Evaluation of N-acetyl cysteine mouth wash as a new treatment approach for gingivitis

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2017
INTERVENTION: This study has two phases. Participant are randomly divided to three groups by drawing sealed and opaque envelopes containing the codes (A), (B), (C). The induction of experimental gingivitis will be done by instructing the participant not to brush their teeth during the period of study. This study will consist of two stages: Stage One (Preventative): This is a preventive stage in which the mouthwash is examined to prove its effect to prevent experimental gingivitis. They are also instructed not to drink, eat or rinse for thirty minutes after mouth washing. This stage is 21 days long. During this stage the participants are allocated to one of three groups: Group (A): 20 healthy gingiva participants, who use 10 ml of 0.25% N‐acetyl cysteine solution as mouth wash, twice daily for one minute (test group) Group (B): 20 healthy gingiva participants, who use 10 ml of 0.2% (CHX) twice daily for one minute (positive control group) Group (C): 20 healthy gingiva participants, who use 10 ml of water or placebo twice daily for one minute (negative control group) Stage Two (Treatment): After preventive stage, the placebo group (group C) are allocated to one of two groups in the treatment stage randomly by drawing sealed and opaque envelopes containing the codes (C1) and (C2): Group (C1): 10 experimental plaque‐induced gingivitis participants, who use 10 ml of 0.25% (NAC) solution as mouthwash, twice daily for one minute (test group). Group (C2): 10 experimental plaque‐induced gingivitis participants, who use 10 ml of 0.2% (CHX) twice daily for one minute (control group). The treatment stage includes CHX and the experimental new mouthwash NAC mouthwash used to treat the experimental plaque‐induced gingivitis. Participants are instructed not to drink, eat or rinse for thirty minutes after mouth washing. A comparison between the therapeutic effects of both mouthwashes is done. This stage lasts 14 days. Follow‐up includes visits for intra‐oral clinical examination and bacterial CONDITION: Gingivitis ; Oral Health ; Gingivitis PRIMARY OUTCOME: Bacteria in sub‐gingival plaque is measured using bacteria samples from the participants analyzed using DNA sequencing at baseline and day 21 and 35. SECONDARY OUTCOME: For the preventative and treatment stages:; 1. Plaque is measured using an index scoring system from 0‐3 at baseline and at day 7, 14, 21, 28 and 35; 2. Gingival index is measured using an index scoring system from 0‐3 at baseline and at day 7, 14, 21, 28 and 35; 3. Papilla bleeding is measured using an index scoring system from 1‐4 at baseline and at day 7, 14, 21, 28 and 35 INCLUSION CRITERIA: 1. Healthy gingiva with no evidence of periodontitis 2. Male and females aged between 18 to 28 3. Willing to participate and comply with the objectives of the study
Epistemonikos ID: f3d53d8876ce86f6b05afd892c82bd5d67716b1b
First added on: Aug 23, 2024