Tooth staining effect oftwo mouthwashes among old-age people living in an old-age home

Completed

• Conditions: Other general symptoms and signs, (2) ICD-10 Condition: K051||Chronic gingivitis,; Patients who are having Periodontitis.

• Registration Number: CTRI/2022/09/045284
• Lead Sponsor: Dr Karunanidhi K

Brief Summary

Dentists frequently recommend adjunctive oral hygiene aids such  as chlorhexidine (CHX) mouthwashes. CHX represents an effective option for the treatment of plaqueâ€induced gingival diseases, due to inhibition of bacterial biofilm buildâ€up and microbial reâ€colonization.But use of chlorhexidine mouthwash  may also lead to adverse effects such as  tooth staining, altered taste sensation, mucosal irritation. This reduces patient compliance towards the use of Chlorhexidine mouthwashes. To reduce the adverse effects and improve anti microbial efficacy, several components have been added to chlorhexidine mouthwash. Of that, a plasdone added mouthwash is being marketed as chlorhexidine mouthwash with Anti-Discoloartion System (Clohex ADS). However, there is no scientific evidence regarding evaluation of this mouthwash in prevention of tooth staining. Hence, this study was designed to comparatively evaluate the anti-staining effect of Chlorhexidine mouthwash with and without anti-discoloration system. This study will be conducted as a multi centric tripleâ€blinded, parallel study among Institutionalized old-age adults. The old age home people will be subjected for clinical examination. Participants meeting the inclusion criteria will be recruited into the study. All the selected participants will undergo complete ultrasonic scaling. In the same session, when professional oral hygiene was completed (T0), clinical indices such as Silness and Loe Plaque Index (1964) Gingival Bleeding Index (GBI—Ainamo Bay), Extrinsic Stain Index (Loebner), Intraoral digital photographs will be recorded for each patient. The participants will be randomly allocated to interventional groups **GROUP I:** Chlorhexdine Mouthwash Brand Name: Clohex Mouthwash (Dr.Reddy’s Laboratories) *Ingredients: Chlorhexidine 0.20 %***GROUP II:** Chlorhexidine Mouthwash with Anti-Discoloration System Brand Name: Clohex ADS (Dr.Reddy’s Laboratories) *Ingredients: Chlorhexidine 0.20 %, Sodium Fluoride 0.05%, Zinc chloride 0.09%.*A standard tooth brush (soft) and toothpaste will be provided to all participants. The participants will be asked to rinse their mouth with 10 ml of mouthwash twice daily for 1 minute. Silness and Loe Plaque Index(1964), Gingival Bleeding Index (GBI—Ainamo Bay), Extrinsic Stain Index (Loebner), intraoral digital photographs will be recorded at 15th day. The plaque levels, gingival bleeding and tooth staining will be compared between the two interventional groups. Patients’s perception towards the use of mouthwash will be recorded using a questionnaire. This study has certain benefits to the study participants.Tooth brushing is quite difficult for institutionalized geriatric population due to their limited manual dexterity. Tooth brushing alone can’t eliminate all the plaque from teeth. Hence, mouthwash use as an adjunctive oral hygiene aid, can bring down the plaque levels and improve the periodontal status of the participants. As well as, the mouthwash with least adverse effect can be evaluated through this trial and can be recommended to bed ridden, physically challenged and geriatric people. Hence, this study results has potential to extend it’s implications to the general population.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-09
• Study Completion: 2022-10-10
• Last Update Posted: 2022-10-19

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Participants aged more than 60 years of age.
• Participants who are able to perform tooth brushing and mouth rinsing on their own.
• Participants who are classified as Periodontitis stage II, III or stage IV according to classification of Tonetti, Greenwell, & Kornman, 2018 4.Participants with intact upper and lower anteriors.
• Participants willing to participate in the study.

Exclusion Criteria

• 1.Participants with missing of more than two upper and lower anteriors.
• 2.Participants with fixed partial dentures in upper and lower anteriors.
• 3.Participants who consume any form of smoke or smokeless tobacco.
• 4.Participants with psychological disorders.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess and compare the presence of extrinsic staining of teeth after the use of chlorhexidine mouthwashes with and without discoloration system.	At baseline | 7 days, 15 days

Secondary Outcome Measures

Name	Time	Method
1.To assess and compare the plaque content after the use of chlorhexidine mouthwashes with and without discoloration system	2.To assess and compare the presence of Gingival Bleeding after the use of chlorhexidine mouthwashes with and without discoloration system.

Trial Locations

Locations (2)

SRI SAIRAM OLD AGE HOMES (FOR FEMALES); 🇮🇳 Thiruvallur, TAMIL NADU, India

SRI SAIRAM OLD AGE HOMES (FOR MALES); 🇮🇳 Chennai, TAMIL NADU, India

SRI SAIRAM OLD AGE HOMES (FOR FEMALES)

🇮🇳Thiruvallur, TAMIL NADU, India

Dr Mohammed Meera Riyaz

Principal investigator

9994622501

meerariyaz.9@gmail.com