CTRI/2019/11/022140 [Registered on: 25/11/2019] Trial Registered Prospectively
Last Modified On:
20/11/2019
Post Graduate Thesis
Yes
Type of Trial
Interventional
Type of Study
Dentistry
Study Design
Randomized, Parallel Group Trial
Public Title of Study
comparison of two toothpastes on microorganisms in orthodontic patients
Scientific Title of Study
Comparison of the antimicrobial effect of Chlorhexidine digluconate toothpaste and Colgate Total toothpaste on the Streptococcus mutans levels in orthodontic patients.
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Deeksha S Innanje
Designation
post graduate student
Affiliation
SDM college of Dental Sciences and Hospital
Address
41,"SURYA",Madhura estate ,keshwapur, Hubli sattur, Dharwad Dharwad KARNATAKA 580023 India
Phone
8762722888
Fax
Email
deekshainnanje@gmail.com
Details of Contact Person Scientific Query
Name
Dr Deeksha S Innanje
Designation
post graduate student
Affiliation
SDM college of Dental Sciences and Hospital
Address
41,"SURYA",Madhura estate ,keshwapur, Hubli sattur, Dharwad Dharwad KARNATAKA 580023 India
Phone
8762722888
Fax
Email
deekshainnanje@gmail.com
Details of Contact Person Public Query
Name
Dr Shrinivas M Basavaraddi
Designation
professor
Affiliation
SDM college of Dental Sciences and Hospital
Address
SDM college of Dental Sciences and Hospital,sattur,dharwad SDM College of dental sciences and hospital
sattur, Dharwad Dharwad KARNATAKA 580009 India
Phone
9449824324
Fax
Email
drshrinivas6@gmail.com
Source of Monetary or Material Support
S D M College of Dental Sciences and Hospital, Sattur, Dharwad - 580009, Karnataka, India.
Primary Sponsor
Name
Dr Deeksha S Innanje
Address
Department of Orthodontics and Dentofacial
Orthopaedics S D M College of Dental Sciences and Hospital,
Sattur, Dharwad - 580009, Karnataka, India.
Type of Sponsor
Other [self]
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Deeksha S Innanje
S D M College of Dental Sciences and Hospital
Room No 5,
Department of
Orthodontics and
Dentofacial
Orthopaedics, S D M
College of Dental
Sciences and Hospital,
Sattur, Dharwad -
580009, Karnataka,
India.
Dharwad
KARNATAKA Dharwad KARNATAKA
8762722888
deekshainnanje@gmail.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
Institutional Review Board, S D M College of Dental Sciences and Hospital, Dharwad, Karnataka, India.
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Healthy Human Volunteers
No significant medical history
Intervention / Comparator Agent
Type
Name
Details
Intervention
Chlorhexidine Gluconate toothpaste
Chlorhexidine Gluconate solution containing 0.004% w/w will be applied pea size twice a day for a period of 1 month
Comparator Agent
Colgate Total toothpaste
0.3% triclosan, 2% copolymer and 0.243% sodium fluoride will be applied pea size for a single use ,twice a day for a period of one month
Inclusion Criteria
Age From
14.00 Year(s)
Age To
30.00 Year(s)
Gender
Both
Details
(1) Healthy patients (both genders) in the group of 14 to 25 years.
(2) Patients requiring fixed orthodontic treatment (MBT, 0.022– in slot; 3M Unitek,Monrovia,Calif).
(3) Patients with good general health (no significant medical history or drug use in the last month).
(4) Patients with permanent dentition.
(5) Patients without any periodontal diseases.
ExclusionCriteria
Details
(1) Patients on systemic consumption of antibiotics or anti-inflammatory medications taken during the period of the study.
(2) Patients with systemic diseases such as hormonal imbalances and bone diseases.
(3) Patients with periodontal diseases.
(4) Patients with carious or infiltrated restorations.
(5) Patients with fractured teeth or presence of erosion.
Method of Generating Random Sequence
Coin toss, Lottery, toss of dice, shuffling cards etc
Method of Concealment
Sequentially numbered, sealed, opaque envelopes
Blinding/Masking
Participant and Outcome Assessor Blinded
Primary Outcome
Outcome
TimePoints
Streptococcus mutans count
samples will be collected on the day of allocation of toothpaste group and next sample will be taken after a month
Secondary Outcome
Outcome
TimePoints
Plaque
samples will be collected on the day of allocation of toothpaste group and next sample will be taken after a month
Target Sample Size
Total Sample Size="44" Sample Size from India="44" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
N/A
Date of First Enrollment (India)
02/12/2019
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="0" Months="2" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
Publication will be done in an Indexed and peer - reviewed Journal.
