Caries management by risk assessment: The CaMBRA randomized clinical trial
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1 Caries management by risk assessment: The CaMBRA randomized clinical trial Principal Investigator: John D. B. Featherstone Co-investigators: Stuart A. Gansky, Chuck Hoover, Marcia Rapozo-Hilo, Kim Tran, Jane A. Weintraub, Joel White, Robert Wilson, Ling Zhan Mentored students: Lawrence Li, Gloria Khoo, Maureen Khoo, Dan Walton Support: US DHHS/NIH/NIDCR R01 DE In-kind: OMNII Pharmaceuticals, Oral B, Proctor & Gamble
2 Background: The Caries Balance Protective Factors Pathological Factors Acid-producing bacteria Frequent eating/drinking fermentable carbohydrates Sub-normal saliva flow & function Saliva flow & components Fluoride - remineralization Antibacterials: chlorhexidine, xylitol, new? Caries No Caries
3 chinowa Kyoto, Japan June 2001
4 Overall Aim of the Study The overall objective of the study was: To provide clinical evidence that caries risk assessment with aggressive preventive and therapeutic measures can restore the balance between caries pathological and protective factors, thereby reducing new caries formation over 2 years
5 Caries Management Study Salivary MS, LB, F every visit Visit 1 DMFS Radiographs Control Visit: Conventional Tx Plan Restorations 2 Randomization All Restorations Complete Years Final DMFS Radiographs Intervention Visit: 2 Restorations, Antibacterial +/-Fluoride Rinses high med low Salivary MS, LB, F every visit All Restorations Complete Final DMFS Radiographs
6 Methods Study Enrollment 3 yr randomized clinical trial: 231 adults (18+ yrs) Eligibility: 16+ teeth, 1-7 cavities, no root caries Restorations completed (RC) in average of 12 mo Saliva samples (paraffin stimulated) every 6 mo: selective microbiology (MS & LB, CFU/ml saliva) fluoride (F, ppm)
7 Methods Tx Grps Preventive Intervention (PI) Group (n=116) Chlorhexidine gluconate (0.12%) rinse, 1/day for 2 weeks every 3 months (or 1 week / month) based on salivary MS and LB levels Fluoride mouthrinse daily (0.05% NaF) based on salivary F level Control (C) Group - conventional care (n=115) No fluoride or chlorhexidine rinse supplied Providers unaware of salivary assay results 2 year follow-up after RC to final examination Final examination (1 calibrated examiner - JAW)
8 Overall Caries Risk Log 10 (Mutans Strep + 1) (CFU/ml) Low Medium High F > 0.08 ppm < <6.0 > 6.0 Log 10 (LB +1) (CFU/ml) Low < 1.3 Medium 1.3 <3.0 High > 3.0 Low Medium High Medium Medium High Medium High High
9 Decayed Surfaces vs. log MS and log LB Baseline Bacterial Levels vs Decay High Bacterial Challenge
10 5 Log MS vs Time Mean (SE) Restorations Log MS Control Log MS Intervention (CHX +/- F) Visit # - 6 month intervals
11 5 4 Log LB vs Time Mean (SE) Restorations Log LB Control Log LB Intervention (CHX +/- F) Visit # - 6 month intervals
12 Final Caries Status Related to Baseline Bacterial Levels CaMRA Randomized Clinical Trial
13 Final Caries Status Related to Baseline Bacterial Levels CaMRA Randomized Clinical Trial
14 Final Caries Status Related to Bacterial Levels 6 Months Prior CaMRA Randomized Clinical Trial
15 Final Caries Status Related to Bacterial Levels 6 Months Prior CaMRA Randomized Clinical Trial
16 Mean (SE) ΔDMFS, ΔDFS p = p = n=52 n=57 n=52 n=57
17 Limitations Lower enrollment than (231 not 296), but better retention than planned slightly smaller sample size (109 not 122) Compliance
18 Overall Conclusions Oral MS challenge stays essentially the same even after restoring all teeth with cavities Chlorhexidine gluconate (0.12%) +/- F (0.05% NaF) intervention is valuable during and after treatment to reduce caries risk status Caries risk status can be determined from MS, LB counts and F concentration in saliva Favorably altering the Caries Balance somewhat reduces subsequent caries levels
19 Did We Prove Our Hypothesis? This randomized clinical trial: provided clinical evidence that caries risk assessment with aggressive preventive and therapeutic measures can beneficially alter the balance between caries pathological and protective factors somewhat reducing new caries formation over 2 years
20 Reflections? Questions?
21
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