Dentine HypersensitivityNCT04179994
Efficacy of Miswak Extract Toothpaste as Compared Potassium Nitrate in The Management of Dentinal Hypersensitivity
A study testing Miswak extract-containing toothpaste and Potassium nitrates-containing toothpaste in people with Dentine Hypersensitivity, run by Ministry of Health, Saudi Arabia.
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. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Dentine Hypersensitivity
- What is being tested?
- Miswak extract-containing toothpaste and Potassium nitrates-containing toothpaste
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2020to 25 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of Clinical Efficacy of a Miswak Extract-Containing Toothpaste to a Dentifrice Containing Potassium Nitrate and to a Placebo on Dentinal Hypersensitivity: A Randomized Clinical Trial
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.
Read the detailed 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.
- Conditions
- Dentine Hypersensitivity
- Being tested
- Miswak extract-containing toothpaste, Potassium nitrates-containing toothpaste, Placebo
- Medical subject headings
- Dentin Sensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Miswak extract-containing toothpasteOther
Also called Test group
Miswak extract-containing toothpaste will be applied to the tooth diagnosed with DH
Potassium nitrates-containing toothpasteOther
Also called Positive control
Potassium nitrates-containing toothpaste will be applied to the tooth diagnosed with DH
PlaceboOther
Also called Negative control as placebo
A toothpaste containing the same ingredients of the test toothpaste except for the active ingredient
| Study group | Role | What they receive |
|---|---|---|
| Miswak extract-containing toothpaste group | Experimental | Test group. Receives: Other: Miswak extract-containing toothpaste |
| Toothpaste containing Potassium Nitrates | Active comparator | Positive control. Receives: Other: Potassium nitrates-containing toothpaste |
| Placebo group | Placebo comparator | Toothpaste contains same ingredients of test group except for the active ingredient as negative control. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study start1 Jan 2020 (estimated)
- Primary completion25 Apr 2020 (estimated)
- Study completion25 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Dentine HypersensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will be a single-center, longitudinal, triple-masked (for participants, operators, and statistician), equal ratio, randomized non-crossover design.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Saudi Arabia
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Abdulrahman Alshehri, Ministry of Health, Saudi Arabia
- Investigators
- Abdulrahman Alshehri, MS, Principal investigator, Ministry of Health, Saudi Arabia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04179994
- Sponsor's protocol ID
- MoHSaudiArabia
- Status last verified
- Nov 2019
- First submitted
- 25 Nov 2019
- Last updated
- 29 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We can share these data for the seek of spreading knowledge in any case if there is no conflicts for any body.
Publications
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.
PubMed 15560804BRAENNSTROEM 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.
PubMed 14183350Canadian 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.
PubMed 12662460Cunha-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.
PubMed 23449905Douglas-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.
PubMed 29262305Dowell 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.
PubMed 6309917Favaro 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.
PubMed 30639724Gillam 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.
PubMed 10520145Hattab FN. Meswak: the natural toothbrush. J Clin Dent. 1997;8(5):125-9.
PubMed 9487831Holland 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.
PubMed 9402502Markowitz K, Kim S. The role of selected cations in the desensitization of intradental nerves. Proc Finn Dent Soc. 1992;88 Suppl 1:39-54.
PubMed 1508896Rees 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.
PubMed 16451464Schiff 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.
PubMed 8534380Moher 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.
PubMed 22036893Sofrata 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.
PubMed 21829688
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Clinical Efficacy of a Miswak Extract-Containing Toothpaste to a Dentifrice Containing Potassium Nitrate and to a Placebo on Dentinal Hypersensitivity: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04179994
- Acronym / sponsor ID
- MoHSaudiArabia
- Conditions
- Dentine Hypersensitivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Ministry of Health, Saudi ArabiaOther government
- Study start
- 1 Jan 2020 (estimated)
- Primary completion
- 25 Apr 2020 (estimated)
- Study completion
- 25 Jul 2020 (estimated)
- First posted
- 27 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- The study will be a single-center, longitudinal, triple-masked (for participants, operators, and statistician), equal ratio, randomized non-crossover design.
| Arm | Type | Receives |
|---|---|---|
| Miswak extract-containing toothpaste group | Experimental | Other: Miswak extract-containing toothpasteTest group. |
| Toothpaste containing Potassium Nitrates | Active comparator | Other: Potassium nitrates-containing toothpastePositive control. |
| Placebo group | Placebo comparator | Other: PlaceboToothpaste contains same ingredients of test group except for the active ingredient as negative control. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Miswak extract-containing toothpasteAlso: Test groupMiswak extract-containing toothpaste will be applied to the tooth diagnosed with DH | Other | Miswak extract-containing toothpaste group |
| Potassium nitrates-containing toothpasteAlso: Positive controlPotassium nitrates-containing toothpaste will be applied to the tooth diagnosed with DH | Other | Toothpaste containing Potassium Nitrates |
| PlaceboAlso: Negative control as placeboA toothpaste containing the same ingredients of the test toothpaste except for the active ingredient | Other | Placebo group |
Primary outcome
Pain reduction
Time frame: 6 weeks period
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2019.
- Background: PubMed 15560804Al-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.
- Background: PubMed 14183350BRAENNSTROEM 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.
- Background: PubMed 12662460Canadian 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.
- Background: PubMed 23449905Cunha-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.
- Background: PubMed 29262305Douglas-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.
- Background: PubMed 6309917Dowell 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.
- Background: PubMed 30639724Favaro 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.
- Background: PubMed 10520145Gillam 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.
- Background: PubMed 9487831Hattab FN. Meswak: the natural toothbrush. J Clin Dent. 1997;8(5):125-9.
- Background: PubMed 9402502Holland 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.
- Background: PubMed 1508896Markowitz K, Kim S. The role of selected cations in the desensitization of intradental nerves. Proc Finn Dent Soc. 1992;88 Suppl 1:39-54.
- Background: PubMed 16451464Rees 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.
- Individual participant dataSharing planned: Yes. We can share these data for the seek of spreading knowledge in any case if there is no conflicts for any body.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdulrahman Alshehri, MS principal investigator
Ministry of Health, Saudi Arabia
Questions about this trial
What is this clinical trial studying?
A study testing Miswak extract-containing toothpaste and Potassium nitrates-containing toothpaste in people with Dentine Hypersensitivity, run by Ministry of Health, Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abdulrahman Alshehri, MS (00966507090251, Alshehriabdulrahman3@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain reduction (time frame: 6 weeks period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04179994, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2019; AzTrials last refreshed its copy on 6 Nov 2026.