Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-26 @ 5:35 PM
Study NCT ID:
NCT04561960
Status:
COMPLETED
Last Update Posted:
2021-03-10
First Post:
2020-09-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Miswak in Oral Hygiene Maintenance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003773', 'term': 'Dental Plaque'}], 'ancestors': [{'id': 'D003741', 'term': 'Dental Deposits'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-08', 'studyFirstSubmitDate': '2020-09-16', 'studyFirstSubmitQcDate': '2020-09-22', 'lastUpdatePostDateStruct': {'date': '2021-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Base line Plaque Score', 'timeFrame': 'Baseline', 'description': 'Silness-Löe Index: #16, #12, #24, #36, #32, #44Missing teeth are not substituted. 0-3, 0 being absent from plaque'}, {'measure': 'Plaque Score change at 1 week', 'timeFrame': 'One week', 'description': 'Silness-Löe Index: #16, #12, #24, #36, #32, #44Missing teeth are not substituted. 0-3, 0 being absent from plaque'}, {'measure': 'Plaque Score change at 2 weeks', 'timeFrame': 'Two weeks', 'description': 'Silness-Löe Index: #16, #12, #24, #36, #32, #44Missing teeth are not substituted. 0-3, 0 being absent from plaque'}, {'measure': 'Baseline Bleeding Score', 'timeFrame': 'Baseline', 'description': 'Gingival Index (Loe \\& Silness 1963): #16, #12, #24, #36, #32, #44Missing teeth are not substituted. 0-4 . 0 being absent from inflammation'}, {'measure': 'Bleeding Score change at 1 week', 'timeFrame': 'One week', 'description': 'Gingival Index (Loe \\& Silness 1963): #16, #12, #24, #36, #32, #44Missing teeth are not substituted. 0-4 . 0 being absent from inflammation'}, {'measure': 'Bleeding Score change at 2 weeks', 'timeFrame': 'Two weeks', 'description': 'Gingival Index (Loe \\& Silness 1963): #16, #12, #24, #36, #32, #44Missing teeth are not substituted. 0-4 . 0 being absent from inflammation'}], 'secondaryOutcomes': [{'measure': 'Presence of White spot lesions', 'timeFrame': 'Two weeks', 'description': 'Visual Initial signs of dental caries'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['miswak', 'siwak', 'S. persica', 'chew stick'], 'conditions': ['Dental Plaque']}, 'referencesModule': {'references': [{'pmid': '3460112', 'type': 'RESULT', 'citation': 'Hawkins BF, Kohout FJ, Lainson PA, Heckert A. Duration of toothbrushing for effective plaque control. Quintessence Int. 1986 Jun;17(6):361-5. No abstract available.'}, {'pmid': '6962424', 'type': 'RESULT', 'citation': 'Elvin-Lewis M. The therapeutic potential of plants used in dental folk medicine. Odontostomatol Trop. 1982 Sep;5(3):107-17. No abstract available.'}, {'pmid': '22628969', 'type': 'RESULT', 'citation': 'Patel PV, Shruthi S, Kumar S. Clinical effect of miswak as an adjunct to tooth brushing on gingivitis. J Indian Soc Periodontol. 2012 Jan;16(1):84-8. doi: 10.4103/0972-124X.94611.'}, {'pmid': '15560804', 'type': 'RESULT', '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': '23960531', 'type': 'RESULT', 'citation': 'Halawany HS. A review on miswak (Salvadora persica) and its effect on various aspects of oral health. Saudi Dent J. 2012 Apr;24(2):63-9. doi: 10.1016/j.sdentj.2011.12.004. Epub 2012 Jan 28.'}, {'pmid': '25935172', 'type': 'RESULT', 'citation': 'Haque MM, Alsareii SA. A review of the therapeutic effects of using miswak (Salvadora Persica) on oral health. Saudi Med J. 2015 May;36(5):530-43. doi: 10.15537/smj.2015.5.10785.'}, {'type': 'RESULT', 'citation': 'Devi, Aruna M.; Hampannavar, Pooja; Radha, G.; Kadanakuppe, Sushi; Nagashree, S. R.; Kumar, Vinod A. (2011) Comparing the Efficacy of Plaque Removal between Salvadora persica (Miswak) and Manual Toothbrush in 12 to 15 Years School Children. World Journal of Dentistry, 2(1), pp. 29-33.'}, {'pmid': '2605858', 'type': 'RESULT', 'citation': 'Norton MR, Addy M. Chewing sticks versus toothbrushes in West Africa. A pilot study. Clin Prev Dent. 1989 May-Jun;11(3):11-3.'}, {'pmid': '25077082', 'type': 'RESULT', 'citation': 'Malik AS, Shaukat MS, Qureshi AA, Abdur R. Comparative effectiveness of chewing stick and toothbrush: a randomized clinical trial. N Am J Med Sci. 2014 Jul;6(7):333-7. doi: 10.4103/1947-2714.136916.'