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A Comparison of Three Different Modalities in Improving Oral Hygiene

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ClinicalTrials.gov Identifier: NCT04386421
Recruitment Status : Recruiting
First Posted : May 13, 2020
Last Update Posted : November 6, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Umair Shoukat, Aga Khan University

Brief Summary:
The objective of the study is to compare effectiveness of OHI modalities a. verbal vs videographic material, b. Verbal vs plaque disclosing tablet and c. Videographic material vs plaque disclosing tablet over 3 months in adult orthodontic patients undergoing Fixed Appliance Treatment (FAT). Secondary objective of this study is to evaluate influence of three different modalities on patient cooperation and compliance towards orthodontic treatment.

Condition or disease Intervention/treatment Phase
Oral Disease Other: Video on oral hygeine instructions Drug: Plaque disclosing tablets Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Comparison of Three Different Modalities in Improving Oral Hygiene in Adult Orthodontic Patients - A Randomized Controlled Trial
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : August 30, 2021
Estimated Study Completion Date : August 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dental Health

Arm Intervention/treatment
Experimental: video group
Group A: A 3 minute video will be shown providing information regarding the care of the dentition during Fixed Appliance Treatment along with the importance of patient compliance and cooperation. The video will also be showing the consequences of poorly followed instructions such as gingivitis and white spot lesions. Participants in this group will also receive the same video graphic educational material through their Whats app once weekly for a total duration of 3 months.
Other: Video on oral hygeine instructions
A 3 minute video will be shown providing information regarding the care of the dentition during Fixed appliance treatment along with the importance of patient compliance and cooperation. The video will also be showing the consequences of poorly followed instructions such as gingivitis and white spot lesions.

Experimental: Plaque disclosing tablet
Group B: Plaque-disclosing tablets will be taken by patients on chair-side showing the location of the biofilm. The patients will be given plaque disclosing tablets to be used once weekly for 3 months to evaluate their oral hygiene at home. They will be given written information in the form of leaflets on importance of cooperation and compliance. Participants in this group will receive a reminder log fill, and tablets that are not used will be asked to return to the investigator by the participants to check the compliance.
Drug: Plaque disclosing tablets

Plaque disclosing tablets:

Product: 2-Tone Disclosing Tablets Young Dental Manufacturing 13705 Shoreline Court East Earth City, MO 63045 Composition: Flavor, SD Tutti Fruiti 1 %, D and C Red 1 % and FD and C Blue 1 %

Other Name: Plaque disclosing agent

No Intervention: Control. verbal instructions
Control Group C: Controls will be given only routine verbal OHI and will be briefed on the importance of cooperation and compliance at every orthodontic visit for a period of 3 months study. They will receive a reminder log that they will return at the end of the study to check compliance.



Primary Outcome Measures :
  1. Gingival Index (GI) [ Time Frame: 10 months ]

    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

  2. Bleeding Index (BI): [ Time Frame: 10 months ]

    0.Absence of bleeding after 30 seconds

    1. Bleeding observed after 30 seconds
    2. Immediate bleeding

  3. Orthodontic Plaque Index (OPI) [ Time Frame: 10 months ]

    0.No plaque deposits on the tooth surface surrounding the bracket base

    1. Plaque deposits on one tooth surface at the bracket base
    2. Plaque deposits on two tooth surfaces at the bracket base
    3. Plaque deposits on three tooth surfaces at the bracket base
    4. Plaque deposits on four tooth surfaces at the bracket base and/or gingival inflammation indicators (plaque deposits near the gingiva do not necessarily have to be present)


