Efficacy of an aluminium triformate mouthrinse during the maintenance phase in periodontal patients: a pilot double blind randomized placebo-controlled clinical trial

BACKGROUND 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. ATF has styptic (astringent) and anti-inflammatory effects. METHODS Forty 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. RESULTS MSBI 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. CONCLUSIONS This 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 REGISTRATION This trial was registered in the WHO International Clinical Trials Registry Platform as DRKS00007672 , date of registration: 21/01/2015.