Dental Caries in Children
Conditions
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
Interventions
OTHERMTA 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.
OTHERCollagen 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.
Sponsors
Cairo University
sherouk atef elsayed
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
the blinding is not possible (unfortunately) due to the nature of the trial. Trial participants, outcome assessors and statistician will be blinded.
Intervention model description
Teeth that will be included in the current trial will be randomly assigned one of the experimental groups using closed white envelopes (simple randomization 1:1 ratio).
Eligibility
Sex/Gender
ALL
Age
4 Years to 6 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| postoperative pain | 3 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
| Measure | Time frame | Description |
|---|---|---|
| Absence of internal root resorption | up to 24 week | binary outcome detected with periapical x-ray by parallel technique using XCP film holder |
| absence of swelling | up to 24 week | binary outcome detected with periapical x-ray by parallel technique using XCP film holder |
Contacts
Primary ContactSherouk Elsayed, bachelor
Backup Contactpassant nagi, lecturer
Outcome results
None listed