Prevention of Adult Caries Study (PACS)
Maneno muhimu
Kikemikali
Maelezo
The Prevention of Adult Caries Study (PACS) is a randomized, double-blind, placebo-controlled Phase III clinical trial conducted under F.D.A. Investigational New Drug license #45,466, with a target enrollment of 1000 at four clinical centers with vastly different populations. The centers participating in this proposed research are: Kaiser Permanente's Dental Plan in Portland, Oregon; Tufts University Dental Clinic in central Boston, Massachusetts; Delta Dental Massachusetts' Dental Clinic in Southborough, Massachusetts; and the dental clinic of the Tuba City Regional Health Care Corporation in Tuba City, Arizona. Kaiser Permanente's Center for Health Research in Portland, Oregon will act as the data-coordinating center, and Tufts University will act as the Administrative Center. This study is designed to evaluate the efficacy of a topical, temporary, 10% w/v chlorhexidine dental coating in reducing caries increment in at-risk adult dental patients. This study will treat participants in months 1(4 weekly applications) and 7(1 application) with final outcome measured at 13 months after randomization. Examiners were trained and certified before data collection started and were recalibrated annually. The primary outcome analysis in the intent -to- treat sample compares active to placebo group on the rank-normalized caries increment score, adjusting for examiner, age and age squared. Multiple imputation (data augmentation using MCMC) will be used to replace missing outcome. Planned secondary analysis examine the secondary caries increment outcomes using the same model, as well as parallel analyses in the per-protocol group. Safety of the coating will be evaluated by comparing development of resistant S. mutans or C. albicans as well as incidence of MedDRA-coded adverse events between the two arms.
Tarehe
Imethibitishwa Mwisho: | 04/30/2017 |
Iliyowasilishwa Kwanza: | 07/25/2006 |
Uandikishaji uliokadiriwa Uliwasilishwa: | 07/25/2006 |
Iliyotumwa Kwanza: | 07/27/2006 |
Sasisho la Mwisho Liliwasilishwa: | 05/14/2017 |
Sasisho la Mwisho Lilichapishwa: | 06/13/2017 |
Tarehe ya matokeo ya kwanza yaliyowasilishwa: | 10/17/2016 |
Tarehe ya matokeo ya kwanza ya QC yaliyowasilishwa: | 05/14/2017 |
Tarehe ya matokeo ya kwanza kuchapishwa: | 06/13/2017 |
Tarehe halisi ya kuanza kwa masomo: | 06/30/2006 |
Tarehe ya Kukamilisha Msingi iliyokadiriwa: | 07/31/2009 |
Tarehe ya Kukamilisha Utafiti: | 05/31/2010 |
Hali au ugonjwa
Uingiliaji / matibabu
Drug: Active Dental Coating
Other: Placebo Dental Coating
Awamu
Vikundi vya Arm
Mkono | Uingiliaji / matibabu |
---|---|
Placebo Comparator: Placebo Dental Coating Dental coating with all ingredients except Chlorhexidine topically applied by dental professional supragingivally to the full dentition | Other: Placebo Dental Coating |
Active Comparator: Active Dental Coating 10% w/v chlorhexidine acetate coating FDA IND #45466. Dental coating with all ingredients including Chlorhexidine topically applied by dental professional supragingivally to the full dentition | Drug: Active Dental Coating Dental coating topically applied by dental professional supragingivally to the full dentition |
Vigezo vya Kustahiki
Zama zinazostahiki Kujifunza | 18 Years Kwa 18 Years |
Jinsia Inastahiki Kujifunza | All |
Hupokea Wajitolea wa Afya | Ndio |
Vigezo | Inclusion Criteria: - 18 years of age and older - at least 20 intact natural teeth, excluding third molars - 2 or more lesions, of which at least one must be a cavitated D2 or D3 - willing and able to provide informed consent Exclusion Criteria - pregnant or planning to become pregnant or planning to become pregnant during the study (breastfeeding is permitted) - use of fixed orthodontic appliances - allergic to any of the ingredients of the study medication - long-term antibiotic therapy - a history of, or currently active, radiation therapy for cancers of the head or neck - Sjögren's syndrome - advanced periodontitis - consumption of the equivalent of more than five servings of acidic or sugared drinks per day - having 10 or more lesions requiring restorative care at the time of the screening visit - remineralization therapy within one month of randomization - investigator discretion |
Matokeo
Hatua za Matokeo ya Msingi
1. Total Net D12FS Caries Increment (Total of Non-cavitated Lesions (D1), Cavitated Lesions (D2) and Sound Surfaces (S)) [(V1) to the 13 month follow-up visit]
Hatua za Matokeo ya Sekondari
1. Cumulative Net D12FS Caries Increment [Visit 1, 7-month follow-up, 13-month follow-up]
2. Total Crude D12FS Caries Increment [V1-13-month follow-up]
3. Cumulative Crude D12FS Caries Increment [Visit 1, 7-month follow-up, 13-month follow-up]