Effectiveness of Salvadora Persica Miswak in Improving Plaque Control and Gingival Health

NCT04650685 | Unknown DMC

• 1 other identifier: UKM PPI/111/8/JEP-2020-620
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

Dental plaque is a main etiologic agent in periodontal disease. Global of Burden Disease Study 2016 ranked periodontal disease as the 11th most prevalent disease affecting 10.5% population worldwide. Tooth brushing is a reliable mechanical means to control dental plaque accumulation in order to maintain oral health. For decades, studies have demonstrated the efficiency of unprocessed Salvadora persica (miswak) chewing stick practice as an alternative to a standard toothbrush. Recently, a local Malaysian company has invented and successfully mass manufactured a world-first Salvadora persica toothbrush where its nylon bristles are primarily mixed with miswak powder and natural silica. With the benefits of Salvadora persica properties intact, it is also claimed to be effective without the application of toothpaste. However, the claim remains to be fully elucidated. There is also no randomized controlled trial available evaluating the efficacy of Salvadora persica toothbrush to date. Therefore, the aim of this study is to evaluate the effectiveness of the newly invented Salvadora persica toothbrush on oral health, particularly on anti-plaque and anti-gingivitis effects. The patient related-outcomes of Salvadora persica on a short-term use will also be assessed. The hypotheses of this study are that Salvadora persica toothbrush does not contribute to the significant effects on oral health and there is no difference in the use of Salvadora persica chewing stick, Salvadora persica toothbrush as well as the standard toothbrush on anti-plaque and anti-gingivitis in a standardized manner. Additionally, a hypothesis that there is no patient-related outcome of Salvadora persica on a short-term use has also been devised. A randomized, single blind, and parallel clinical study will be conducted over a five-week period involving the healthy non-dental students of the National University of Malaysia. This study consists of three groups of different oral hygiene tools: (i) Salvadora persica toothbrush; (ii) Salvadora persica chewing stick; and (iii) Standard toothbrush and toothpaste as control. The primary outcomes of this study are the clinical parameters that will be recorded at four different appointments. Salvadora persica toothbrush is expected to show positive effects to that of standard toothbrush with respect to plaque and gingivitis control. This study is thus designed to provide an insight on Salvadora persica toothbrush as a good preventive home care therapy.

Conditions

Gingivitis; Dental Plaque

Keywords

Miswak; Dental biofilms; Periodontal disease

Outcome Measures

Primary Outcomes (3)

• Probing attachment level

  Firstly, the periodontal pocket depth (PPD) will be assessed at six points per tooth. The measurement will be performed using a University of North Carolina probe (PCP-UNC 15) probe, which has a clear black coding of every millimetre demarcation that is up to 15 mm length. Then, probing attachment level will be assessed to the nearest millimetre by the same probe and expressed as the distance in millimetres from the cemento-enamel junction (CEJ) to the base of the pocket. This clinical assessment requires the measurement of the distance from the CEJ to the free gingival margin (FGM) for all six points. Periodontal attachment level is calculated by subtracting the distance of the CEJ to the FGM from the PPD. However, because gingival recession is an exclusion criterion in this study, gingival margin might be located at the CEJ at baseline, hence periodontal attachment level might be of similar value with to PPD.

  5 weeks

• Gingival Index

  This implies the gingival status by the examination of the severity of gingival inflammation. In addition, the initiation of bleeding will be noted by gently stroking the entrance to the gingival sulcus with a blunt periodontal probe. Scores of 0, 1, 2 and 3 will be given. The explanation of the scores are as follows: 0 = Absence of plaque 1. = A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may only be recognized by running a probe across the tooth surface, not visible by the naked eye 2. = Moderate accumulation of soft deposits within the gingival pocket, on the gingival margin and/or adjacent tooth surface, which can be seen by the naked eye 3. = Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface

