BACKGROUND: Multicenter clinical trials have established that the adjunctive use of the subgingival controlled release of chlorhexidine, (CHX chip), significantly reduces probing depth (PD), improves clinical attachment levels, and reduces bleeding on probing compared to scaling and root planing (SRP) alone for periods of up to 9 months. The present report is based on a phase IV clinical trial to examine the adjunctive use of the CHX chip for routine periodontal maintenance therapy (RPMT) over 2 years. METHODS: Eight hundred thirty-five (835) patients were recruited into the study. At baseline a CHX chip was placed in pocket sites with PD > or = 5 mm. The patients were scheduled to receive RPMT at 3-month intervals with repeated CHX chip placement at sites where the PD remained > or = 5 mm. Patients who did not attend the 24-month recall visit or who failed to attend 2 consecutive time frame examinations were excluded from the analyses. RESULTS: The 595 patients included showed a continuous decrease in PD over 2 years of 0.95 mm. After 2 years, 23.2% of patients had at least 2 pockets showing a reduction in PD of 2 mm or more and 58.9% of the sites had been reduced to a PD of < 5 mm. Only 2.9% (n = 57) of the sites showed an increase in PD of > or = 2 mm. Adverse events were mild to moderate in nature and resolved spontaneously without medication. CONCLUSION: The results of this Phase IV or follow-up trial indicate that the adjunctive use of the CHX chip is a clinically safe and effective treatment option for long-term management of chronic periodontitis.
BACKGROUND: Multicenter clinical trials have established that the adjunctive use of the subgingival controlled release of chlorhexidine, (CHX chip), significantly reduces probing depth (PD), improves clinical attachment levels, and reduces bleeding on probing compared to scaling and root planing (SRP) alone for periods of up to 9 months. The present report is based on a phase IV clinical trial to examine the adjunctive use of the CHX chip for routine periodontal maintenance therapy (RPMT) over 2 years. METHODS: Eight hundred thirty-five (835) patients were recruited into the study. At baseline a CHX chip was placed in pocket sites with PD > or = 5 mm. The patients were scheduled to receive RPMT at 3-month intervals with repeated CHX chip placement at sites where the PD remained > or = 5 mm. Patients who did not attend the 24-month recall visit or who failed to attend 2 consecutive time frame examinations were excluded from the analyses. RESULTS: The 595 patients included showed a continuous decrease in PD over 2 years of 0.95 mm. After 2 years, 23.2% of patients had at least 2 pockets showing a reduction in PD of 2 mm or more and 58.9% of the sites had been reduced to a PD of < 5 mm. Only 2.9% (n = 57) of the sites showed an increase in PD of > or = 2 mm. Adverse events were mild to moderate in nature and resolved spontaneously without medication. CONCLUSION: The results of this Phase IV or follow-up trial indicate that the adjunctive use of the CHX chip is a clinically safe and effective treatment option for long-term management of chronic periodontitis.