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Efficacy of Miswak in Oral Hygiene Maintenance

Primary Purpose

Dental Plaque

Status
Completed
Phase
Phase 4
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Fluoride toothpaste
Toothpaste Product
Toothbrush
Miswak Stick
Sponsored by
Riyadh Elm University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Plaque focused on measuring miswak, siwak, S. persica, chew stick

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy adults
  • Able to perform their own oral hygiene
  • Dental students

Exclusion Criteria:

  • Active Dental Caries
  • Uncontrolled chronic medical conditions
  • History of drug and/or treatment that reduces salivary flow
  • Currently undergoing orthodontic treatment
  • Missing index teeth #16, #12, #24, #36, #32, #44

Sites / Locations

  • Riyadh Elm University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Control

Miswak

Miswak Paste

Arm Description

Participants will be trained to perform oral hygiene using the modified bass technique. The participants will be asked to brush their teeth twice daily using a manual tooth brush and fluoridated toothpaste containing 1450ppm of fluoride

Participants will be trained to chew and condition a miswak stick Participants will be asked to use the miswak stick twice daily

Participants will be trained to perform oral hygiene using the modified bass technique. The participants will be asked to brush their teeth twice daily using a manual tooth brush a non-fluoridated toothpaste containing miswak extract

Outcomes

Primary Outcome Measures

Base line Plaque Score
Silness-Löe Index: #16, #12, #24, #36, #32, #44Missing teeth are not substituted. 0-3, 0 being absent from plaque
Plaque Score change at 1 week
Silness-Löe Index: #16, #12, #24, #36, #32, #44Missing teeth are not substituted. 0-3, 0 being absent from plaque
Plaque Score change at 2 weeks
Silness-Löe Index: #16, #12, #24, #36, #32, #44Missing teeth are not substituted. 0-3, 0 being absent from plaque
Baseline Bleeding Score
Gingival Index (Loe & Silness 1963): #16, #12, #24, #36, #32, #44Missing teeth are not substituted. 0-4 . 0 being absent from inflammation
Bleeding Score change at 1 week
Gingival Index (Loe & Silness 1963): #16, #12, #24, #36, #32, #44Missing teeth are not substituted. 0-4 . 0 being absent from inflammation
Bleeding Score change at 2 weeks
Gingival Index (Loe & Silness 1963): #16, #12, #24, #36, #32, #44Missing teeth are not substituted. 0-4 . 0 being absent from inflammation

Secondary Outcome Measures

Presence of White spot lesions
Visual Initial signs of dental caries

Full Information

First Posted
September 16, 2020
Last Updated
March 8, 2021
Sponsor
Riyadh Elm University
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1. Study Identification

