Effectiveness of Metronidazole Gel and Mobile SMS Reminders on Gingivitis in Orthodontic Patients

NCT03508999 | Completed Phase 4 DMC

• 1 other identifier: Gingivitis_Orthodontics
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

A rapid deterioration in oral hygiene occur after bonding of orthodontic appliances. Zachrisson and Zachrisson have reported that even after maintaining excellent oral hygiene, patients usually experience mild to moderate gingivitis within 1-2 months after orthodontic appliance placement. Slutzkey and Levin have reported a prevalence of 72 % gingivitis in orthodontic patients. The difficulty in maintenance of oral hygiene and inefficient removal of supragingival plaque due to the appliances lead to development of gingivitis and hyperplasia. Tooth brush access to the buccal surface of the teeth becomes problematic and predisposes plaque buildup around the brackets. Investigators are now focusing on the development of localized drug delivery systems that can allow maximum concentration on the target site, thus minimizing the potential systemic effects. Metronidazole has been used by several researchers due to its selective antimicrobial activity against the obligate anaerobes. The topical administration in gel form has several advantages. Miani et al concluded that the use of metronidazole gel significantly reduces the total bacterial count in the gingival crevicular fluid. In medicine and dentistry, active mobile telephone short-message service (SMS) reminders have been used to improve patient compliance and positive behavior changes. A study conducted by Epprighta et al have reported the effectiveness of SMS reminder in orthodontic patients. They have reported significantly lower bleeding, gingival and plaque indices scores in SMS reminder group as compared to control. Rationale: The application of metronidazole gel is effective in management of gingivitis in patients undergoing orthodontic therapy. Additionally, the constant reminder therapy at weekly interval would also lead to improvement in the oral hygiene. According to pertinent literature survey, none of the study has been conducted to compare the effectiveness of SMS reminders and use of anaerobic gel to reduce gingival inflammation. Null Hypothesis: Application of 0.8% metronidazole gel and mobile telephone short-message service oral hygiene reminders is equally effective in reducing the gingival inflammation in orthodontic patients with gingivitis as compared to control group. Objective: The objectives of the study will be to assess the use of topical gel or mobile telephone short-message service oral hygiene reminders can reduce gingivitis in orthodontic patients as compared to control group.

Conditions

Gingivitis

Outcome Measures

Primary Outcomes (3)

• Improvement of Bleeding Index

  Improvement in Bleeding Index Scores In Orthodontic Patients, Change from Baseline in Index at 4 weeks. All the measurements at the baseline (To) and follow ups (T1) will be recorded by the investigator on separate To and T1 sheets. Six standard sites on incisors, canines and premolars have been used in this study as study sites. The study sites will be six proximal-buccal line angles on the following teeth: right maxillary second premolar, mesiobuccal line angle; right maxillary canine, distobuccal line angle; left maxillary central incisor, distolabial line angle; right mandibular central incisor, distolabial line angle; left mandibular canine, distobuccal line angle; and left mandibular second premolar, mesiobuccal line angle. If a study tooth was missing, the corresponding tooth on the contralateral side will be examined. 0\. Absence of bleeding after 30 seconds 1. Bleeding observed after 30 seconds 2. Immediate bleeding

  Improvement in Bleeding Index Scores at 4 Weeks

• Improvement in Gingival index

  Improvement in Gingival Index Scores In Orthodontic Patients, Change from Baseline in Index at 4 weeks. All the measurements at the baseline (To) and follow ups (T1) will be recorded by the investigator on separate To and T1 sheets. Six standard sites on incisors, canines and premolars have been used in this study as study sites (same as above). 0\. No inflammation. 1. Mild inflammation, slight change in color, slight edema, no bleeding on probing. 2. Moderate inflammation, moderate glazing, redness, bleeding on probing. 3. Severe inflammation, marked redness and hypertrophy, ulceration, tendency to spontaneous bleeding

  Improvement in Gingival Index Scores at 4 Weeks

• Improvement of Orthodontic Plaque Index

  Improvement in Orthodontic Plaque Index Scores In Orthodontic Patients, Change from Baseline in Index at 4 weeks. All the measurements at the baseline (To) and follow ups (T1) will be recorded by the investigator on separate To and T1 sheets. Six standard sites on incisors, canines and premolars have been used in this study as study sites (same as above) and the condition of adjacent marginal gingiva by staining the teeth with plaque disclosing solution will be assessed. 0\. No plaque deposits on the tooth surfaces surrounding the bracket base 1. Plaque deposits on one tooth surface at the bracket base 2. Plaque deposits on two tooth surface at the bracket base 3. Plaque deposits on three tooth surface at the bracket base 4. Plaque deposits on four tooth surface at the bracket base and/or gingival inflammation indicators (plaque deposits near the gingiva do not necessarily have to be present)

  Improvement in Orthodontic Plaque Index Scores at 4 Weeks

Study Arms (3)

Metronidazole Gel

EXPERIMENTAL

Group A subjects will be given standard oral hygiene instructions on the visit with a standard 0.8 % metronidazole gel instructed to apply topically on the marginal gingiva for the next 4 weeks, twice a day for 30 minutes, after morning and evening tooth brushing.