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
need for the study:
The primary goal of dentistry is prevention of caries and periodontal disease.1 Great changes occur in the oral biofilm, resulting from the increase in retention niches of the orthodontic appliances.2-4 The patient might be predisposed to clinical and inflammatory alterations in the periodontal tissues, as the oral cavity is colonized by supragingival biofilm and bacteria that normally inhibit the gingival sulcus.5 When basic oral hygiene is poor, orthodontic appliances create areas of plaque stagnation, especially around brackets, bands, wires, and other attachments; this facilitates the development of white spot lesions.6 Levels of acidogenic bacteria , present in the plaque, notably Streptococcus mutans, are higher in orthodontic patients than non-orthodontic patients.7,8 This causes demineralization around the brackets and leads to white spot lesions. They are most prevalent around the cervical region of the bands in the posterior region, whereas in the anterior region, the lateral incisors in both arches, followed by the canines, are the most commonly affected.6
By interruption, reduction, or elimination of the microorganisms, the dental microbial film can be controlled.9 Dentifrices help in the removal of dental microbial biofilm and antimicrobial agents are excellent vehicles for the release of therapeutic substances.10 The most common way of controlling caries is removal of the dental microbial biofilm mechanically by tooth brushing with dentrifices.11 However, patients have difficulty in maintaining an acceptable level of oral hygiene, which is difficult to achieve by the mechanical method. Therefore, as supplements to traditional cleaning methods, antimicrobial agents are being incorporated into mouthwash solutions and dentrifices.12
Dental caries is strongly associated with Streptococcus mutans, while Lactobacilli are mainly associated with the progression of the carious lesion. Hence, the presence of these microorganisms at high levels indicates an increased risk of caries.13
The use of chlorhexidine digluconate toothpaste reduces the number of Streptococcus mutans dramatically which is highly sensitive to chlorhexidine in teenagers of a general population.13
The action of chlorhexidine mouthwashes has been reported in several studies.13 Nevertheless, there are no reports in the literature about chlorhexidine digluconate toothpaste in patients with fixed orthodontic appliances. Therefore, the aims of the study are to verify the antibacterial effect of the chlorhexidine digluconate toothpaste through clinical biofilm disclosure, and to quantify Streptococcus mutans in orthodontic patients.
null hypothesis:
There is no effect of chlorhexidine digluconate toothpaste and Colgate total toothpaste on Streptococcus mutans level around the orthodontic brackets.
research hypothesis:
There is a definite effect of chlorhexidine digluconate toothpaste and Colgate total toothpaste on Streptococcus mutans level around the orthodontic brackets.
source of the data:
Patients whose orthodontic treatment involves extraction of 4 first premolars will be recruited from the Department of Orthodontics and Dentofacial Orthopaedics of SDM College of Dental Sciences, Dharwad, Karnataka, India.
Informed consent will be obtained from the patients in the study. This research is designed as a prospective clinical study.
Sample size: The total sample comprises of 44 patients.
The inclusion criteria will be –
(1)Healthy patients (both genders) in the group of 14 to 25 years.
(3)Patients with good general health (no significant medical history or drug use in the last month).
(4)Patients with permanent dentition.
(5)Patients without any periodontal diseases.
The exclusion criteria will be -
(1)Patients on systemic consumption of antibiotics or anti-inflammatory medications taken during the period of the study.
(2)Patients with systemic diseases such as hormonal imbalances and bone diseases.
(3)Patients with periodontal diseases.
(4)Patients with carious or infiltrated restorations.
(5)Patients with fractured teeth or presence of erosion
method of collection of data:
The study is designed so that the sample size (44 patients) will be divided into two equal groups (group 1 and 2, each containing 22 volunteers) of both sexes, between ages of 14 and 30 years.
1. Clinical biofilm (plaque index) will be collected, from which the standard value for each patient will be obtained. The bacterial count will be performed.
2. For 30 days, group 1 will use chlorhexidine digluconate toothpaste, and group 2 will use the Colgate Total toothpaste.
