Pulpotomy in Primary Molars Treated With Premixed Bio-ceramic MTA Versus Formocresol

Study Overview
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Brief Summary
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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
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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: Pain to the percussion will be assessed by gentle tapping on the tooth with the end of a dental mirror mobility will be assessed through the back of two mirrors 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.

Official Title
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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.

Conditions
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Caries

Intervention / Treatment
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* Drug: Formocresol
* Drug: Premixed bioceramic MTA


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: control group<br>the group that have caries in primary molars and treat them with formocresol | Drug: Formocresol<br>* dressing agents in pulpotomized primary molas using formocresol in cariously exposed vital primary molars<br>|
| Experimental: experimental group<br>the group that have caries in primary molars and treat them with premixed bioceramic MTA | Drug: Premixed bioceramic MTA<br>* dressing agents in pulpotomized primary molas using premixed bioceramic MTA in cariously exposed vital primary molars<br>* Other names: Neoputty;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. Binary (present or absent) | at 0 day | 
| 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. Binary (present or absent) | at 3 month | 
| 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. Binary (present or absent) | at 6 month | 
| 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. Binary (present or absent) | at 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • Pain to the percussion | will be assessed by gentle tapping on the tooth with the end of a dental mirror. Binary (present or absent) | at 0 day | 
| • Pain to the percussion | will be assessed by gentle tapping on the tooth with the end of a dental mirror. Binary (present or absent) | at 3 month | 
| • Pain to the percussion | will be assessed by gentle tapping on the tooth with the end of a dental mirror. Binary (present or absent) | at 6 month | 
| • Pain to the percussion | will be assessed by gentle tapping on the tooth with the end of a dental mirror. Binary (present or absent) | at 1 year | 
| mobility | • Mobility is scored on a scale of 1-3 as follows: the movement that is greater than normal (physiological) movement. a maximum of 1 mm in the buccolingual direction. depreciable buccolingual movement of more than 1 mm. Miller's Grades | at 0 day | 
| mobility | • Mobility is scored on a scale of 1-3 as follows: the movement that is greater than normal (physiological) movement. a maximum of 1 mm in the buccolingual direction. depreciable buccolingual movement of more than 1 mm. Miller's Grades | at 3 month | 
| mobility | • Mobility is scored on a scale of 1-3 as follows: the movement that is greater than normal (physiological) movement. a maximum of 1 mm in the buccolingual direction. depreciable buccolingual movement of more than 1 mm. Miller's Grades | at 6 month | 
| mobility | • Mobility is scored on a scale of 1-3 as follows: the movement that is greater than normal (physiological) movement. a maximum of 1 mm in the buccolingual direction. depreciable buccolingual movement of more than 1 mm. Miller's Grades | at 1 year | 
| radiographic indications of radiolucency and pathologic root resorption (periapical or bifurcation) will be examined (present or not). | Binary (present or absent) | at 0 day | 
| radiographic indications of radiolucency and pathologic root resorption (periapical or bifurcation) will be examined (present or not). | Binary (present or absent) | at 3 month | 
| radiographic indications of radiolucency and pathologic root resorption (periapical or bifurcation) will be examined (present or not). | Binary (present or absent) | at 6 month | 
| radiographic indications of radiolucency and pathologic root resorption (periapical or bifurcation) will be examined (present or not). | Binary (present or absent) | at 1 year |