A Comparative Clinical and Radiographic Study Of Collagen Based Pulpotomy in Cariously Exposed Vital Primary Molars

Dental Caries in Children Clinical Trial

Official title:

A Comparative Clinical and Radiographic Study Of Collagen Based Pulpotomy Versus MTA Pulpotomy in Cariously Exposed Vital Primary Molars

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05829304
• Other study ID #: 251293
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: April 2023
• Source: Cairo University
• Contact: Sherouk Elsayed, bachelor
• Phone: +201005544373
• Email: sherouk.elsayed[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess post operative pain and survival rate after collagen based pulpotomy versus MTA pulpotomy in children with vital primary molars.

Description:

Pulpotomy of vital primary molars is indicated when caries removal results in pulp exposure. Treatment approaches consist of devitalization using formocresol, preservation using ferric sulfate and regeneration using mineral trioxide aggregate of the remaining pulp tissue have been utilized to date. The ideal pulpotomy medicament would be biocompatible and bactericidal, in addition, to promote the healing of the root pulp and be compatible with the physiological process of root resorption.

Collagen, which is available for dental implication, is already sterilized and also reinforced with antibiotic particles to efficiently aid in regeneration and repair without any contaminations. The collagen particles can be sterilized by various methods like irradiation, dry heat, and ethylene oxide, among which irradiation is the most frequently used method as it does not affect the structural stability

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 19
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 6 Years

Eligibility

Inclusion Criteria:

1. Primary molar tooth not more than one-third of root resorption.

2. Children with bilateral deep dental caries approximating the pulp in primary molars assessed both clinically and radiographically.

3. systemically healthy.

4. cooperative patients who will comply to follow up visits.

Exclusion Criteria:

1. Children with medical, physical, or mental conditions.

2. Primary molars with any congenital deformities.

3. Previously accessed teeth.

4. At operative procedure haemorrhage control is unachievable after pulpotomy.

Related Conditions & MeSH terms

• Dental Caries
• Dental Caries in Children

Intervention

Other:
• MTA based pulpotomy
The principal investigator will carry out all treatment procedures, and the patients will be assigned. It will be as split mouth, both groups A&B will be at the same patient.
• Collagen based pulpotomy
The principal investigator will carry out all treatment procedures, and the patients will be assigned. It will be as split mouth, both groups A&B will be at the same patient.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
sherouk atef elsayed	Cairo University

References & Publications (1)

Anandan V, Inbanathan J, Saket P, Krishnamoorthy V, Gandhi S, Chandrababu VK. Assessment of Clinical and Radiographic Success Rate of Formocresol-based Pulpotomy versus Collagen-based Pulpotomy: An In Vivo Study. J Contemp Dent Pract. 2021 Jun 1;22(6):680-685. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative pain	postoperative pain following the placement of restoration by questioning the patient. using numerical pain rating scale Zero means patient have no pain, while 10 represents the most intense pain possible.	3 days
Secondary	Absence of internal root resorption	binary outcome detected with periapical x-ray by parallel technique using XCP film holder	up to 24 week
Secondary	absence of swelling	binary outcome detected with periapical x-ray by parallel technique using XCP film holder	up to 24 week