comparison of two toothpastes on microorganisms in orthodontic patients
- Conditions
- No significant medical history
- Registration Number
- CTRI/2019/11/022140
- Lead Sponsor
- Dr Deeksha S Innanje
- Brief Summary
need for the study:
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|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.11However, 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:
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|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:
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|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.
(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.
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| 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:
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|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:
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|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.
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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.
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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.
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- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 44
- (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.
- (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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method Plaque samples will be collected on the day of allocation of toothpaste group and next sample will be taken after a month
Trial Locations
- Locations (1)
S D M College of Dental Sciences and Hospital
🇮🇳Dharwad, KARNATAKA, India
S D M College of Dental Sciences and Hospital🇮🇳Dharwad, KARNATAKA, IndiaDr Deeksha S InnanjePrincipal investigator8762722888deekshainnanje@gmail.com