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

Not Applicable
Not yet recruiting
Conditions
Dental Caries in Children
Interventions
Other: MTA based pulpotomy
Other: Collagen based pulpotomy
Registration Number
NCT05829304
Lead Sponsor
sherouk atef elsayed
Brief Summary

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

Detailed 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 & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
19
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Collagen based pulpotomyMTA based pulpotomyApplication of rubber dam for isolation, then a standardized pulpotomy procedure will be performed. Remove pulpal tissues to the orifice level. Haemostasis will be achieved by the application of a wet cotton pellet. Group I collagen-based Pulpotomy: 1. After complete haemostasis, collagen based pulpotomy will be applied according to the manufacturer's instructions and gently placed over the pulp stumps to a thickness of 2 mm then the rest of the pulp chamber will be filled with glass ionomer cement. 2. Tooth will be restored with stainless steel crown.
MTA based pulpotomyMTA based pulpotomyApplication of rubber dam for isolation, then a standardized pulpotomy procedure will be performed. Remove pulpal tissues to the orifice level. Haemostasis will be achieved by the application of a wet cotton pellet. Group II MTA pulpotomy: 1. After complete hemostasis, MTA+ Cerkamed will be manipulated to obtain a putty mix. This mix will be placed over the radicular pulp. condensation of the mix with a moistened cotton pellet, followed by application of glass ionomer cement. 2. Tooth will then be restored with stainless steel crown.
Collagen based pulpotomyCollagen based pulpotomyApplication of rubber dam for isolation, then a standardized pulpotomy procedure will be performed. Remove pulpal tissues to the orifice level. Haemostasis will be achieved by the application of a wet cotton pellet. Group I collagen-based Pulpotomy: 1. After complete haemostasis, collagen based pulpotomy will be applied according to the manufacturer's instructions and gently placed over the pulp stumps to a thickness of 2 mm then the rest of the pulp chamber will be filled with glass ionomer cement. 2. Tooth will be restored with stainless steel crown.
MTA based pulpotomyCollagen based pulpotomyApplication of rubber dam for isolation, then a standardized pulpotomy procedure will be performed. Remove pulpal tissues to the orifice level. Haemostasis will be achieved by the application of a wet cotton pellet. Group II MTA pulpotomy: 1. After complete hemostasis, MTA+ Cerkamed will be manipulated to obtain a putty mix. This mix will be placed over the radicular pulp. condensation of the mix with a moistened cotton pellet, followed by application of glass ionomer cement. 2. Tooth will then be restored with stainless steel crown.
Primary Outcome Measures
NameTimeMethod
postoperative pain3 days

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.

Secondary Outcome Measures
NameTimeMethod
absence of swellingup to 24 week

binary outcome detected with periapical x-ray by parallel technique using XCP film holder

Absence of internal root resorptionup to 24 week

binary outcome detected with periapical x-ray by parallel technique using XCP film holder

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