}, {'type': 'RESULT', 'citation': 'World Health Organization. (1997). Oral health surveys: basic methods, 4th ed. World Health Organization'}, {'pmid': '12790510', 'type': 'RESULT', 'citation': 'Darout IA, Skaug N, Albandar JM. Subgingival microbiota levels and their associations with periodontal status at the sampled sites in an adult Sudanese population using miswak or toothbrush regularly. Acta Odontol Scand. 2003 Apr;61(2):115-22. doi: 10.1080/00016350310002784.'}]}, 'descriptionModule': {'briefSummary': 'Miswak has been recommended by world health organization for oral hygiene because of its availability, beneficial effect and affordability. The popularity of Miswak in Arab countries has meant that there have been several studies that have confirmed the ability of miswak to provide effective mechanical and chemical cleansing when used as an adjunct to other oral hygiene aids.\n\nFluoridated tooth paste and manual tooth brushes have been the standard of clinical preventive dental care for over 50 years.However, the objection to the use of fluorides by some parents has meant that these pastes are not universally accepted.\n\nThere are several non-fluoridated pastes available in the market that include the extract of miswak. There are few studies that have compared these pastes to fluoridated pastes and to miswak as a stand alone agents.\n\nMiswak has been recommended by world health organization in 1987 for oral hygiene because of its availability, beneficial effect and affordability.\n\nIt has been stated that "Several clinical studies have confirmed that the mechanical and chemical cleansing efficiency of miswak chewing sticks are equal and at times greater than that of the toothbrush" this was mentioned and reviewed that it is in fact right but only when used in a regular constant matter with a proper and effective way of plaque removal. This study aims to use a cross over model to study the effectiveness of miswak as a stand alone agent in maintaining oral hygiene in young adults and compare it miswak containing toothpastes and fluoridated toothpastes when used with a manual tooth brush.', 'detailedDescription': 'Oral hygiene is the key of maintaining human\'s mouth at a state of equilibrium and free of diseases (e.g. cavities, dental decay, gingivitis, halitosis). Poor oral hygiene can significantly affect the quality of life and has a considerable influence on diet, sleeping, social communication, psychological status, and by being less productive at work.\n\nTherefore, oral hygiene is essential for general health and well-being. Oral hygiene measures include toothbrush which is the most commonly used method for plaque control. However, miswak is a commonly used method in many developing countries.\n\nMiswak has a widespread among religious, rural and developing countries for its spiritual impact since the use of miswak was advised by prophet mohammed (peace be upon him) centuries ago as he said "had I not thought it difficult for my ummah, I would have commanded them to use miswak before every prayer".\n\nMiswak has been recommended by world health organization for oral hygiene because of its availability, beneficial effect and affordability. Previous chemical examinations changed our idea in Miswak which showed us that miswak sticks contain natural ingredients which benefits our oral health. Miswak extracts appear to have different beneficial biological properties like anti-bacterial and anti-fungal effects which will play a high role in oral hygiene measures.\n\nMultiple researches suggested that miswak has anti-cariogenic effects. several studies concluded that Chewing sticks (miswak) has revealed parallel and at times greater mechanical and chemical cleansing of oral tissues as compared to a toothbrush.\n\nThe popularity of Miswak in Arab countries has meant that there have been several studies that have confirmed the ability of miswak to provide effective mechanical and chemical cleansing when used as an adjunct to other oral hygiene aids. In a previous study found that the periodontal health of miswak users was better than the periodontal health of manual toothbrush users, also it was concluded that miswak is more effective than tooth brushing for reducing plaque and gingivitis when preceded by professional instruction regarding its correct application.