Abstract
BackgroundThe aim of this prospective placebo-controlled pilot study was to evaluate short-term effects of a mouthrinse containing aluminium triformate (ATF) on gingival inflammation and plaque formation in periodontal patients who are in the maintenance phase. ATF has styptic (astringent) and anti-inflammatory effects.MethodsForty non-smoking periodontal patients with modified sulcus bleeding index (MSBI) ≥40 % were randomly divided into two groups. The participants received a masked mouthrinse (ATF or placebo) and were instructed with the rinsing protocol of 3 daily rinses during 30 s for 7 days. One blinded investigator (CE) performed all clinical examinations. The primary outcome was reduction in gingival inflammation as measured by MSBI. The secondary outcomes were reduction of the amount of plaque as measured by plaque index (PI) and approximal plaque index (API) and the occurrence of side effects. The patients were evaluated at the start and the end of the rinsing period, including the compliance of the patients.ResultsMSBI was reduced in both groups compared to baseline, but the ATF group showed significantly more reduction in MSBI compared to the placebo group (ATF: 17.6 %, placebo: 7.6 %, p = 0.035). ATF and placebo had no effects on dental plaque. Patients reported ATF mouthrinse not to have side effects other than oral sensation, whereas compliance of the patients was good. Almost all patients in the ATF group reported reduction of gum bleeding after 1 week of rinsing with ATF.ConclusionsThis short-term pilot clinical trial is a firm basis to design a long-term controlled clinical trial to show whether ATF helps to inhibit further periodontal breakdown in maintenance patients with high MSBI.Trial registrationThis trial was registered in the WHO International Clinical Trials Registry Platform as DRKS00007672, date of registration: 21/01/2015.Electronic supplementary materialThe online version of this article (doi:10.1186/s12903-016-0214-z) contains supplementary material, which is available to authorized users.
Highlights
The aim of this prospective placebo-controlled pilot study was to evaluate short-term effects of a mouthrinse containing aluminium triformate (ATF) on gingival inflammation and plaque formation in periodontal patients who are in the maintenance phase
We considered it necessary first to perform a short-term study as a pilot for an extensive clinical trial for two reasons: 1° we wanted to test the compliance of the patients who participated in the study and 2° we wanted to monitor side effects
Study population and patient characteristics A total of 101 periodontal patients were assessed for eligibility and 42 met the inclusion and exclusion criteria and were enrolled (Fig. 2)
Summary
The aim of this prospective placebo-controlled pilot study was to evaluate short-term effects of a mouthrinse containing aluminium triformate (ATF) on gingival inflammation and plaque formation in periodontal patients who are in the maintenance phase. Tools and chemical compounds in addition to mechanical plaque control may be helpful to support oral health. Additional chemical plaque control as part of domestic oral hygiene has always been playing an important role in the treatment of gingival inflammation [2, 3]. Periodontal treatment includes non-surgical and surgical procedures and domestic oral hygiene regimes. The maintenance phase after periodontal treatment is as important as the treatment itself and plays a decisive role whether the long-term outcome is successful or not [4]. Continuous domestic oral hygiene is indispensable to reach this aim and suitable antiseptics may help
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