Unique Protocol Identification Number
NCT04561960
Brief Title
Efficacy of Miswak in Oral Hygiene Maintenance
Official Title
Efficacy of Miswak When Compared to Fluoridated Toothpaste for the Maintenance of Oral Hygiene in Young Adults
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
September 30, 2020 (Actual)
Primary Completion Date
December 10, 2020 (Actual)
Study Completion Date
December 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Riyadh Elm University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Miswak has been recommended by world health organization for oral hygiene because of its availability, beneficial effect and affordability. The popularity of Miswak in Arab countries has meant that there have been several studies that have confirmed the ability of miswak to provide effective mechanical and chemical cleansing when used as an adjunct to other oral hygiene aids. Fluoridated tooth paste and manual tooth brushes have been the standard of clinical preventive dental care for over 50 years.However, the objection to the use of fluorides by some parents has meant that these pastes are not universally accepted. There are several non-fluoridated pastes available in the market that include the extract of miswak. There are few studies that have compared these pastes to fluoridated pastes and to miswak as a stand alone agents. Miswak has been recommended by world health organization in 1987 for oral hygiene because of its availability, beneficial effect and affordability. It has been stated that "Several clinical studies have confirmed that the mechanical and chemical cleansing efficiency of miswak chewing sticks are equal and at times greater than that of the toothbrush" this was mentioned and reviewed that it is in fact right but only when used in a regular constant matter with a proper and effective way of plaque removal. This study aims to use a cross over model to study the effectiveness of miswak as a stand alone agent in maintaining oral hygiene in young adults and compare it miswak containing toothpastes and fluoridated toothpastes when used with a manual tooth brush.
Detailed Description
Oral hygiene is the key of maintaining human's mouth at a state of equilibrium and free of diseases (e.g. cavities, dental decay, gingivitis, halitosis). Poor oral hygiene can significantly affect the quality of life and has a considerable influence on diet, sleeping, social communication, psychological status, and by being less productive at work. Therefore, oral hygiene is essential for general health and well-being. Oral hygiene measures include toothbrush which is the most commonly used method for plaque control. However, miswak is a commonly used method in many developing countries. Miswak has a widespread among religious, rural and developing countries for its spiritual impact since the use of miswak was advised by prophet mohammed (peace be upon him) centuries ago as he said "had I not thought it difficult for my ummah, I would have commanded them to use miswak before every prayer". Miswak has been recommended by world health organization for oral hygiene because of its availability, beneficial effect and affordability. Previous chemical examinations changed our idea in Miswak which showed us that miswak sticks contain natural ingredients which benefits our oral health. Miswak extracts appear to have different beneficial biological properties like anti-bacterial and anti-fungal effects which will play a high role in oral hygiene measures. Multiple researches suggested that miswak has anti-cariogenic effects. several studies concluded that Chewing sticks (miswak) has revealed parallel and at times greater mechanical and chemical cleansing of oral tissues as compared to a toothbrush. The popularity of Miswak in Arab countries has meant that there have been several studies that have confirmed the ability of miswak to provide effective mechanical and chemical cleansing when used as an adjunct to other oral hygiene aids. In a previous study found that the periodontal health of miswak users was better than the periodontal health of manual toothbrush users, also it was concluded that miswak is more effective than tooth brushing for reducing plaque and gingivitis when preceded by professional instruction regarding its correct application. Another research reported the opposite thing, Punit Patel and S. Shruthi studied the clinical effects of miswak as an adjunct to tooth brushing on gingivitis clearly and they find that the indication of miswak cannot replace the toothbrush, but can be used an adjunct to toothbrush, utilizing the mechanical efficacy of toothbrush and chemical effects of miswak. However, it was concluded that "The use of S. persica miswak alone or in combination with conventional toothbrushes, when performed judiciously, will result in superior oral health and hygiene." Fluoridated tooth paste and manual tooth brushes have been the standard of clinical preventive dental care for over 50 years. However, the objection to the use of fluorides by some parents has meant that these pastes are not universally accepted. There is a lot of controversy whether the miswak alone can be used for effective plaque removal and good gingival health or should it be only used as an adjunct to tooth brushing. In this study we will determine whether the miswak can be used as the chief tool in oral health rather than an adjunct to tooth brushing. We will also determine whether toothpaste using the miswak extract can be as effective as the normal fluoridated toothpaste.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Plaque
Keywords
miswak, siwak, S. persica, chew stick

