Pulp Disease, Dental
Conditions
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. 1. Informed consent from participating children's parents. 2. Baseline records photographs, percussion test, periapical radiograph and personal data collection. 3. Diagnostic chart with personal, medical and dental history will be filled. 4. 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). 5. Clinical examination will be performed to assess the clinical inclusion criteria. (Pulpal and periapical diagnoses are established after clinical examination). 6. Preoperative and Postoperative photographs will be taken.
Interventions
PROCEDUREPartial Pulpotomy
After removing caries high-speed handpiece with water coolant using a round diamond bur. Once there is an exposure, the bur is changed with another sterile one with which the superficially inflamed pulp tissue will be gently removed to a depth of 1-3 mm beneath the pinpoint pulp exposure that occurred at the end of caries removal. A sterile cotton pellet with saline will be placed with light pressure for 2-3 minutes to achieve hemostasis.
PROCEDUREComplete pulpotomy
After removing caries with a large round bur, the access cavity will be opened. Excavation of inflamed coronal pulp tissues will be done using a sharp excavator. A sterile cotton pellet with saline will be placed with light pressure for 2-3 minutes to achieve hemostasis.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 7 Years
Healthy volunteers
No
Inclusion criteria
* Patients: * Aged 4-7 years, in good general health and medically within normal. Teeth: * 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. Teeth: * Previously accessed teeth. * Mobile mandibular second primary molar. * Swelling in the vestibule or on palpation. * Pain on percussion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain | one week postoperative | Postoperative pain assessment through Visual Analog Scale (the lower the value the better). |
| Swelling/ Fistula | 3, 6, 9, 12 months | Assessment of swelling and fistula through visual examination. |
| Mobility | 3, 6, 9, 12 months | Assesment of pathological mobility using mobility test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic success | 0, 6, 12 months | Radiographic evaluation (Radiolucency at furcation or periapical, internal or external root resorption) through visual interpretation of digital radiograph at 0, 6 and 12 months postoperatively. |
Contacts
Primary ContactYara A. Badr, Masters
Outcome results
None listed