Medical Management of Caries in the Primary Dentition Using Silver Nitrate
Study Details
Study Description
Brief Summary
This pilot trial compares conventional restorations with a new strategy based on the medical management of caries using silver nitrate and fluoride varnish with no restorations.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Early Phase 1 |
Detailed Description
This is a two-arm, parallel group, patient-randomized controlled pilot trial. Children with at least one primary tooth where caries extends into dentine. Children will be randomized and treated according to one of two treatment approaches;(1) conventional caries management with best practice prevention, or (2) medical management of caries using silver nitrate with best practice prevention.
Baseline measures and outcome data (at treatment/review during two year follow-up) are assessed through direct reporting, clinical examination including blinded radiographic assessment, and child/parent questionnaires.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: conventional treatment group The child will receive a prophylaxis and fluoride varnish. Parents will fill out a parent and a child questionnaire. |
Procedure: Prophylaxis
A dental prophylaxis is a cleaning procedure performed to thoroughly clean the teeth. Prophylaxis is an important dental treatment for halting the progression of periodontal disease and gingivitis.
Other Names:
Drug: Fluoride varnish
Fluoride varnish is a highly concentrated form of fluoride which is applied to the tooth's surface, by a dentist, dental hygienist or other health care professional, as a type of topical fluoride therapy.
Other Names:
|
| Other: Silver Nitrate group The child will receive a prophylaxis, then silver nitrate and then fluoride varnish. Parents will fill out a parent and a child questionnaire. |
Procedure: Prophylaxis
A dental prophylaxis is a cleaning procedure performed to thoroughly clean the teeth. Prophylaxis is an important dental treatment for halting the progression of periodontal disease and gingivitis.
Other Names:
Drug: Fluoride varnish
Fluoride varnish is a highly concentrated form of fluoride which is applied to the tooth's surface, by a dentist, dental hygienist or other health care professional, as a type of topical fluoride therapy.
Other Names:
Drug: Silver Nitrate
a small amount will be applied to the tooth via a cotton applicator. Silver nitrate is a colorless, odorless, transparent solution used as an escharotic, dehydrating and sclerosing agent.
|
Outcome Measures
Primary Outcome Measures
- Change in baseline Caries Experience and activity (Incidence of caries in primary teeth) [through study completion, for 2 years]
Detailed measurements of caries experience will be recorded at baseline and annual caries examination using EC4
Secondary Outcome Measures
- Caries activity in primary teeth [through study completion, for 2 years]
Detailed measurements of caries activity will be recorded at baseline and annual caries examination using Nyvad scores.
Other Outcome Measures
- Pain (toothache) and/or infection in primary teeth [through study completion, for 2 years]
Assessments for pain from toothache will be made at each visit throughout the patient's participation in the trial using the Dental Discomfort Questionnaire completed by the parents.
- Patient quality of life [through study completion, for 2 years]
Quality of life will be assessed through direct reporting by parents and children about pain and related activities
- Cost-effectiveness [through study completion, for 2 years]
Cost-effectiveness for both groups will be calculated and compared
- Acceptability of treatment strategies by parents and children [through study completion, for 2 years]
Acceptability is checked throughout the whole period of the study every time the patient comes in for a recall
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Presense of one or more cavitated carious lesions in the primary dentition, extending into dentin but not encroaching on the pulp.
-
Absense of any spontaneous or elicited pain due to caries, or signs of pulpal infection in response to any of the carious lesions in the primary dentition to be included in the study
Exclusion Criteria:
-
Hereditary developmental defects of the teeth such as Amelogenesis Imperfecta and Dentinogenesis Imperfecta
-
Medical conditions that prevent treatment of the child in the outpatient clinic. These conditions include severe bleeding disorders, cardiac problems and mental disabilities that prevent child from communication with the research team.
-
Known allergy/sensitivity to any of the dental materials.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UIowa | Iowa City | Iowa | United States | 52242 |
Sponsors and Collaborators
- Arwa Owais
- Delta Dental of Iowa
Investigators
- Principal Investigator: Arwa I Owais, BDS, MS, Associate Profesor in Pediatric Dentistry
- Principal Investigator: MIchael Kanellis, DDS, MS, Professor in Pediatric Dentistry & Dean for Patient Cares
Study Documents (Full-Text)
None provided.More Information
Publications
- Duffin S. Back to the future: the medical management of caries introduction. J Calif Dent Assoc. 2012 Nov;40(11):852-8. Erratum in: J Calif Dent Assoc. 2012 Dec;40(12):909.
- Innes NP, Stewart M. The Hall Technique, a Simplified Method for Placing Stainless Steel Crowns on Primary Molars, may be as Successful as Traditionally Placed Crowns. J Evid Based Dent Pract. 2015 Jun;15(2):70-2. doi: 10.1016/j.jebdp.2015.03.008. Epub 2015 Mar 28.
- Keightley A, Clarkson J, Maguire A, Speed C, Innes N. Participant recruitment to FiCTION, a primary dental care trial - survey of facilitators and barriers. Br Dent J. 2014 Nov;217(10):E22. doi: 10.1038/sj.bdj.2014.1009.
- Klein U, Kanellis MJ, Drake D. Effects of four anticaries agents on lesion depth progression in an in vitro caries model. Pediatr Dent. 1999 May-Jun;21(3):176-80.
- Peng JJ, Botelho MG, Matinlinna JP. Silver compounds used in dentistry for caries management: a review. J Dent. 2012 Jul;40(7):531-41. doi: 10.1016/j.jdent.2012.03.009. Epub 2012 Apr 3. Review.
- Santamaria R, Innes N. Trial shows partial caries removal is an effective technique in primary molars. Evid Based Dent. 2014 Sep;15(3):81-2. doi: 10.1038/sj.ebd.6401044.
- Santamaria RM, Innes NP, Machiulskiene V, Evans DJ, Splieth CH. Caries management strategies for primary molars: 1-yr randomized control trial results. J Dent Res. 2014 Nov;93(11):1062-9. doi: 10.1177/0022034514550717. Epub 2014 Sep 12.
- Schwendicke F, Stolpe M, Innes N. Conventional treatment, Hall Technique or immediate pulpotomy for carious primary molars: a cost-effectiveness analysis. Int Endod J. 2016 Sep;49(9):817-826. doi: 10.1111/iej.12537. Epub 2015 Sep 19.
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