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

Caries Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05314842
• Other study ID #: 203
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: April 1, 2022
• Est. completion date: May 1, 2023

Study information

• Verified date: March 2022
• Source: Cairo University
• Contact: sarah A Mahmoud, B.D.S
• Phone: 01023469565
• Email: sarah_mahmoud[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: May 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• Caries

Intervention

Drug:
• Formocresol
dressing agents in pulpotomized primary molas using formocresol in cariously exposed vital primary molars
• Premixed bioceramic MTA
dressing agents in pulpotomized primary molas using premixed bioceramic MTA in cariously exposed vital primary molars

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sarah Abdelbar Mahmoud

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	• 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
Secondary	• 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
Secondary	• 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
Secondary	• 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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	radiographic indications of radiolucency and pathologic root resorption (periapical or bifurcation) will be examined (present or not).	Binary (present or absent)	at 0 day
Secondary	radiographic indications of radiolucency and pathologic root resorption (periapical or bifurcation) will be examined (present or not).	Binary (present or absent)	at 3 month
Secondary	radiographic indications of radiolucency and pathologic root resorption (periapical or bifurcation) will be examined (present or not).	Binary (present or absent)	at 6 month
Secondary	radiographic indications of radiolucency and pathologic root resorption (periapical or bifurcation) will be examined (present or not).	Binary (present or absent)	at 1 year