Efficacy of Miswak in Oral Hygiene Maintenance

NCT04561960 | Completed Phase 4

• 1 other identifier: FRP/2020/264
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Plaque

Keywords

miswak; siwak; S. persica; chew stick

Outcome Measures

Primary Outcomes (6)

• Base line Plaque Score

  Silness-Löe Index: #16, #12, #24, #36, #32, #44Missing teeth are not substituted. 0-3, 0 being absent from plaque

  Baseline

• 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

  One week

• 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

  Two weeks

• 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

  Baseline

• 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

  One week

• 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

  Two weeks

Secondary Outcomes (1)

• Presence of White spot lesions

  Two weeks

Study Arms (3)

Control

ACTIVE COMPARATOR

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

Drug: Fluoride toothpaste; Device: Toothbrush

Miswak

EXPERIMENTAL

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

Device: Miswak Stick

Miswak Paste

EXPERIMENTAL

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

Drug: Toothpaste Product; Device: Toothbrush

Interventions

Fluoride toothpaste DRUG

Fluoridated paste containing 1450ppm NaF

Control

Toothpaste Product DRUG

Non Fluoridated toothpaste with extract of miswak ( Dabur, miswak tooth paste)

Miswak Paste

Toothbrush DEVICE

Colgate classic clean Soft bristled toothbrushes, 19.05 x 1.27 x 1.91 cm

Control; Miswak Paste

Miswak Stick DEVICE

A miswak stick of 15 cm length

Miswak

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riyadh Elm University: lead

Study Sites (1)

Riyadh Elm University

Riyadh, Saudi Arabia

Location

Related Publications (11)

• 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.

  PMID: 3460112 RESULT

• Elvin-Lewis M. The therapeutic potential of plants used in dental folk medicine. Odontostomatol Trop. 1982 Sep;5(3):107-17. No abstract available.

  PMID: 6962424 RESULT

• 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.

  PMID: 22628969 RESULT

• 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.

  PMID: 15560804 RESULT

• 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.

  PMID: 23960531 RESULT

• 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.

  PMID: 25935172 RESULT

• 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.

  RESULT

• Norton MR, Addy M. Chewing sticks versus toothbrushes in West Africa. A pilot study. Clin Prev Dent. 1989 May-Jun;11(3):11-3.

  PMID: 2605858 RESULT

• 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.

  PMID: 25077082 RESULT

• World Health Organization. (1997). Oral health surveys: basic methods, 4th ed. World Health Organization

  RESULT

• 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.

  PMID: 12790510 RESULT

MeSH Terms

Conditions

Dental Plaque

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Omar Alkadhi, MSc

  Head of IRB, REU

  STUDY CHAIR

• Sarah S Aburaisi, MSc

  Assistant Professor, prothetic dental department, REU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 16, 2020
• First Posted: September 24, 2020
• Study Start: September 30, 2020
• Primary Completion: December 10, 2020
• Study Completion: December 30, 2020
• Last Updated: March 10, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)