3. After 30 days, the plaque index will be performed again, as well as the bacterial counts.
4.Participants will be instructed to brush their teeth in a method as shown by the researchers, twice a day, using the toothpaste and brush provided by the researchers.
5.The plaque index will be performed in accordance with the modified plaque index of Sillness and Loe14 with scores to determine the clinical disclosure of biofilm.
6.Plaque samples will be collected from the labial surfaces immediately surrounding the orthodontic brackets of the maxillary lateral incisors with a sterilized curette using a 4-pass technique as suggested by Pellegrini et al.15 Four passes, each along the tooth at the bracket interface at the gingival, mesial, distal, and occlusal aspects, will be used to prevent overloading of the instrument tip.
7.Samples will be analyzed using Mitis salivarius agar, which is the selective medium for the mutans group.
8. Rough surface colonies will be identified as Streptococcus mutans will be counted. The results will be expressed in colony forming units.
Statistical Methods:The data will be analyzed statistically with a significance level of 5%. The microbiologic evaluation will be analyzed for differences between control and treatment groups by means of two sample t test. The tests may vary depending upon the nature of results. The statistical significance level is established at P<0.05.list of references:
1.Santamaria M Jr, Petermann KD, Vedovello SA, Degan V, Lucato A, Franzini CM. Am J Orthod Dentofacial Orthop. 2014 Feb;145(2):198-202.
2. Diamantl-Kipioti A, Gusberti FA, Lang NP. Clinical and microbiological effects of fixed orthodontic appliances. J Clin Periodontol1987;14:326-33.
3. Atack NE, Sandy JR, Addy M. Periodontal and microbiological changes associated with the placement of orthodontic appliances.A review. J Periodontal 1996;67:78-85.
4.Gwinnett AJ, Ceen RF. Plaque distribution on bonded brackets: a scanning microscope study. Am J Orthod 1979;75:667-77.
5. Paster BJ, Boches SK, Galvin JL, Ericson RE, Lau CN, Levanos VA,et al. Bacterial diversity in human subgingival plaque. J Bacteriol 2001;183:3770-83.
6.Warat Sukontapatipark, Mohammad A. El-Agroudi, Nils J. Selliseth, Kirsten Thunold, Knut A. Selvig; Bacterial colonization associated with fixed orthodontic appliances. A scanning electron microscopy study, European Journal of Orthodontics, Volume 23, Issue 5, 1 October 2001, Pages 475–484.
7.Jose JE, Padmanabhan S, Chitharanjan AB. Systemic consumption of probiotic curd and use of probiotic toothpaste to reduce Streptococcus mutans in plaque around orthodontic brackets. Am J Orthod Dentofacial Orthop. 2013 Jul;144(1):67-72.
8.Bishara SE, Ostby AW. White spot lesions: formation, prevention and treatment. Semin Orthod 2008;14:174-82.
9. Emilson CG, Krasse B. Support for implication of the specific plaque hypothesis. Scand J Dent Res 1985;93:96-104.
10. Aguiar AA, Saliba NA. Toothbrushing with vegetable oil: a clinical and laboratorial analysis. Braz Oral Res 2004;18:168-73.
11.Frandsen A. Mechanical oral hygiene practices. In: Loe H,Kleinman DV, editors. Dental plaque control measures and oral hygiene practices. Oxford, Washington DC: IRL Press; 1986;93-116.
12. Owens J, Addy M, Faulkner J, Lockwood C, Adair R. A short-term clinical study design to investigate the chemical plaque inhibitory properties of mouthrinses when used as adjuncts to toothpastes: applied to chlorhexidine. J Clin Periodontol 1997;24:732-7.
13.Fredrik Lundström, Bo Krasse; Streptococcus mutans and lactobacilli frequency in orthodontic patients; the effect of chlorhexidine treatments, European Journal of Orthodontics, Volume 9, Issue 1, 1 January 1987, Pages 109–116.
14.J. Silness, H. Loe, Periodontal disease in pregnancy. ii. correlation between oral hygiene and periodontal condtion, Acta Odontol. Scand. 22 (1964) 121–135.
15.Pellegrini P, Sauerwein R, Finlayson T, McLeod J, Covell DA Jr,Maier T, et al. Plaque retention by self-ligating vs elastomeric orthodontic brackets: quantitative comparison of oral bacteria and detection with adenosine triphosphate-driven bioluminescence. Am J Orthop Dentofacial Orthop 2009;135:426.e1-9.