Clinical and Radiographic Evaluation of Partial Pulpotomy Versus Complete Pulpotomy in Vital Pulp Therapy in Primary Molars Using NeoPUTTY™ (MTA): Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Cairo University
- Enrollment
- 60
- Primary Endpoint
- Mobility
Overview
Brief Summary
Evaluating the clinical and radiographic success of partial pulpotomy compared to complete pulpotomy in vital primary second molars with reversible pulpitis using NeoPUTTY™ (MTA).
Detailed Description
Children with symptoms of reversible pulpitis in their second primary molar will be chosen to be enrolled in the study, and then randomly allocated into two groups. One group will undergo partial pulpotomy and the other group complete pulpotomy and followed up for 12 months. The blinding of the operator is not possible due to the nature of the technique used. Trial participants, outcome assessors and statistician will be blinded.
- Informed consent from participating children's parents.
- Baseline records photographs, percussion test, periapical radiograph and personal data collection.
- Diagnostic chart with personal, medical and dental history will be filled.
- Allocation (concealed by withdrawing a sealed opaque envelope containing Four-folded numbered papers containing the type of vital pulp therapy technique that will be used then writing the patient's name and I.D. on it and will be opened after removing the carious lesion).
- Clinical examination will be performed to assess the clinical inclusion criteria. (Pulpal and periapical diagnoses are established after clinical examination).
- Preoperative and Postoperative photographs will be taken.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 4 Years to 7 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients:
- •Aged 4-7 years, in good general health and medically within normal.
- •Restorable mandibular second primary molars.
- •History of reversible pulpitis.
- •Preoperative radiograph:
- •Absence of periapical or inter-radicular radiolucency.
- •Absence of widening of periodontal ligaments (PDL) space.
- •Absence of internal or external root resorption.
Exclusion Criteria
- •Patients:
- •With systemic disorders.
- •Physical or mental disabilities.
- •Unable to attend follow-up visits.
- •Refusal of Participation.
- •Refusal to sign the informed consent.
- •Previously accessed teeth.
- •Mobile mandibular second primary molar.
- •Swelling in the vestibule or on palpation.
- •Pain on percussion.
Outcomes
Primary Outcomes
Mobility
Time Frame: 3, 6, 9, 12 months
Assesment of pathological mobility using mobility test.
Swelling/ Fistula
Time Frame: 3, 6, 9, 12 months
Assessment of swelling and fistula through visual examination.
Postoperative pain
Time Frame: one week postoperative
Postoperative pain assessment through Visual Analog Scale (the lower the value the better).
Secondary Outcomes
- Radiographic success(0, 6, 12 months)
Investigators
Yara Ayman
Internal resident of Pediatric Dentistry and Public Health, Cairo University
Cairo University