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
Participants will be trained to perform oral hygiene using the modified bass technique. The participants will be asked to brush their teeth twice daily using a manual tooth brush and fluoridated toothpaste containing 1450ppm of fluoride
Arm Title
Miswak
Arm Type
Experimental
Arm Description
Participants will be trained to chew and condition a miswak stick Participants will be asked to use the miswak stick twice daily
Arm Title
Miswak Paste
Arm Type
Experimental
Arm Description
Participants will be trained to perform oral hygiene using the modified bass technique. The participants will be asked to brush their teeth twice daily using a manual tooth brush a non-fluoridated toothpaste containing miswak extract
Intervention Type
Drug
Intervention Name(s)
Fluoride toothpaste
Intervention Description
Fluoridated paste containing 1450ppm NaF
Intervention Type
Drug
Intervention Name(s)
Toothpaste Product
Intervention Description
Non Fluoridated toothpaste with extract of miswak ( Dabur, miswak tooth paste)
Intervention Type
Device
Intervention Name(s)
Toothbrush
Intervention Description
Colgate classic clean Soft bristled toothbrushes, 19.05 x 1.27 x 1.91 cm
Intervention Type
Device
Intervention Name(s)
Miswak Stick
Intervention Description
A miswak stick of 15 cm length
Primary Outcome Measure Information:
Title
Base line Plaque Score
Description
Silness-Löe Index: #16, #12, #24, #36, #32, #44Missing teeth are not substituted. 0-3, 0 being absent from plaque
Time Frame
Baseline
Title
Plaque Score change at 1 week
Description
Silness-Löe Index: #16, #12, #24, #36, #32, #44Missing teeth are not substituted. 0-3, 0 being absent from plaque
Time Frame
One week
Title
Plaque Score change at 2 weeks
Description
Silness-Löe Index: #16, #12, #24, #36, #32, #44Missing teeth are not substituted. 0-3, 0 being absent from plaque
Time Frame
Two weeks
Title
Baseline Bleeding Score
Description
Gingival Index (Loe & Silness 1963): #16, #12, #24, #36, #32, #44Missing teeth are not substituted. 0-4 . 0 being absent from inflammation
Time Frame
Baseline
Title
Bleeding Score change at 1 week
Description
Gingival Index (Loe & Silness 1963): #16, #12, #24, #36, #32, #44Missing teeth are not substituted. 0-4 . 0 being absent from inflammation
Time Frame
One week
Title
Bleeding Score change at 2 weeks
Description
Gingival Index (Loe & Silness 1963): #16, #12, #24, #36, #32, #44Missing teeth are not substituted. 0-4 . 0 being absent from inflammation
Time Frame
Two weeks
Secondary Outcome Measure Information:
Title
Presence of White spot lesions
Description
Visual Initial signs of dental caries
Time Frame
Two weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy adults Able to perform their own oral hygiene Dental students Exclusion Criteria: Active Dental Caries Uncontrolled chronic medical conditions History of drug and/or treatment that reduces salivary flow Currently undergoing orthodontic treatment Missing index teeth #16, #12, #24, #36, #32, #44
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Omar Alkadhi, MSc
Organizational Affiliation
Head of IRB, REU
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sarah S Aburaisi, MSc
Organizational Affiliation
Assistant Professor, prothetic dental department, REU
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riyadh Elm University
City
Riyadh
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
3460112
Citation
Hawkins BF, Kohout FJ, Lainson PA, Heckert A. Duration of toothbrushing for effective plaque control. Quintessence Int. 1986 Jun;17(6):361-5. No abstract available.
Results Reference
result
PubMed Identifier
6962424
Citation
Elvin-Lewis M. The therapeutic potential of plants used in dental folk medicine. Odontostomatol Trop. 1982 Sep;5(3):107-17. No abstract available.
Results Reference
result
PubMed Identifier
22628969
Citation
Patel PV, Shruthi S, Kumar S. Clinical effect of miswak as an adjunct to tooth brushing on gingivitis. J Indian Soc Periodontol. 2012 Jan;16(1):84-8. doi: 10.4103/0972-124X.94611.
Results Reference
result
PubMed Identifier
15560804
Citation
Al-Otaibi M, Al-Harthy M, Gustafsson A, Johansson A, Claesson R, Angmar-Mansson B. Subgingival plaque microbiota in Saudi Arabians after use of miswak chewing stick and toothbrush. J Clin Periodontol. 2004 Dec;31(12):1048-53. doi: 10.1111/j.1600-051X.2004.00618.x.
Results Reference
result
PubMed Identifier
23960531
Citation
Halawany HS. A review on miswak (Salvadora persica) and its effect on various aspects of oral health. Saudi Dent J. 2012 Apr;24(2):63-9. doi: 10.1016/j.sdentj.2011.12.004. Epub 2012 Jan 28.
Results Reference
result
PubMed Identifier
25935172
Citation
Haque MM, Alsareii SA. A review of the therapeutic effects of using miswak (Salvadora Persica) on oral health. Saudi Med J. 2015 May;36(5):530-43. doi: 10.15537/smj.2015.5.10785.
Results Reference
result
Citation
Devi, Aruna M.; Hampannavar, Pooja; Radha, G.; Kadanakuppe, Sushi; Nagashree, S. R.; Kumar, Vinod A. (2011) Comparing the Efficacy of Plaque Removal between Salvadora persica (Miswak) and Manual Toothbrush in 12 to 15 Years School Children. World Journal of Dentistry, 2(1), pp. 29-33.
Results Reference
result
PubMed Identifier
2605858
Citation
Norton MR, Addy M. Chewing sticks versus toothbrushes in West Africa. A pilot study. Clin Prev Dent. 1989 May-Jun;11(3):11-3.
Results Reference
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PubMed Identifier
25077082
Citation
Malik AS, Shaukat MS, Qureshi AA, Abdur R. Comparative effectiveness of chewing stick and toothbrush: a randomized clinical trial. N Am J Med Sci. 2014 Jul;6(7):333-7. doi: 10.4103/1947-2714.136916.
Results Reference
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Citation
World Health Organization. (1997). Oral health surveys: basic methods, 4th ed. World Health Organization
Results Reference
result
PubMed Identifier
12790510
Citation
Darout IA, Skaug N, Albandar JM. Subgingival microbiota levels and their associations with periodontal status at the sampled sites in an adult Sudanese population using miswak or toothbrush regularly. Acta Odontol Scand. 2003 Apr;61(2):115-22. doi: 10.1080/00016350310002784.
Results Reference
result

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Efficacy of Miswak in Oral Hygiene Maintenance

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