  5 weeks

• Plaque Index

  Before the presence of dental plaque level is examined, the disclosing solution will be applied on the small cotton swab and then gently dabbed on the tooth surface. The participants will be instructed not to rinse their mouth with water until the examination is completed. Scores of 0, 1, 2 and 3 will be given. The explanation of the scores are as follows: 0 = Absence of plaque 1. = A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may only be recognized by running a probe across the tooth surface, not visible by the naked eye 2. = Moderate accumulation of soft deposits within the gingival pocket, on the gingival margin and/or adjacent tooth surface, which can be by the naked eye 3. = Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface

  5 weeks

Secondary Outcomes (2)

• S-OHIP(M) scores

  3 weeks

• Prevalence of subjective and objective evaluation of adverse events on oral hygiene tool use

  3 weeks

Study Arms (3)

The novel Salvadora persica toothbrush

EXPERIMENTAL

The novel toothbrush is under Al-Abyad Miswak brand that will be supplied by Insight Prestige Sdn Bhd. Participants are expected to use this oral hygiene tool for 3 weeks.

Device: The novel Salvadora persica toothbrush

The Salvadora persica (miswak) chewing sticks

EXPERIMENTAL

The chewing sticks are under the brand of Al-Khair. They will be prepared into equal length of 15 cm with uniform diameter of 1.0-1.5 cm and are sealed in airtight plastic bags. Participants are expected to use this oral hygiene tool for 3 weeks.

Device: The Salvadora persica (miswak) chewing stick

Standard toothbrush and toothpaste (control)

OTHER

Participants will be given straight-handle soft-bristle Oral-B™ standard toothbrush and Colgate® fluoride tooth. Participants are expected to use this oral hygiene tool for 3 weeks.

Device: Standard toothbrush and toothpaste (control)

Interventions

The novel Salvadora persica toothbrush DEVICE

The novel Salvadora persica toothbrush will be used twice daily without the application of toothpaste. Modified bass technique will be applied. A demonstration by another investigator will be done via video, written instructions and a tell-show-do method using typodont model.

The novel Salvadora persica toothbrush

The Salvadora persica (miswak) chewing stick DEVICE

The Salvadora persica chewing stick will be used twice daily without the application of toothpaste. The Salvadora persica chewing sticks need to be prepared prior to use. A five-finger grip technique will be applied. A demonstration by another investigator will be done via video, written instructions and a tell-show-do method using typodont model.

The Salvadora persica (miswak) chewing sticks

Standard toothbrush and toothpaste (control) DEVICE

The novel Salvadora persica toothbrush will be used twice daily without the application of toothpaste. Modified bass technique will be applied. A demonstration by another investigator will be done via video, written instructions and a tell-show-do method using typodont model.

Standard toothbrush and toothpaste (control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals who are systemically healthy
• Individuals who have ≥ 24 teeth
• Individuals who have Basic Periodontal Examination score 0, 1 and 2 only with no periodontal deep pocket more than 5.5mm (gum disease)
• Individuals who have never smoke cigarettes or other tobacco products

You may not qualify if:

• Individuals who are the habitual users of miswak chewing sticks, or have experienced in using them
• Individuals who wear orthodontic appliances (braces)
• Individuals who have grossly decayed teeth, gross overhanging restorations, severe malpositioned teeth (crowded teeth) and/or gingival recession (receding gum), have crowns placed, and wear partial dentures
• Individuals who have current or previous history of periodontal treatment (gum treatment) including root surface debridement/periodontal surgery
• Individuals who are poor in manual dexterity
• Individuals who are pregnant or lactating mothers
• Individuals who have taken antibiotics in the previous 3 months

Sponsors & Collaborators

• National University of Malaysia: lead

Study Sites (1)

Department of Restorative Dentistry, Faculty of Dentistry, National University of Malaysia

Kuala Lumpur, 50300, Malaysia

RECRUITING

Related Publications (9)

• Pihlstrom BL. Measurement of attachment level in clinical trials: probing methods. J Periodontol. 1992 Dec;63(12 Suppl):1072-7. doi: 10.1902/jop.1992.63.12s.1072.

