After preliminary screening of personal medical history and oral examination at baseline, the participants were randomly assigned to one of the intervention groups: the toothbrush + oral irrigator group (test group) received an OI (WaterPik® ION Professional Cordless Water Flosser, marketed as GT17 on this region, WaterPik, Inc., Fort Collins, CO, USA) with a uniform standard manual toothbrush (Crest® Multicolored Crystal Soft Bristles, Procter and Gamble Co., Cincinnati, OH, USA) and a toothpaste (Crest® Anti-Cavity and Enamel Repair Toothpaste, Procter and Gamble Co., Cincinnati, OH, USA); the toothbrush group (control group) received an identical toothbrush and toothpaste. The OIs allowed for 10 adjustable water pressure settings ranging from 10 to 100 psi, which corresponded to 10 different switches. At baseline, the participants in the test group were instructed to use the OIs in the clinic for the first time by an experienced dental assistant. Furthermore, they were instructed to use the standard jet tip to flush the gingival margin and interdental space twice a day for approximately 90 s before toothbrushing. According to the manufacturer’s recommendations, the participants were advised to adopt the most comfortable water pressure level with a minimum of four. In addition, all participants were instructed to perform manual toothbrushing twice a day with the modified Bass technique. Participants were distributed electronic diaries to record the frequency of toothbrushing and oral irrigation and any adverse reactions or discomfort symptoms. Compliance was evaluated based on the diaries, and it was defined as toothbrushing or oral irrigation ≥ 2 × daily in >80% of study days. Instruction leaflets with toothbrushing methods and oral irrigation instructions were distributed to participants, and they were advised not to use other oral hygiene adjuncts, such as dental floss, interdental brush, and gum.
Before every clinical examination, all participants were instructed to refrain from oral hygiene for 12 h and fast for solids and liquids for 2 h. A single trained examiner evaluated all gingival inflammation-related indices. The MGI [27 ] were examined at four sites (mesial buccal, buccal, distal buccal, and lingual) per tooth. The Bleeding Index (BI) [28 (link)] and percentage of sites with bleeding on probing (BOP%) were examined at six sites (mesial buccal, buccal, distal buccal, mesial lingual, lingual, and distal lingual) per tooth using community periodontal index (CPI) probes. Another trained examiner evaluated the Turesky-Modified Quigley-Hein Plaque Index (T-QH) [29 (link)] after applying the dental plaque disclosing agent. Furthermore, a series of safety observation indicators were evaluated. Gingival recession is defined as apical migration of the gingival margin, and clinically visible sites of gingival recession were examined and recorded. The VAS was adopted to assess the pain and dentin hypersensitivity symptoms during the trial [30 (link)]. The left end of the line segment is marked for no pain or sensitivity symptoms, while the right end represents the most severe pain or sensitivity symptoms. The participants were instructed to mark the line segment according to their existing symptoms during the last month. In addition, vital signs of allergic reactions or lesions in the soft tissue of the oral cavity, including the gingiva, buccal mucosa, lips, palate, vestibular sulcus, tongue, and floor of the mouth, were recorded.
Participants returned to the clinical research center for dental examination at 4 weeks ± 3 days, 8 weeks ± 3 days, and 12 weeks ± 3 days after baseline examinations. The T-QH and gingival inflammation-related indices, including MGI, BI, and BOP%, were reevaluated. Furthermore, the safety indicators were also recorded. The modified Bass technique and the method of OIs use were reinforced at each visit by the same dental assistant. The primary outcomes were gingivitis-related indices after 12 weeks of using OIs. The secondary outcomes were plaque-related indices and gingivitis-related indices at 4 weeks and the safety indicators.
Before every clinical examination, all participants were instructed to refrain from oral hygiene for 12 h and fast for solids and liquids for 2 h. A single trained examiner evaluated all gingival inflammation-related indices. The MGI [27 ] were examined at four sites (mesial buccal, buccal, distal buccal, and lingual) per tooth. The Bleeding Index (BI) [28 (link)] and percentage of sites with bleeding on probing (BOP%) were examined at six sites (mesial buccal, buccal, distal buccal, mesial lingual, lingual, and distal lingual) per tooth using community periodontal index (CPI) probes. Another trained examiner evaluated the Turesky-Modified Quigley-Hein Plaque Index (T-QH) [29 (link)] after applying the dental plaque disclosing agent. Furthermore, a series of safety observation indicators were evaluated. Gingival recession is defined as apical migration of the gingival margin, and clinically visible sites of gingival recession were examined and recorded. The VAS was adopted to assess the pain and dentin hypersensitivity symptoms during the trial [30 (link)]. The left end of the line segment is marked for no pain or sensitivity symptoms, while the right end represents the most severe pain or sensitivity symptoms. The participants were instructed to mark the line segment according to their existing symptoms during the last month. In addition, vital signs of allergic reactions or lesions in the soft tissue of the oral cavity, including the gingiva, buccal mucosa, lips, palate, vestibular sulcus, tongue, and floor of the mouth, were recorded.
Participants returned to the clinical research center for dental examination at 4 weeks ± 3 days, 8 weeks ± 3 days, and 12 weeks ± 3 days after baseline examinations. The T-QH and gingival inflammation-related indices, including MGI, BI, and BOP%, were reevaluated. Furthermore, the safety indicators were also recorded. The modified Bass technique and the method of OIs use were reinforced at each visit by the same dental assistant. The primary outcomes were gingivitis-related indices after 12 weeks of using OIs. The secondary outcomes were plaque-related indices and gingivitis-related indices at 4 weeks and the safety indicators.
Free full text: Click here
