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Trial registered on ANZCTR


Registration number
ACTRN12618001265268
Ethics application status
Approved
Date submitted
18/07/2018
Date registered
26/07/2018
Date last updated
26/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of nanosilver and chlorhexidine in the treatment of plaque-induced gingivitis
Scientific title
clinical efficacy of nanosilver and chlorhexidine in the treatment of plaque-induced gingivitis: randomized controlled clinical trial
Secondary ID [1] 295559 0
nil known
Universal Trial Number (UTN)
U1111-1216-9312
Trial acronym
ENCTG
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Plaque-induced gingivitis 308831 0
Condition category
Condition code
Oral and Gastrointestinal 307761 307761 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a triple-blinded randomized controlled comparative trial of four weeks duration investigating the efficacy of a locally available nanosilver and chlorhexidine mouth wash in the treatment of plaque-induced gingivitis. Subjects received a dental prophylaxis in the past two weeks prior to the baseline examination.
Enrolled subjects were then randomly divided into two groups:
(1) Control group who rinsed with 0.12% CHX Chlorhexidine Glucognate mouthwash utilizing 10 mL twice daily for one minute.
(2) Experimental group who rinsed with less than 0.01% NS Nanosilver mouthwash utilizing 10 mL twice daily for one minute.

All patients received a complete dental prophylaxis to remove all plaque, calculus and extrinsic stain before entering the study. The participants were motivated on regular intervals by personal and phone contact to use soft tooth brush, brush only with similar toothpaste (Colgate) and to brush their teeth twice daily, once in the morning after breakfast and once in the evening before bedtime. They were instructed to brush a minimum of 3 minutes to ensure thorough brushing. They also were informed about the same brushing technique (bass technique). They were instructed to rinse their mouth with mouth wash at least half an hour after tooth brushing and instructed not to take any liquid o food for at least 30 minutes. The subjects were instructed not to take any liquid or food into the mouth for at least 30 minutes after using mouth wash to avoid reduction the substantively of mouth wash, thus decreasing the efficacy of the mouth wash and to diminish the side effects of CHX like staining and bad taste. Then we contacted the patients every day at the morning and evening during a period of study by missed calls and message text to remind them. After one week from rinse use the patients returned the empty bottles to receive another one and delivery of the patient diary supplied by the researcher.
Intervention code [1] 301859 0
Treatment: Drugs
Comparator / control treatment
Control group is the 0.12% Chlorhexidine mouthwash for 4 weeks duration.
Control group
Active

Outcomes
Primary outcome [1] 306747 0
Change in gingivitis assessed by clinical intra-oral examination (plaque, gingival, papilla bleeding scores).
Timepoint [1] 306747 0
the clinical indices were taken at baseline (primary timepoint) , two weeks, and finally at four weeks (primary endpoint) for each patient.
Primary outcome [2] 306813 0
comparison in gingivitis changes between the nanosilver and chlorhexidine assessed by clinical intra-oral examination (plaque, gingival, papilla bleeding scores).
Timepoint [2] 306813 0
the clinical indices were taken at baseline (primary timepoint) , two weeks, and finally at four weeks (primary endpoint) for each patient.
Secondary outcome [1] 349429 0
Presence of bacteria assessed by plaque sampling and culturing on blood agar media.
Timepoint [1] 349429 0
plaque sample were taken at baseline, two weeks, and finally at four weeks for each patient.

Eligibility
Key inclusion criteria
The inclusion criteria of this study comprised good general health, availability for the 4 weeks duration of the study, patients who have evidence of plaque-induced gingivitis without periodontitis, and a minimum of 20 natural teeth, excluded third molars.
Minimum age
18 Years
Maximum age
28 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects were excluded from the study if they had any of the following conditions: orthodontic bands; partial removable dentures; pregnant or breast feeding women; subjects who had systemic disorders and/or undertake medication which might influence the periodontal; individuals with history of allergic to oral consumer products; smoking; patients who received periodontal treatment or antibiotic therapy any time during the one month prior to entry into the study; subjects who had tumor(s) or significant pathology in the soft or hard tissues of the oral cavity; five or more carious lesions needful immediate care.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis
The analysis of the data was performed using SPSS 21.0 for Windows (SPSS Inc., Chicago, IL, USA). The Mann-Whitney U-test was used to determine statistical significance of mean values between groups (intergroup analysis). The clinical parameters and bacterial count (CFUs) within the groups were as evaluated using the Wilcoxon signed rank test (intragroup analysis). The significance level was set at p < 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 10646 0
Yemen
State/province [1] 10646 0
sana’a

Funding & Sponsors
Funding source category [1] 300136 0
University
Name [1] 300136 0
University of science and technology
Address [1] 300136 0
Sana’a- Yemen
Country [1] 300136 0
Yemen
Primary sponsor type
University
Name
University of science and technology
Address
Sana’a- Yemen
Country
Yemen
Secondary sponsor category [1] 299538 0
None
Name [1] 299538 0
None
Address [1] 299538 0
None
Country [1] 299538 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300971 0
Faculty of Medicine and Health Sciences (research ethics committee)
Ethics committee address [1] 300971 0
University of science and technology (UST)- Sana,a city- sixty street- UST tour
Ethics committee country [1] 300971 0
Yemen
Date submitted for ethics approval [1] 300971 0
05/06/2016
Approval date [1] 300971 0
01/07/2016
Ethics approval number [1] 300971 0
MECA No. 2016/22

Summary
Brief summary
This is a two stage project:
(1) Randomized controlled clinical trial to test the null hypothesis that was there is no difference in the clinical efficacy on treatment of plaque-induced gingivitis between nanosilver and chlorhexidine mouthwashes (primary hypothesis) and plaque, gingival and papilla bleeding scores reduction and improvement after two and four weeks from mouth rinsing (secondary hypothesis) followed by
(2) Microbiological study to assess antimicrobial efficacy of nanosilver mouthwash and compared with chlorhexidine mouthwash on treatment of plaque-induced gingivitis and to confirm the counting of the bacteria after application of the mouth wash to the patient and taking the plaque sample.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85466 0
Dr Dr Amani Al-sharani
Address 85466 0
Oral Medicine and Periodontology Department, College of Dentistry, University of Sciences and Technology at Sana’a- Yemen
Country 85466 0
Yemen
Phone 85466 0
00967775200206
Fax 85466 0
Email 85466 0
a.alsharani@ust.edu
Contact person for public queries
Name 85467 0
Prof Prof Ahmed Madfa
Address 85467 0
Restorative and Prosthodontic Department, College of Dentistry, University of Science and Technology, Yemen
Country 85467 0
Yemen
Phone 85467 0
00967774302577
Fax 85467 0
Email 85467 0
ahmed_um_2011@yahoo.com
Contact person for scientific queries
Name 85468 0
Prof Waddah Al-Hajj
Address 85468 0
Department of Conservative Dentistry, Faculty of Dentistry, Thamar University, Yemen.
Country 85468 0
Yemen
Phone 85468 0
00967773446446
Fax 85468 0
Email 85468 0
waddah.alhaj@gmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary