Clinical trial NCT05314842: Pulpotomy in Primary Molars Treated With Premixed Bio-ceramic MTA Versus Formocresol
Official title: Clinical and Radiographic Evaluation of Pulpotomy in Primary Molars Treated With Premixed Bio-ceramic MTA Versus Formocresol Among a Group of Egyptian Children: A Pilot Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Caries
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-04-06
Enrollment: 40
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: examine the results of pulpotomy in primary molars using premixed bioceramic MTA versus Formocresol. Clinical and radiographic success rates were used as outcomes.

Detailed description: Primary outcome:

Soft-tissue pathology

* Post-treatment swelling will be assessed through visual examination by the operator, either intraorally or extra orally.
* Sinus tract or fistula will be assessed through visual examination by the operator

Secondary outcomes:

1. Pain to the percussion will be assessed by gentle tapping on the tooth with the end of a dental mirror
2. mobility will be assessed through the back of two mirrors
3. radiographic assessments:- for any radiolucency and pathologic root resorption (periapical or bifurcation) will be examined (present or not).

clinical assessment on every recall visit during the 3-, 6-, and 12-month follow-up period.

• These radiographic assessments will be performed as baseline data at the first visit following the operating procedure, as well as at 3, 6, and 12 months after the baseline.

Eligibility criteria: Inclusion Criteria:

* Medically fit and cooperative children.
* Pediatric patients aged 4-6 years.
* A deep carious lesion in vital primary molars.
* Absence of clinical signs and symptoms of pulpal exposure.
* Absence of radiographic signs and symptoms of people degeneration.
* Positive parental informed consent.

Exclusion Criteria:

Uncooperative children.

* Medically compromised children.
* Presence of clinical signs and symptoms of pulpal exposure.
* Presence of radiographic signs and symptoms of pulp degeneration.
* Physiologic root resorption more than one-third.

Primary outcomes:
measure: Soft-tissue pathology
timeFrame: at 0 day
measure: Soft-tissue pathology
timeFrame: at 3 month
measure: Soft-tissue pathology
timeFrame: at 6 month
measure: Soft-tissue pathology
timeFrame: at 1 year
Secondary outcomes:
measure: • Pain to the percussion
timeFrame: at 0 day
measure: • Pain to the percussion
timeFrame: at 3 month
measure: • Pain to the percussion
timeFrame: at 6 month
measure: • Pain to the percussion
timeFrame: at 1 year
measure: mobility
timeFrame: at 0 day
measure: mobility
timeFrame: at 3 month
measure: mobility
timeFrame: at 6 month
measure: mobility
timeFrame: at 1 year
measure: radiographic indications of radiolucency and pathologic root resorption (periapical or bifurcation) will be examined (present or not).
timeFrame: at 0 day
measure: radiographic indications of radiolucency and pathologic root resorption (periapical or bifurcation) will be examined (present or not).
timeFrame: at 3 month
measure: radiographic indications of radiolucency and pathologic root resorption (periapical or bifurcation) will be examined (present or not).
timeFrame: at 6 month
measure: radiographic indications of radiolucency and pathologic root resorption (periapical or bifurcation) will be examined (present or not).
timeFrame: at 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: ahmed m Elkhadem, Ass.Prof
role: STUDY_CHAIR
References: