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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04179994
Other study ID # MoHSaudiArabia
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 1, 2020
Est. completion date July 25, 2020

Study information

Verified date November 2019
Source Ministry of Health, Saudi Arabia
Contact Abdulrahman Alshehri, MS
Phone 00966507090251
Email Alshehriabdulrahman3@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Three toothpastes will be investigated during the study period that are 1) commercially available miswak extract-containing toothpaste; 2) commercially available toothpaste containing 5% potassium nitrate as positive control; 3) a toothpaste containing the same formulation as miswak extract except for the active ingredient (miswak extract) as negative control. Toothpastes will be dispensed in labeled containers named A,B, and C to achieve the triple masking for investigators, participants, and statisticians. Masked toothpastes will be revealed to the investigators after the statistical analyses.

After allocation, all subjects will be instructed to refrain from using any desensitizing agents for two weeks prior to the study up to the end of study period. The randomization process will be made using SPSS, the function "RAND" to assign every subject to random A, B, or C masked toothpastes. Moreover, to insure the blinded process of the study we will dispense the toothpastes in a previously prepared similar containers in separate area. Two trained examiners will read and record the scores each visit (baseline, 2-weeks, and 6-weeks). For the seek of examiners' calibration, Kappa statistic will be used to assess the inter-rater reproducibility and we will duplicate a 10% of the study results.

During each visit, teeth around the targeted tooth will be isolated with cotton rolls then the stimuli will be applied using a sharp dental explorer. It will be passed across the facial area of the tooth, perpendicular to the tooth long axis. The average of three consecutive applications will be recorded as a the reading for that tooth.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 96
Est. completion date July 25, 2020
Est. primary completion date April 25, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 55 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design


Intervention

Other:
Miswak extract-containing toothpaste
Miswak extract-containing toothpaste will be applied to the tooth diagnosed with DH
Potassium nitrates-containing toothpaste
Potassium nitrates-containing toothpaste will be applied to the tooth diagnosed with DH
Placebo
A toothpaste containing the same ingredients of the test toothpaste except for the active ingredient

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ministry of Health, Saudi Arabia

References & Publications (24)

Al-Otaibi M, Al-Harthy M, Gustafsson A, Johansson A, Claesson R, Angmar-Månsson B. Subgingival plaque microbiota in Saudi Arabians after use of miswak chewing stick and toothbrush. J Clin Periodontol. 2004 Dec;31(12):1048-53. — View Citation

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.121 — View Citation

BRAENNSTROEM M, ASTROEM A. A STUDY ON THE MECHANISM OF PAIN ELICITED FROM THE DENTIN. J Dent Res. 1964 Jul-Aug;43:619-25. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Dowell P, Addy M. Dentine hypersensitivity--a review. Aetiology, symptoms and theories of pain production. J Clin Periodontol. 1983 Jul;10(4):341-50. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. Review. — View Citation

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. — View Citation

Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche 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. Review. — View Citation

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 Au — View Citation

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. Review. — View Citation

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. — View Citation

Sofrata A, Santangelo EM, Azeem M, Borg-Karlson AK, Gustafsson A, Pütsep 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. — View Citation

Vongsavan N, Matthews B. Fluid flow through cat dentine in vivo. Arch Oral Biol. 1992 Mar;37(3):175-85. — View Citation

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. Review. — View Citation

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. — View Citation

* Note: There are 24 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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