Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2026-02-27 @ 4:32 PM
Study NCT ID:
NCT04179994
Status:
UNKNOWN
Last Update Posted:
2019-11-29
First Post:
2019-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Miswak Extract Toothpaste as Compared Potassium Nitrate in The Management of Dentinal Hypersensitivity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003807', 'term': 'Dentin Sensitivity'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study will be a single-center, longitudinal, triple-masked (for participants, operators, and statistician), equal ratio, randomized non-crossover design.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2020-07-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-26', 'studyFirstSubmitDate': '2019-11-25', 'studyFirstSubmitQcDate': '2019-11-25', 'lastUpdatePostDateStruct': {'date': '2019-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain reduction', 'timeFrame': '6 weeks period', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dentine Hypersensitivity']}, 'referencesModule': {'references': [{'pmid': '15560804', 'type': 'BACKGROUND', 'citation': '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': '14183350', 'type': 'BACKGROUND', '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. doi: 10.1177/00220345640430041601. No abstract available.'}, {'pmid': '12662460', 'type': 'BACKGROUND', '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.'}, {'pmid': '23449905', 'type': 'BACKGROUND', '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. doi: 10.14219/jada.archive.2013.0116.'}, {'pmid': '29262305', 'type': 'BACKGROUND', '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.'}, {'pmid': '6309917', 'type': 'BACKGROUND', '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. doi: 10.1111/j.1600-051x.1983.tb01283.x.'}, {'pmid': '30639724', 'type': 'BACKGROUND', '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.'}, {'pmid': '10520145', 'type': 'BACKGROUND', '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. doi: 10.1046/j.1365-2842.1999.00436.x.'}, {'pmid': '9487831', 'type': 'BACKGROUND', 'citation': 'Hattab FN. Meswak: the natural toothbrush. J Clin Dent. 1997;8(5):125-9.'}, {'pmid': '9402502', 'type': 'BACKGROUND', '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. doi: 10.1111/j.1600-051x.1997.tb01194.x.'}, {'pmid': '1508896', 'type': 'BACKGROUND', '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.'}, {'pmid': '16451464', 'type': 'BACKGROUND', '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. doi: 10.1111/j.1601-5029.2004.00068.x.'}, {'pmid': '8534380', 'type': 'BACKGROUND', '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.'}, {'pmid': '22036893', 'type': 'BACKGROUND', 'citation': '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': '21829688', 'type': 'BACKGROUND', 'citation': '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': '1586280', 'type': 'BACKGROUND', 'citation': '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': '18715354', 'type': 'BACKGROUND', '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. No abstract available.'}, {'pmid': '2355124', 'type': 'BACKGROUND', '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. doi: 10.1177/00220345900690061401.'}, {'pmid': '26694786', 'type': 'RESULT', '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.12195. Epub 2015 Dec 22.'}, {'pmid': '8295089', 'type': 'RESULT', '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. doi: 10.1902/jop.1993.64.11.1045."}, {'pmid': '28652142', 'type': 'RESULT', '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.'}, {'pmid': '23248560', 'type': 'RESULT', '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.'}, {'pmid': '29789771', 'type': 'RESULT', '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.'}, {'pmid': '20370417', 'type': 'RESULT', '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 Aug;81(8):1167-73. doi: 10.1902/jop.2010.100056.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nAfter 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.\n\nDuring 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with history of DH caused by cervical erosion or gingival recession\n* Subjects show good general health\n* Must have at least two teeth with VAS score of 4 or more\n\nExclusion Criteria:\n\n* Subjects have teeth with caries, occlusal restorations, or orthodontic appliances\n* Subjects allergic to ingredients used in the study\n* Subjects present any oral pathology, eating disorders, chronic disease, or any disease requiring repeated or regular analgesia, anti-inflammatory drugs, or antihistamines'}, 'identificationModule': {'nctId': 'NCT04179994', 'briefTitle': 'Efficacy of Miswak Extract Toothpaste as Compared Potassium Nitrate in The Management of Dentinal Hypersensitivity', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Ministry of Health, Saudi Arabia'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'MoHSaudiArabia'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Miswak extract-containing toothpaste group', 'description': 'Test group.', 'interventionNames': ['Other: Miswak extract-containing toothpaste']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Toothpaste containing Potassium Nitrates', 'description': 'Positive control.', 'interventionNames': ['Other: Potassium nitrates-containing toothpaste']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'Toothpaste contains same ingredients of test group except for the active ingredient as negative control.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Miswak extract-containing toothpaste', 'type': 'OTHER', 'otherNames': ['Test group'], 'description': 'Miswak extract-containing toothpaste will be applied to the tooth diagnosed with DH', 'armGroupLabels': ['Miswak extract-containing toothpaste group']}, {'name': 'Potassium nitrates-containing toothpaste', 'type': 'OTHER', 'otherNames': ['Positive control'], 'description': 'Potassium nitrates-containing toothpaste will be applied to the tooth diagnosed with DH', 'armGroupLabels': ['Toothpaste containing Potassium Nitrates']}, {'name': 'Placebo', 'type': 'OTHER', 'otherNames': ['Negative control as placebo'], 'description': 'A toothpaste containing the same ingredients of the test toothpaste except for the active ingredient', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Abdulrahman Alshehri, MS', 'role': 'CONTACT', 'email': 'Alshehriabdulrahman3@gmail.com', 'phone': '00966507090251'}], 'overallOfficials': [{'name': 'Abdulrahman Alshehri, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ministry of Health, Saudi Arabia'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'From June 2020 to January 2021.', 'ipdSharing': 'YES', 'description': 'We can share these data for the seek of spreading knowledge in any case if there is no conflicts for any body.', 'accessCriteria': 'Data can be send to a researchers who will get scientific benefit of them. By mean of paper or electronic mails.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ministry of Health, Saudi Arabia', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Abdulrahman Alshehri', 'investigatorAffiliation': 'Ministry of Health, Saudi Arabia'}}}}