Dental Caries
Conditions
Keywords
indirect pulp, primary, calcium hydroxide, resin modified glass ionomer, Children
Brief summary
This study was conducted to evaluate the clinical and the radiographic success of Dycal and Vitrebond as indirect pulp treatment materials in primary molars.
Detailed description
Evaluation of calcium hydroxide and resin modified glass ionomer liner clinically and radiographically as indirect pulp treatment materials in deep caries in primary molars.
Interventions
DRUGIndirect pulp treatment using Dycal (TM)
Partial caries removal and protection of the dental pulp with biocompatible material
DRUGIndirect pulp treatment using Vitrebond (TM )
Partial caries removal and protection of the dental pulp with biocompatible material
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Double blinded
Intervention model description
Parallel group with 1:1 allocation ratio
Eligibility
Sex/Gender
ALL
Age
4 Years to 8 Years
Healthy volunteers
Yes
Inclusion criteria
In compliance with AAPD, 2017 guidelines for pulp therapy IPT is indicated in a primary tooth with no pulpitis or with reversible pulpitis when the deepest carious dentin is not removed to avoid a pulp exposure. The pulp is judged by clinical and radiographic criteria to be vital and able to heal from the carious insult In addition to: I-Subjects: 1. Medically free children, their parent(s) accepts to sign the informed consent. 2. Age range from 4-8 years. II-Molars: 1. Presence of at least 1 primary molar with deep carious lesion extending to more than one half of the dentin on radiographic examination (to make the trial regardless of number of carious molars). 2. Clinically: Normal mobility and normal appearance of gingiva (vital teeth). 3. Radiographically: Normal roots without physiological resorption, normal lamina dura and normal periodontal membrane space (indicated for IPT).
Exclusion criteria
I-Subjects: 1. Uncooperative children. 2. Parents unable to attend follow up visits (even after explaining the importance of recall visits). II-Molars: 1. History of spontaneous pain (to exclude reversible pulpitis). 2. Clinically: Presence of swelling, sinus, fistula or tooth mobility (to exclude non vital teeth). 3. Radiographically: Presence of radiolucent lesions at furcation or periapical region or external or internal resorption (to exclude teeth not indicated for IPT).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of cases reporting tooth mobility | 12 months | Presence of abnormal tooth mobility following dental treatment through tactile examination using two hand mirrors as a sign of clinical failure |
| Number of cases reporting postoperative pain | 12 months | Presence of postoperative pain following dental treatment through patient questionnaire as a sign of clinical failure |
| Number of cases reporting swelling | 12 months | Presence of postoperative swelling following dental treatment through visual examination using hand mirror as a sign of clinical failure |
| Number of cases reporting sinus | 12 months | Presence of sinus following dental treatment through visual examination using hand mirror as a sign of clinical failure |
| Number of cases reporting fistula | 12 months | Presence of fistula following dental treatment through visual examination using hand mirror as a sign of clinical failure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of cases reporting external root resorption | 12 months | Occurrence of pathological external root resorption following dental treatment through parallel periapical radiographic examination as a sign of radiographic failure |
| Number of cases reporting internal root resorption | 12 months | Occurrence of pathological internal root resorption following dental treatment through parallel periapical radiographic examination as a sign of radiographic failure |
| Number of cases reporting furcation involvement | 12 months | Occurrence of pathological internal root resorption following dental treatment through parallel periapical radiographic examination as a sign of radiographic failure |
| Number of cases reporting widening of periodontal membrane space | 12 months | Occurrence of widening of periodontal membrane space following dental treatment through parallel periapical radiographic examination as a sign of radiographic failure |
| Number of cases reporting periapical radiolucency | 12 months | Occurrence of periapical radiolucency following dental treatment through parallel periapical radiographic examination as a sign of radiographic failure |
Countries
Egypt
Outcome results
None listed