Secondary Outcome Measures :
  1. Orthodontic Patient Cooperation Scale (OPCS) [ Time Frame: 11 months ]
    1. This patient keeps appointments and is prompt. ( ) Always ( ) Frequently ( ) Sometimes ( ) Rarely ( ) Never
    2. This patient has distorted wires and/or loose bands. ( ) Always ( ) Frequently ( ) Sometimes ( ) Rarely ( ) Never
    3. This patient acts enthusiastic and interested in treatment. ( ) Always ( ) Frequently ( ) Sometimes ( ) Rarely ( ) Never
    4. This patient's behavior is sullen, hostile, belligerent, or rude. ( ) Always ( ) Frequently ( ) Sometimes ( ) Rarely ( ) Never
    5. This patient cooperates in the use of headgear and/or elastics. ( ) Always ( ) Frequently ( ) Sometimes ( ) Rarely ( ) Never
    6. This patient complains about treatment procedures. ( ) Always ( ) Frequently ( ) Sometimes ( ) Rarely ( ) Never
    7. This patient demonstrates excellent oral hygiene. ( ) Always ( ) Frequently ( ) Sometimes ( ) Rarely ( ) Never
    8. This patient complains about wear braces. ( ) Always ( ) Frequently ( ) Sometimes ( ) Rarely ( ) Never

  2. Clinical compliance evaluation form (CCE) [ Time Frame: 11 ]

    Oral Hygiene:

    Plaque:

    RU6 RU1 LU6 LU1 RL6 LL6 None 4 4 4 4 4 4 Below bracket 3 3 3 3 3 3 On and below bracket 2 2 2 2 2 2 Above and below bracket 1 1 1 1 1 1

    Appointment Punctuality:

    On time or before 25 15-30 mins late 20 More than 30 mins late 15 Change Appointments in 24hrs 10 No Show 0

    Appliance Wear:

    Time HG Elastics 90-100% 25 25 80-90% 21 21 70-80% 18 18 60-70% 15 15 50-60% 12 12 40-50% 09 09 30-40% 06 06 20-30% 03 03 10-20% 0 0

    Appliance Maintenance:

    No breakage or bend in archwire 25 No breakage but mild bends in archwire 15 Moderate bends in archwire 10 Loose bands 5 Broken bracket or lose appliance 0 Scores Oral Hygiene:________________________ Appointment Punctuality:___________________ Appliance wear:________________________ Appliance maintenance:_________________________




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Ages Eligible for Study:   18 Years to 36 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing orthodontic treatment with fixed appliance (FAT) since 6 months
  • Patients of both gender, aged 18-36 years. As, chances of declining periodontal status increases after 36 years of age.
  • Patients having an Andriod phone with Whatsapp application installed..
  • Patients with all bonded teeth mesial to the first molars.
  • Healthy patients with no co-morbids such as rheumatic fever, blood dyscrasias, congenital heart disease or diabetes mellitus.
  • Subjects with gingivitis as assessed by bleeding index (score ≤1), orthodontic plaque index (score ≤2) and gingival index (score ≤1) as assessed by Williams -Probe.
  • All patients who will give consent for participation.

Exclusion Criteria:

  • Subjects with clinical attachment loss of greater than 2 mm on two sites.
  • Pregnant or lactating females.
  • Subjects with removable/fixed dental prosthesis or banded teeth.
  • History of surgical or nonsurgical periodontal therapy in the last 6 months.
  • Current smokers or smokeless tobacco users. (According to glossary of Centers for Disease Control and Prevention, an adult who has smoked 100 cigarettes in his or her lifetime and who currently smokes cigarettes is considered to be current smoker).
  • Patients having systemic reasons for periodontal diseases for example uncontrolled diabetes, hypertension.

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): NCT04386421


Contacts
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Contact: UMAIR SHOUKAT ALI ARAIN, BDS +92-3362043231 ext 6467 umair.shoukat@aku.edu

Locations
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Pakistan
Aga Khan University Recruiting
Karachi, Sindh, Pakistan
Contact: Umair Shoukat Ali       umair.shoukat@aku.edu   
Sponsors and Collaborators
Aga Khan University
Investigators
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Principal Investigator: Rashna Hoshang Sukhia, BDS, FCPS Aga Khan University and Hospital
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Responsible Party: Dr. Umair Shoukat, Co-investigator, Aga Khan University
ClinicalTrials.gov Identifier: NCT04386421    
Other Study ID Numbers: 2020-1506-10214.
First Posted: May 13, 2020    Key Record Dates
Last Update Posted: November 6, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Umair Shoukat, Aga Khan University:
fixed orthodonitcs treatment
Adult orthodontics
Additional relevant MeSH terms:
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Mouth Diseases
Stomatognathic Diseases