Status:
COMPLETED
Indirect Pulp Treatment in Primary Molars
Lead Sponsor:
Cairo University
Conditions:
Dental Caries
Eligibility:
All Genders
4-8 years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- 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:
- Medically free children, their parent(s) accepts to sign the informed consent.
- Age range from 4-8 years.
- II-Molars:
- 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).
- Clinically: Normal mobility and normal appearance of gingiva (vital teeth).
- Radiographically: Normal roots without physiological resorption, normal lamina dura and normal periodontal membrane space (indicated for IPT).
- Exclusion criteria:
- I-Subjects:
- Uncooperative children.
- Parents unable to attend follow up visits (even after explaining the importance of recall visits).
- II-Molars:
- History of spontaneous pain (to exclude reversible pulpitis).
- Clinically: Presence of swelling, sinus, fistula or tooth mobility (to exclude non vital teeth).
- Radiographically: Presence of radiolucent lesions at furcation or periapical region or external or internal resorption (to exclude teeth not indicated for IPT).
Exclusion
Key Trial Info
Start Date :
August 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2018
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT03770871
Start Date
August 1 2016
End Date
July 1 2018
Last Update
August 30 2019
Active Locations (1)
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1
Faculty of Oral and Dental Medicine
Cairo, Egypt, 11553