  PMID: 1479528 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

• SILNESS J, LOE H. PERIODONTAL DISEASE IN PREGNANCY. II. CORRELATION BETWEEN ORAL HYGIENE AND PERIODONTAL CONDTION. Acta Odontol Scand. 1964 Feb;22:121-35. doi: 10.3109/00016356408993968. No abstract available.

  PMID: 14158464 BACKGROUND

• Saub R, Locker D, Allison P. Derivation and validation of the short version of the Malaysian Oral Health Impact Profile. Community Dent Oral Epidemiol. 2005 Oct;33(5):378-83. doi: 10.1111/j.1600-0528.2005.00242.x.

  PMID: 16128798 BACKGROUND

• Gibson JA, Wade AB. Plaque removal by the Bass and Roll brushing techniques. J Periodontol. 1977 Aug;48(8):456-9. doi: 10.1902/jop.1977.48.8.456.

  PMID: 269253 BACKGROUND

• Poyato-Ferrera M, Segura-Egea JJ, Bullon-Fernandez P. Comparison of modified Bass technique with normal toothbrushing practices for efficacy in supragingival plaque removal. Int J Dent Hyg. 2003 May;1(2):110-4. doi: 10.1034/j.1601-5037.2003.00018.x.

  PMID: 16451532 BACKGROUND

• 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 BACKGROUND

• Almas K, al-Lafi TR. The natural toothbrush. World Health Forum. 1995;16(2):206-10. No abstract available.

  PMID: 7794468 BACKGROUND

• Azizan NF, Mohd N, Nik Azis NM, Baharin B. Effectiveness of Salvadora persica toothbrush and Salvadora persica chewing stick in plaque and gingivitis control: a randomized control trial. BMC Complement Med Ther. 2023 Dec 14;23(1):456. doi: 10.1186/s12906-023-04295-z.

  PMID: 38098022 DERIVED

Related Links

• The Good Practitioner's Guide to Periodontology

MeSH Terms

Conditions

Gingivitis; Dental Plaque; Periodontal Diseases

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Mouth Diseases; Stomatognathic Diseases; Dental Deposits; Tooth Diseases

Study Officials

• Nurulhuda Mohd, DDS

  Department of Restorative Dentistry, Faculty of Dentistry, National University of Malaysia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nurulhuda Mohd, DDS

CONTACT

0060392897745; nurulhuda.mohd@ukm.edu.my

Nurul Fatin Azizan, BDS

CONTACT

0060392897745; P101498@siswa.ukm.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A research assistant will be responsible for randomisation and grouping hence the outcome assessor will not be aware of which group the participant belonged to. One outcome assessor will be responsible for the clinical evaluations, who will be masked to the intervention groups throughout the study. Individual participants will not be informed about the study hypothesis and will strictly be asked not to disclose to the outcome assessor which oral hygiene tool they are using. This is to ensure the outcome assossor is fully blinded in this study.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator; Lecturer and Clinical Consultant (Periodontist)

Model Details: Group 1: Salvadora persica toothbrush (under the brand of Al-Abyad) that is to be used without toothpaste application. Group 2: Salvadora persica chewing sticks (under the brand of Al-Khair) with uniform diameter (1cm) and equal length of 15 cm. Three miswak chewing sticks will be distributed to each participant (one stick/week). Upon receiving, they will be sealed in air-tight plastic bags. This miswak chewing stick is also to be used without the application of any toothpaste. Group 3: Participants will be given a regular, standard straight-handle soft-bristle Colgate toothbrush each to be used with the application of Colgate® fluoride toothpaste. Professional cleaning of scaling and polishing will be performed if needed during the first visit.

Study Record Dates

• First Submitted: November 25, 2020
• First Posted: December 3, 2020
• Study Start: December 22, 2020
• Primary Completion: August 1, 2021
• Study Completion: October 1, 2021
• Last Updated: January 5, 2021

Record last verified: 2021-01

Locations

MY (1)