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

• Register: ISRCTN
• Last refreshed on: 7 December 2020
• Main ID: ISRCTN31352091
• Date of registration: 22/02/2017
• Prospective Registration: Yes
• Primary sponsor: University of Science and Technology
• Public title: Evaluation of N-acetyl cysteine mouth wash as a new treatment approach for gingivitis
• Scientific title: Efficacy of N-acetyl cysteine mouth wash in the prevention and treatment of experimental gingivitis: A randomised clinical trial
• Date of first enrolment: 01/03/2017
• Target sample size: 60
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN31352091
• Study type: Interventional
• Study design: Stage 1: Single-centre three-arm double-blind randomised controlled trial; Stage 2: Single-centre double-blind randomised parallel trial (Treatment)
• Phase: Phase II

Countries of recruitment

Yemen

Contacts

• Name: Ahlam Al-kamel

Key inclusion & exclusion criteria

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

Exclusion criteria:
1. Regular users of antiplaque rinses or the use of oral rinses for 30 days before baseline
2. Antibiotics intake within the previous 2 months
3. Smokers
4. Pregnancy or lactation
5. Systemic diseases or long term medications that influencing gingival conditions
6. Orthodontic appliance
7. Presence of detectable increased attachment loss
8. Chewing khat (flowering plant native to the Horn of Africa and the Arabian Peninsula)


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Gingivitis
Oral Health
Gingivitis

Intervention(s)

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 an

Primary Outcome(s)

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(s)

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

Secondary ID(s)

2016/20

Source(s) of Monetary Support

University of Science and Technology - Yemen

Ethics review

Status:
Approval date:
Contact:

Research Ethics Committee University of Sciences and Technology, 20/12/2016, ref: 2016/20

Results

• Results available: Yes
• Date Completed: 01/01/2018