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Trial record 70 of 662 for:    SMS

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

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ClinicalTrials.gov Identifier: NCT03508999
Recruitment Status : Completed
First Posted : April 26, 2018
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
Hafiz Taha Mahmood, Aga Khan University

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.


Condition or disease Intervention/treatment Phase
Gingivitis Drug: Metronidazole gel Other: SMS text reminder Other: Placebo gel Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Metronidazole Gel and Mobile Telephone Short- Message Service Reminders on Gingivitis in Orthodontic Patients: A Randomized Controlled Trial
Actual Study Start Date : May 23, 2018
Actual Primary Completion Date : November 30, 2018
Actual Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Metronidazole Gel
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
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.
Other Name: Anaerobic gel

SMS Text Reminder
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
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.
Other Name: Reminder

Placebo Comparator: Placebo
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
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.




Primary Outcome Measures :
  1. Improvement of Bleeding Index [ Time Frame: Improvement in Bleeding Index Scores at 4 Weeks ]

    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

  2. Improvement in Gingival index [ Time Frame: Improvement in Gingival Index Scores at 4 Weeks ]

    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

  3. Improvement of Orthodontic Plaque Index [ Time Frame: Improvement in Orthodontic Plaque Index Scores at 4 Weeks ]

    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)



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03508999


Locations
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Pakistan
Aga Khan University Hospital
Karachi, Sindh, Pakistan, 74800
Sponsors and Collaborators
Aga Khan University
Investigators
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Principal Investigator: Mubassar Fida, BDS, FCPS Consultant

Publications:

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Responsible Party: Hafiz Taha Mahmood, Principal Investigator, Aga Khan University
ClinicalTrials.gov Identifier: NCT03508999     History of Changes
Other Study ID Numbers: Gingivitis_Orthodontics
First Posted: April 26, 2018    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Gingivitis
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Metronidazole
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents