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| Name | Class |
|---|---|
| Delta Dental of Iowa | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| conventional treatment group | Other | The child will receive a prophylaxis and fluoride varnish. Parents will fill out a parent and a child questionnaire. |
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| Silver Nitrate group | Other | The child will receive a prophylaxis, then silver nitrate and then fluoride varnish. Parents will fill out a parent and a child questionnaire. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prophylaxis | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in baseline Caries Experience and activity (Incidence of caries in primary teeth) | Detailed measurements of caries experience will be recorded at baseline and annual caries examination using EC4 | through study completion, for 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Caries activity in primary teeth | Detailed measurements of caries activity will be recorded at baseline and annual caries examination using Nyvad scores. | through study completion, for 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Pain (toothache) and/or infection in primary teeth | 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. | through study completion, for 2 years |
| Patient quality of life |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arwa I Owais, BDS, MS | Associate Profesor in Pediatric Dentistry | Principal Investigator |
| MIchael Kanellis, DDS, MS | Professor in Pediatric Dentistry & Dean for Patient Cares | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UIowa | Iowa City | Iowa | 52242 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23270129 | Background | Duffin S. Back to the future: the medical management of caries introduction. J Calif Dent Assoc. 2012 Nov;40(11):852-8. | |
| 10355008 | Background | 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. |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D005459 | Fluorides |
| D012835 | Silver Nitrate |
| ID | Term |
|---|---|
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D007287 | Inorganic Chemicals |
| D006858 |
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the radiographic progression of caries is assessed by a masked investigator
|
| Fluoride varnish | Drug | 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. |
|
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| Silver Nitrate | Drug | 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. |
|
Quality of life will be assessed through direct reporting by parents and children about pain and related activities |
| through study completion, for 2 years |
| Cost-effectiveness | Cost-effectiveness for both groups will be calculated and compared | through study completion, for 2 years |
| Acceptability of treatment strategies by parents and children | Acceptability is checked throughout the whole period of the study every time the patient comes in for a recall | through study completion, for 2 years |
| 22484380 | Background | 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. |
| 26331379 | Background | 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. |
| 25987388 | Background | 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. No abstract available. |
| 25415040 | Background | 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. |
| 25343394 | Background | 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. |
| 25216660 | Background | 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. |
| 26492796 | Result | Lamont T, Schwendicke F, Innes N. Why we need a core outcome set for trials of interventions for prevention and management of caries. Evid Based Dent. 2015 Sep;16(3):66-8. doi: 10.1038/sj.ebd.6401109. No abstract available. |
| 26346538 | Result | Schwendicke F, Lamont T, Innes N. Outcomes in Trials for Management of Caries Lesions (OuTMaC): protocol. Trials. 2015 Sep 7;16:397. doi: 10.1186/s13063-015-0927-3. |
| Hydrofluoric Acid |
| D017611 | Fluorine Compounds |
| D009566 | Nitrates |
| D017942 | Nitric Acid |
| D017672 | Nitrogen Compounds |
| D018030 | Silver Compounds |