatment procedure. The most painful tooth will be treated first followed by the next tooth at the subsequent appointment. The entire treatment for all the patients enrolled in the study will be performed by the Principal Investigator.

Pulpotomy with Biodentine

On the day of the procedure, Local anesthesia will be administered for the concerned tooth. The entire procedure will be done under rubber dam isolation. After sufficient anesthesia is achieved, a conventional access cavity preparation for pulpotomy will be done as suggested by Finn9. The coronal pulp will be completely amputatedwith a sterile spoon excavator and the radicular pulp is left undisturbed. Complete irrigation of the pulp chamber is done with normal saline and hemostasis is achieved using a sterile cotton plug. Biodentine (Septodont, Saint-Maur-des-FossesCedex, France) is packed as per the manufacturer’s instructions to fill the entire pulp chamber leaving the occlusal 3 mm which is then filled with Glass Ionomer Cement (GIC) after the initial set of BD. The tooth is then restored with a preformed Stainless steel crown (SSC) and cemented with GIC.

Conventional Pulpectomy

On the day of the procedure, adequate anesthesia is achieved with the local anesthesthetic agent (2% Lignocaine with 1 in 80,000 adrenaline). Conventional access cavity preparation is done as suggested by Finn9. Complete pulp extirpation is done using hand files for endodontics (Hedstrom files and Kerr files) and barbed broaches. The canals are thoroughly irrigated with normal saline. After a complete biomechanical preparation of the canals, obturation will be done with calcium hydroxide Iodoform paste (Metapex/Cal-hyd, Meta BioMed). The chamber is then filled with Intermediate Restorative Material (IRM), leaving behind the occlusal 3mm which is then filled with GIC. The tooth will then be restored with a preformed SSC and luted with GIC.

Follow up

The patient will be recalled for follow up after 1 week, 1 month, 3 months, 6 months and 12 months. Outcome measurements will be ascertained in the follow up visits.

Outcomes

·       Subjective

Pain using Visual Analogue Scale (VAS).

·       Objective

Clinical

Tenderness on percussion.

Swelling.

Sinus or fistula opening.

Pathological mobility.

soft tissue changes.

Radiographic

Radiolucency in the furcation and periapical region.

Internal and External Resorption

Bone resorption

Lamina dura / Widening of periodontal ligament space.

Outcome Measurement

It will be ensured that the clinical and radiographic evaluations during the follow up visits will be performed by the Co-investigator who did not treat the patient and did not know the type of treatment that each tooth received. Radiographic outcomes will be measured from the 3rd month follow up visits.

Clinical success will be considered when no pain, tenderness, swelling, fistula, or pathological mobility are observed. Radiographic success will be characterized by a lack of evidence of radiolucency,internal and external resorption, bone resorption, integrity of the lamina dura and absence of PDL widening. Treatment failure will be characterized by one or more of the following symptoms: Persistent pain, swelling, sinus tract, internal andexternal root resorption, furcal radiolucency, periapical bone destruction, lack of integrity of the laminadura.

Statistical Analysis.

Data will be analyzed in the SPSS software. Since the data is qualitative in nature, analysis will be done by chi square test.