Drug: Metronidazole gel

SMS Text Reminder

OTHER

Subjects will be provided biweekly reminder via SMS in the form of text message reinforcing oral hygiene. Additionally, patients will be given standard oral hygiene instructions on the visit with a placebo gel topically instructed to apply on the marginal gingiva for the next 4 weeks, twice a day for 30 minutes, after morning and evening tooth brushing.

Other: SMS text reminder

Placebo

PLACEBO COMPARATOR

Group C will be subjects will be given standard oral hygiene instructions on the visit with a placebo gel topically instructed to apply on the marginal gingiva for the next 4 weeks, twice a day for 30 minutes, after morning and evening tooth brushing.

Other: Placebo gel

Interventions

Metronidazole gel DRUG

The application of metronidazole gel is effective in the management of gingivitis in patients undergoing orthodontic therapy. Additionally, the constant reminder therapy at weekly interval would also lead to improvement in the oral hygiene.16 According to pertinent literature survey, none of the study has been conducted to compare the effectiveness of SMS reminders and use of anaerobic gel to reduce gingival inflammation.

Also known as: Anaerobic gel

Metronidazole Gel

SMS text reminder OTHER

Subjects will be provided biweekly reminder via 'SMS text reminder' in the form of text message reinforcing oral hygiene. Additionally, patients will be given standard oral hygiene instructions on the visit with a placebo gel topically instructed to apply on the marginal gingiva for the next 4 weeks, twice a day for 30 minutes, after morning and evening tooth brushing.

Also known as: Reminder

SMS Text Reminder

Placebo gel OTHER

Group C will be subjects will be given standard oral hygiene instructions on the visit with a placebo gel topically instructed to apply on the marginal gingiva for the next 4 weeks, twice a day for 30 minutes, after morning and evening tooth brushing.

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients undergoing orthodontic treatment with fixed appliance since 6 months
• Patients with all bonded teeth mesial to the first molars and not adjacent to a banded tooth
• Systematically healthy patient with no co-morbid such as rheumatic fever, blood dyscrasias, congenital heart disease or diabetes mellitus
• Subjects with gingivitis as assessed by bleeding index (score =2), orthodontic plaque index (score ≥ 2) and gingival index (score ≥ 2) as assessed by Williams Probe
• All patients who sign the inform consent will be included in the study

You may not qualify if:

• Subjects with clinical attachment loss of greater than 2 mm on two sites
• Pregnant or lactating females
• Subjects with removal or fixed dental prosthesis, teeth with banding used for attachment
• History of surgical or nonsurgical periodontal therapy in the last 6 months
• Use of antibiotic or anti-inflammatory in the last 30 days confirmed by patient's history
• Habit of smoking or use of smokeless tobacco
• Allergic to Metronidazole according to patient history

Sponsors & Collaborators

• Aga Khan University: lead

Study Sites (1)

Aga Khan University Hospital

Karachi, Sindh, 74800, Pakistan

Location

Related Publications (20)

• Al-Jewair TS, Suri S, Tompson BD. Predictors of adolescent compliance with oral hygiene instructions during two-arch multibracket fixed orthodontic treatment. Angle Orthod. 2011 May;81(3):525-31. doi: 10.2319/092010-547.1. Epub 2011 Feb 9.

  PMID: 21306222 BACKGROUND

• Timmerman MF, van der Weijden GA. Risk factors for periodontitis. Int J Dent Hyg. 2006 Feb;4(1):2-7. doi: 10.1111/j.1601-5037.2006.00168.x.

  PMID: 16451433 BACKGROUND

• Zachrisson S, Zachrisson BU. Gingival condition associated with orthodontic treatment. Angle Orthod. 1972 Jan;42(1):26-34. doi: 10.1043/0003-3219(1972)0422.0.CO;2. No abstract available.

  PMID: 4500561 BACKGROUND

• Slutzkey S, Levin L. Gingival recession in young adults: occurrence, severity, and relationship to past orthodontic treatment and oral piercing. Am J Orthod Dentofacial Orthop. 2008 Nov;134(5):652-6. doi: 10.1016/j.ajodo.2007.02.054.

  PMID: 18984397 BACKGROUND

• O'Reilly MM, Featherstone JD. Demineralization and remineralization around orthodontic appliances: an in vivo study. Am J Orthod Dentofacial Orthop. 1987 Jul;92(1):33-40. doi: 10.1016/0889-5406(87)90293-9.

