Efficacy of Miswak Extract Toothpaste as Compared Potassium Nitrate in The Management of Dentinal Hypersensitivity

NCT04179994 | Unknown DMC

• 1 other identifier: MoHSaudiArabia
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study will be a single-center, longitudinal, triple-masked (for participants, operators, and statistician), equal ratio, randomized non-crossover design. The study designed following the criteria described by Holland et al 1997. The current experiments will follow CONSORT guidelines and will be registered at the US National Institutes of Health (ClinicalTrials.gov). The sensitivity scores will be measured at three intervals: at baseline, at 2 weeks, and at 6 weeks. The duration of the current study estimated to be 6 weeks and will be conducted between January 2020 and March 2020. The study protocol will be submitted initially to the Ethical Committee of the Aseer Central Hospital, Aseer region, Saudi Arabia. After getting the approval and facilitation letters, the participants will be selected randomly from patients attending periodontal clinics at Aseer Dental Center, Aseer region.

Conditions

Dentine Hypersensitivity

Outcome Measures

Primary Outcomes (1)

• Pain reduction

  Visual Analog Scale (VAS) will be used to measure pain intensity. The scale is graded from 1 to 10 with zero score indicates a pain-free response and 10 indicates sever pain or discomfort.

  6 weeks period

Study Arms (3)

Miswak extract-containing toothpaste group

EXPERIMENTAL

Test group.

Other: Miswak extract-containing toothpaste

Toothpaste containing Potassium Nitrates

ACTIVE COMPARATOR

Positive control.

Other: Potassium nitrates-containing toothpaste

Placebo group

PLACEBO COMPARATOR

Toothpaste contains same ingredients of test group except for the active ingredient as negative control.

Other: Placebo

Interventions

Miswak extract-containing toothpaste OTHER

Miswak extract-containing toothpaste will be applied to the tooth diagnosed with DH

Also known as: Test group

Miswak extract-containing toothpaste group

Potassium nitrates-containing toothpaste OTHER

Potassium nitrates-containing toothpaste will be applied to the tooth diagnosed with DH

Also known as: Positive control

Toothpaste containing Potassium Nitrates

Placebo OTHER

A toothpaste containing the same ingredients of the test toothpaste except for the active ingredient

Also known as: Negative control as placebo

Placebo group

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects with history of DH caused by cervical erosion or gingival recession
• Subjects show good general health
• Must have at least two teeth with VAS score of 4 or more

You may not qualify if:

• Subjects have teeth with caries, occlusal restorations, or orthodontic appliances
• Subjects allergic to ingredients used in the study
• Subjects present any oral pathology, eating disorders, chronic disease, or any disease requiring repeated or regular analgesia, anti-inflammatory drugs, or antihistamines

Sponsors & Collaborators

• Ministry of Health, Saudi Arabia: lead

Related Publications (24)

• 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

• BRAENNSTROEM M, ASTROEM A. A STUDY ON THE MECHANISM OF PAIN ELICITED FROM THE DENTIN. J Dent Res. 1964 Jul-Aug;43:619-25. doi: 10.1177/00220345640430041601. No abstract available.

  PMID: 14183350 BACKGROUND

• Canadian Advisory Board on Dentin Hypersensitivity. Consensus-based recommendations for the diagnosis and management of dentin hypersensitivity. J Can Dent Assoc. 2003 Apr;69(4):221-6.

  PMID: 12662460 BACKGROUND

• Cunha-Cruz J, Wataha JC, Heaton LJ, Rothen M, Sobieraj M, Scott J, Berg J; Northwest Practice-based Research Collaborative in Evidence-based DENTistry. The prevalence of dentin hypersensitivity in general dental practices in the northwest United States. J Am Dent Assoc. 2013 Mar;144(3):288-96. doi: 10.14219/jada.archive.2013.0116.

  PMID: 23449905 BACKGROUND

• Douglas-de-Oliveira DW, Vitor GP, Silveira JO, Martins CC, Costa FO, Cota LOM. Effect of dentin hypersensitivity treatment on oral health related quality of life - A systematic review and meta-analysis. J Dent. 2018 Apr;71:1-8. doi: 10.1016/j.jdent.2017.12.007. Epub 2017 Dec 17.

  PMID: 29262305 BACKGROUND

• Dowell P, Addy M. Dentine hypersensitivity--a review. Aetiology, symptoms and theories of pain production. J Clin Periodontol. 1983 Jul;10(4):341-50. doi: 10.1111/j.1600-051x.1983.tb01283.x.

  PMID: 6309917 BACKGROUND

• Favaro Zeola L, Soares PV, Cunha-Cruz J. Prevalence of dentin hypersensitivity: Systematic review and meta-analysis. J Dent. 2019 Feb;81:1-6. doi: 10.1016/j.jdent.2018.12.015. Epub 2019 Jan 11.

  PMID: 30639724 BACKGROUND

• Gillam DG, Seo HS, Bulman JS, Newman HN. Perceptions of dentine hypersensitivity in a general practice population. J Oral Rehabil. 1999 Sep;26(9):710-4. doi: 10.1046/j.1365-2842.1999.00436.x.

  PMID: 10520145 BACKGROUND

• Hattab FN. Meswak: the natural toothbrush. J Clin Dent. 1997;8(5):125-9.

