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

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.

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

Study Overview

• Status: Not yet recruiting
• Conditions: Caries
• Intervention / Treatment: Drug: Formocresol; Drug: Premixed bioceramic MTA

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: sarah A Mahmoud, B.D.S; Phone Number: 01023469565; Email: sarah_mahmoud@dentistry.cu.edu.eg
• Study Contact Backup: Name: maiI A Mahmed, PHD; Phone Number: 01012632608; Email: mai.ali@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 6 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sarah Abdelbar Mahmoud
• Investigators: Study Chair: ahmed m Elkhadem, Ass.Prof, Cairo university

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2022
• Primary Completion (Anticipated): April 1, 2023
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: March 25, 2022
• First Submitted That Met QC Criteria: April 2, 2022
• First Posted (Actual): April 6, 2022

Study Record Updates

• Last Update Posted (Actual): April 6, 2022
• Last Update Submitted That Met QC Criteria: April 2, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 203 (UNIMIB Ethic Commettee)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No