\n\nAnother research reported the opposite thing, Punit Patel and S. Shruthi studied the clinical effects of miswak as an adjunct to tooth brushing on gingivitis clearly and they find that the indication of miswak cannot replace the toothbrush, but can be used an adjunct to toothbrush, utilizing the mechanical efficacy of toothbrush and chemical effects of miswak.\n\nHowever, it was concluded that "The use of S. persica miswak alone or in combination with conventional toothbrushes, when performed judiciously, will result in superior oral health and hygiene." Fluoridated tooth paste and manual tooth brushes have been the standard of clinical preventive dental care for over 50 years. However, the objection to the use of fluorides by some parents has meant that these pastes are not universally accepted.\n\nThere is a lot of controversy whether the miswak alone can be used for effective plaque removal and good gingival health or should it be only used as an adjunct to tooth brushing.\n\nIn this study we will determine whether the miswak can be used as the chief tool in oral health rather than an adjunct to tooth brushing. We will also determine whether toothpaste using the miswak extract can be as effective as the normal fluoridated toothpaste.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adults\n* Able to perform their own oral hygiene\n* Dental students\n\nExclusion Criteria:\n\n* Active Dental Caries\n* Uncontrolled chronic medical conditions\n* History of drug and/or treatment that reduces salivary flow\n* Currently undergoing orthodontic treatment\n* Missing index teeth #16, #12, #24, #36, #32, #44'}, 'identificationModule': {'nctId': 'NCT04561960', 'briefTitle': 'Efficacy of Miswak in Oral Hygiene Maintenance', 'organization': {'class': 'OTHER', 'fullName': 'Riyadh Elm University'}, 'officialTitle': 'Efficacy of Miswak When Compared to Fluoridated Toothpaste for the Maintenance of Oral Hygiene in Young Adults', 'orgStudyIdInfo': {'id': 'FRP/2020/264'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Participants will be trained to perform oral hygiene using the modified bass technique.\n\nThe participants will be asked to brush their teeth twice daily using a manual tooth brush and fluoridated toothpaste containing 1450ppm of fluoride', 'interventionNames': ['Drug: Fluoride toothpaste', 'Device: Toothbrush']}, {'type': 'EXPERIMENTAL', 'label': 'Miswak', 'description': 'Participants will be trained to chew and condition a miswak stick Participants will be asked to use the miswak stick twice daily', 'interventionNames': ['Device: Miswak Stick']}, {'type': 'EXPERIMENTAL', 'label': 'Miswak Paste', 'description': 'Participants will be trained to perform oral hygiene using the modified bass technique.\n\nThe participants will be asked to brush their teeth twice daily using a manual tooth brush a non-fluoridated toothpaste containing miswak extract', 'interventionNames': ['Drug: Toothpaste Product', 'Device: Toothbrush']}], 'interventions': [{'name': 'Fluoride toothpaste', 'type': 'DRUG', 'description': 'Fluoridated paste containing 1450ppm NaF', 'armGroupLabels': ['Control']}, {'name': 'Toothpaste Product', 'type': 'DRUG', 'description': 'Non Fluoridated toothpaste with extract of miswak ( Dabur, miswak tooth paste)', 'armGroupLabels': ['Miswak Paste']}, {'name': 'Toothbrush', 'type': 'DEVICE', 'description': 'Colgate classic clean Soft bristled toothbrushes, 19.05 x 1.27 x 1.91 cm', 'armGroupLabels': ['Control', 'Miswak Paste']}, {'name': 'Miswak Stick', 'type': 'DEVICE', 'description': 'A miswak stick of 15 cm length', 'armGroupLabels': ['Miswak']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Riyadh', 'country': 'Saudi Arabia', 'facility': 'Riyadh Elm University', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}], 'overallOfficials': [{'name': 'Omar Alkadhi, MSc', 'role': 'STUDY_CHAIR', 'affiliation': 'Head of IRB, REU'}, {'name': 'Sarah S Aburaisi, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistant Professor, prothetic dental department, REU'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riyadh Elm University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sarah Samer Aburaisi', 'investigatorAffiliation': 'Riyadh Elm University'}}}}