  PMID: 9487831 BACKGROUND

• Holland GR, Narhi MN, Addy M, Gangarosa L, Orchardson R. Guidelines for the design and conduct of clinical trials on dentine hypersensitivity. J Clin Periodontol. 1997 Nov;24(11):808-13. doi: 10.1111/j.1600-051x.1997.tb01194.x.

  PMID: 9402502 BACKGROUND

• Markowitz K, Kim S. The role of selected cations in the desensitization of intradental nerves. Proc Finn Dent Soc. 1992;88 Suppl 1:39-54.

  PMID: 1508896 BACKGROUND

• Rees JS, Addy M. A cross-sectional study of buccal cervical sensitivity in UK general dental practice and a summary review of prevalence studies. Int J Dent Hyg. 2004 May;2(2):64-9. doi: 10.1111/j.1601-5029.2004.00068.x.

  PMID: 16451464 BACKGROUND

• Schiff T, Dotson M, Cohen S, De Vizio W, McCool J, Volpe A. Efficacy of a dentifrice containing potassium nitrate, soluble pyrophosphate, PVM/MA copolymer, and sodium fluoride on dentinal hypersensitivity: a twelve-week clinical study. J Clin Dent. 1994;5 Spec No:87-92.

  PMID: 8534380 BACKGROUND

• Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG; CONSORT. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. Int J Surg. 2012;10(1):28-55. doi: 10.1016/j.ijsu.2011.10.001. Epub 2011 Oct 12.

  PMID: 22036893 BACKGROUND

• Sofrata A, Santangelo EM, Azeem M, Borg-Karlson AK, Gustafsson A, Putsep K. Benzyl isothiocyanate, a major component from the roots of Salvadora persica is highly active against Gram-negative bacteria. PLoS One. 2011;6(8):e23045. doi: 10.1371/journal.pone.0023045. Epub 2011 Aug 1.

  PMID: 21829688 BACKGROUND

• Vongsavan N, Matthews B. Fluid flow through cat dentine in vivo. Arch Oral Biol. 1992 Mar;37(3):175-85. doi: 10.1016/0003-9969(92)90087-o.

  PMID: 1586280 BACKGROUND

• West NX. Dentine hypersensitivity: preventive and therapeutic approaches to treatment. Periodontol 2000. 2008;48:31-41. doi: 10.1111/j.1600-0757.2008.00262.x. No abstract available.

  PMID: 18715354 BACKGROUND

• Yoshiyama M, Noiri Y, Ozaki K, Uchida A, Ishikawa Y, Ishida H. Transmission electron microscopic characterization of hypersensitive human radicular dentin. J Dent Res. 1990 Jun;69(6):1293-7. doi: 10.1177/00220345900690061401.

  PMID: 2355124 BACKGROUND

• Azaripour A, Mahmoodi B, Habibi E, Willershausen I, Schmidtmann I, Willershausen B. Effectiveness of a miswak extract-containing toothpaste on gingival inflammation: a randomized clinical trial. Int J Dent Hyg. 2017 Aug;15(3):195-202. doi: 10.1111/idh.12195. Epub 2015 Dec 22.

  PMID: 26694786 RESULT

• Dragolich WE, Pashley DH, Brennan WA, O'Neal RB, Horner JA, Van Dyke TE. An in vitro study of dentinal tubule occlusion by ferric oxalate. J Periodontol. 1993 Nov;64(11):1045-51. doi: 10.1902/jop.1993.64.11.1045.

  PMID: 8295089 RESULT

• Gallob J, Sufi F, Amini P, Siddiqi M, Mason S. A randomised exploratory clinical evaluation of dentifrices used as controls in dentinal hypersensitivity studies. J Dent. 2017 Sep;64:80-87. doi: 10.1016/j.jdent.2017.06.009. Epub 2017 Jun 23.

  PMID: 28652142 RESULT

• Gupta P, Agarwal N, Anup N, Manujunath BC, Bhalla A. Evaluating the anti-plaque efficacy of meswak (Salvadora persica) containing dentifrice: A triple blind controlled trial. J Pharm Bioallied Sci. 2012 Oct;4(4):282-5. doi: 10.4103/0975-7406.103238.

  PMID: 23248560 RESULT

• Mason S, Kingston R, Shneyer L, Harding M. Clinical study to monitor dentinal hypersensitivity with episodic use of a desensitising dentifrice. BDJ Open. 2017 Jun 23;3:17011. doi: 10.1038/bdjopen.2017.11. eCollection 2017.

  PMID: 29789771 RESULT

• Pradeep AR, Sharma A. Comparison of clinical efficacy of a dentifrice containing calcium sodium phosphosilicate to a dentifrice containing potassium nitrate and to a placebo on dentinal hypersensitivity: a randomized clinical trial. J Periodontol. 2010 Aug;81(8):1167-73. doi: 10.1902/jop.2010.100056.

  PMID: 20370417 RESULT

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Abdulrahman Alshehri, MS

  Ministry of Health, Saudi Arabia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abdulrahman Alshehri, MS

CONTACT

00966507090251; Alshehriabdulrahman3@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The study will be a single-center, longitudinal, triple-masked (for participants, operators, and statistician), equal ratio, randomized non-crossover design.

Study Record Dates

• First Submitted: November 25, 2019
• First Posted: November 27, 2019
• Study Start: January 1, 2020
• Primary Completion: April 25, 2020
• Study Completion: July 25, 2020
• Last Updated: November 29, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: From June 2020 to January 2021.
• Access Criteria: Data can be send to a researchers who will get scientific benefit of them. By mean of paper or electronic mails.