Treatment effectiveness of pulpotomy as compared to pulpectomy for management of symptomatic irreversible pulpitis in primary teeth: A randomized controlled trial
Overview
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- ESIC dental College and Hospital
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Clinical and radiographic outcomes will be assessed independently by two trained, calibrated examiners and shall be blinded to the treatment or follow up time interval.
Overview
Brief Summary
This parallel, two-armed, non-inferiority randomized controlled trial will be conducted as per CONSORT guidelines.
A total of 100 primary teeth diagnosed with irreversible pulpitis will be recruited for the study in 100 children aged 4 to 10 years. The interventions (pulpotomy and pulpectomy) will be randomly allocated to children meeting inclusion criteria in ratio of 1:1 using sequentially numbered opaque sealed envelopes of varied length blocks. The researcher performing the procedure will be blinded to the block sizes and the randomization sequence. The bio-dentine material will be used as pulp medicament for pulpotomy and Metapex (Iodoform and calcium hydroxide paste) as obturating material for pulpectomy procedure and standard clinical procedural guidelines will be used. All the treatment teeth will be restored finally restored with composite restoration and SSC.
Pre-operative and post-operative pain intensity will be assessed using the Visual Analogue Scale. All the teeth receiving the two interventions will be evaluated for clinical and radiographic outcomes by two independently, trained, calibrated and blinded (for time duration) examiners at 24 hrs, 7 days, 3 months, 6 months and one year follow up duration. Survival analysis will be calculated for the two procedures for the follow up period.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Eligibility Criteria
- Ages
- 4.00 Year(s) to 10.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Healthy children with carious teeth between the ages of 4 to 10 years will be invited to participate in the study inclusion criteria: (i) symptoms typical of irreversible pulpitis (ii) the primary molar is restorable with stainless steel crown; and (iii) iv) any physiologic root resorption, if present, is less than 1/3 the normal root length.
Exclusion Criteria
- •(i) clinical sign/symptoms of pathologic tooth mobility, parulis/fistula, or soft tissue swelling; (ii) preoperative periapical radiograph suggests presence of furcal radiolucency more than ½ the furcation to periapical area; (iii) pre-operative periapical radiograph suggests presence of periapical radiolucency/pathological root resorption (iv) Intra-operatively, visual examination of pulp tissue reveals signs of necrosis i.e., avascular/minimally bleeding pulp tissue or yellowish necrotic areas/purulent exudate.
Outcomes
Primary Outcomes
Clinical and radiographic outcomes will be assessed independently by two trained, calibrated examiners and shall be blinded to the treatment or follow up time interval.
Time Frame: 3 months 6 months 12 months
Clinical success of the treated tooth will be determined based on no clinical symptoms of pain/tenderness on percussion/ parulis/fistula/soft tissue swelling/pathological mobility etc.
Time Frame: 3 months 6 months 12 months
Radiographic success will be determined by no signs of pathological changes.
Time Frame: 3 months 6 months 12 months
Secondary Outcomes
- Survival analysis will be calculated for the two procedures for the follow up period.(one year)
- Pre-operative and post-operative pain intensity will be assessed using the Visual Analogue Scale.(at 24 h and 7 days)
Investigators
Hitesh Chander
ESIC dental college and hospital Kalaburagi