  PMID: 3300270 BACKGROUND

• Lundstrom F, Krasse B. Caries incidence in orthodontic patients with high levels of Streptococcus mutans. Eur J Orthod. 1987 May;9(2):117-21. doi: 10.1093/ejo/9.2.117. No abstract available.

  PMID: 3472889 BACKGROUND

• Alexander SA. The effect of fixed and functional appliances on enamel decalcifications in early Class II treatment. Am J Orthod Dentofacial Orthop. 1993 Jan;103(1):45-7. doi: 10.1016/0889-5406(93)70103-U.

  PMID: 8422030 BACKGROUND

• Ainamo J. Control of plaque by chemical agents. J Clin Periodontol. 1977 Dec;4(5):23-35. doi: 10.1111/j.1600-051x.1977.tb00049.x. No abstract available.

  PMID: 275277 BACKGROUND

• Hanes PJ, Purvis JP. Local anti-infective therapy: pharmacological agents. A systematic review. Ann Periodontol. 2003 Dec;8(1):79-98. doi: 10.1902/annals.2003.8.1.79.

  PMID: 14971250 BACKGROUND

• Slots J, Ting M. Systemic antibiotics in the treatment of periodontal disease. Periodontol 2000. 2002;28:106-76. doi: 10.1034/j.1600-0757.2002.280106.x. No abstract available.

  PMID: 12013339 BACKGROUND

• Loesche WJ. Antimicrobials in dentistry: with knowledge comes responsibility. J Dent Res. 1996 Jul;75(7):1432-3. doi: 10.1177/00220345960750070101. No abstract available.

  PMID: 8876593 BACKGROUND

• Pavia M, Nobile CG, Bianco A, Angelillo IF. Meta-analysis of local metronidazole in the treatment of chronic periodontitis. J Periodontol. 2004 Jun;75(6):830-8. doi: 10.1902/jop.2004.75.6.830.

  PMID: 15295949 BACKGROUND

• Miani PK, do Nascimento C, Sato S, Filho AV, da Fonseca MJ, Pedrazzi V. In vivo evaluation of a metronidazole-containing gel for the adjuvant treatment of chronic periodontitis: preliminary results. Eur J Clin Microbiol Infect Dis. 2012 Jul;31(7):1611-8. doi: 10.1007/s10096-011-1484-7. Epub 2011 Dec 6.

  PMID: 22138847 BACKGROUND

• Fjeldsoe BS, Marshall AL, Miller YD. Behavior change interventions delivered by mobile telephone short-message service. Am J Prev Med. 2009 Feb;36(2):165-73. doi: 10.1016/j.amepre.2008.09.040.

  PMID: 19135907 BACKGROUND

• Eppright M, Shroff B, Best AM, Barcoma E, Lindauer SJ. Influence of active reminders on oral hygiene compliance in orthodontic patients. Angle Orthod. 2014 Mar;84(2):208-13. doi: 10.2319/062813-481.1. Epub 2013 Sep 12.

  PMID: 24028316 BACKGROUND

• Gettinger G, Patters MR, Testa MA, Loe H, Anerud A, Boysen H, Robertson PB. The use of six selected teeth in population measures of periodontal status. J Periodontol. 1983 Mar;54(3):155-9. doi: 10.1902/jop.1983.54.3.155.

  PMID: 6573472 BACKGROUND

• Saxton CA, van der Ouderaa FJ. The effect of a dentifrice containing zinc citrate and Triclosan on developing gingivitis. J Periodontal Res. 1989 Jan;24(1):75-80. doi: 10.1111/j.1600-0765.1989.tb00860.x.

  PMID: 2524573 BACKGROUND

• Loe H. The Gingival Index, the Plaque Index and the Retention Index Systems. J Periodontol. 1967 Nov-Dec;38(6):Suppl:610-6. doi: 10.1902/jop.1967.38.6.610. No abstract available.

  PMID: 5237684 BACKGROUND

• Beberhold K, Sachse-Kulp A, Schwestka-Polly R, Hornecker E, Ziebolz D. The Orthodontic Plaque Index: an oral hygiene index for patients with multibracket appliances. Orthodontics (Chic.). 2012;13(1):94-9.

  PMID: 22567620 BACKGROUND

• Martin BJ, Campbell PM, Rees TD, Buschang PH. A randomized controlled trial evaluating antioxidant-essential oil gel as a treatment for gingivitis in orthodontic patients. Angle Orthod. 2016 May;86(3):407-12. doi: 10.2319/041515-251.1. Epub 2015 Aug 17.

  PMID: 26280662 BACKGROUND

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Mubassar Fida, BDS, FCPS

  Consultant

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 29, 2018
• First Posted: April 26, 2018
• Study Start: May 23, 2018
• Primary Completion: November 30, 2018
• Study Completion: November 30, 2018
• Last Updated: December 4, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)