Ignite Creation Date:
2025-12-24 @ 10:39 PM
Ignite Modification Date:
2026-01-01 @ 10:39 AM
Study NCT ID:
NCT06575335
Status:
COMPLETED
Last Update Posted:
2025-02-17
First Post:
2024-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Triphala Tooth Wipes in Reduction of Streptococcus Mutans Colonies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'It will be a double-blinded study where the participants and the microbiologist will be unaware of the group allocation.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The participants will be allocated in either of the two treatment arms through Sequentially Numbered, Opaque, Sealed Envelopes (SNOSE) by the principal investigator.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-11-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-13', 'studyFirstSubmitDate': '2024-08-22', 'studyFirstSubmitQcDate': '2024-08-26', 'lastUpdatePostDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Streptococcus mutans (S. mutans) count', 'timeFrame': 'The S. mutans count will be assessed at baseline and at day 8 of the intervention.', 'description': 'Colony Forming Unit per millilitre (CFU/ml) classified as Class 0 (none), Class 1 (\\<102), Class 2 (103-104) and Class 3 (10≥5) CFU/ml showing negligible, low, moderate and high caries susceptibility'}], 'secondaryOutcomes': [{'measure': 'Plaque Index', 'timeFrame': 'These counts will be assessed at baseline and at day 8 of the intervention.', 'description': 'Silness and Loe Plaque Index: The score will range from 0 to 3; 0 (excellent), 0.1-0.9 (good), 1.0-1.9 (fair), and 2.0-3.0 (poor) oral hygiene.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['differently abled', 'triphala', 'chlorhexidine', 'tooth wipes'], 'conditions': ['Plaque Control']}, 'referencesModule': {'references': [{'pmid': '31372904', 'type': 'BACKGROUND', 'citation': 'Mosaddad SA, Tahmasebi E, Yazdanian A, Rezvani MB, Seifalian A, Yazdanian M, Tebyanian H. Oral microbial biofilms: an update. Eur J Clin Microbiol Infect Dis. 2019 Nov;38(11):2005-2019. doi: 10.1007/s10096-019-03641-9. Epub 2019 Aug 1.'}, {'pmid': '33938347', 'type': 'BACKGROUND', 'citation': 'Lin Y, Chen J, Zhou X, Li Y. Inhibition of Streptococcus mutans biofilm formation by strategies targeting the metabolism of exopolysaccharides. Crit Rev Microbiol. 2021 Sep;47(5):667-677. doi: 10.1080/1040841X.2021.1915959. Epub 2021 May 3.'}, {'pmid': '22143733', 'type': 'BACKGROUND', 'citation': 'Baca P, Castillo AM, Liebana MJ, Castillo F, Martin-Platero A, Liebana J. Horizontal transmission of Streptococcus mutans in schoolchildren. Med Oral Patol Oral Cir Bucal. 2012 May 1;17(3):e495-500. doi: 10.4317/medoral.17592.'}, {'pmid': '30657107', 'type': 'BACKGROUND', 'citation': 'Lemos JA, Palmer SR, Zeng L, Wen ZT, Kajfasz JK, Freires IA, Abranches J, Brady LJ. The Biology of Streptococcus mutans. Microbiol Spectr. 2019 Jan;7(1):10.1128/microbiolspec.gpp3-0051-2018. doi: 10.1128/microbiolspec.GPP3-0051-2018.'}, {'pmid': '34727414', 'type': 'BACKGROUND', 'citation': 'Lin Y, Zhou X, Li Y. Strategies for Streptococcus mutans biofilm dispersal through extracellular polymeric substances disruption. Mol Oral Microbiol. 2022 Feb;37(1):1-8. doi: 10.1111/omi.12355. Epub 2021 Nov 22.'}, {'pmid': '32774378', 'type': 'BACKGROUND', 'citation': 'da Rosa SV, Moyses SJ, Theis LC, Soares RC, Moyses ST, Werneck RI, Rocha JS. Barriers in Access to Dental Services Hindering the Treatment of People with Disabilities: A Systematic Review. Int J Dent. 2020 Jul 23;2020:9074618. doi: 10.1155/2020/9074618. eCollection 2020.'}, {'pmid': '32826897', 'type': 'BACKGROUND', 'citation': 'Carniello V, Peterson BW, van der Mei HC, Busscher HJ. Role of adhesion forces in mechanosensitive channel gating in Staphylococcus aureus adhering to surfaces. NPJ Biofilms Microbiomes. 2020 Aug 21;6(1):31. doi: 10.1038/s41522-020-00141-z.'}, {'pmid': '33852738', 'type': 'BACKGROUND', 'citation': 'Deshpande MA, Baliga S, Thosar N, Rathi N, Jyothishi S, Deulkar PV, Bane SP. Evaluation of antibacterial efficacy of Triphala toothwipes on oral Streptococcus mutans count in intellectually disabled children. Spec Care Dentist. 2021 Sep;41(5):619-625. doi: 10.1111/scd.12597. Epub 2021 Apr 14.'}, {'pmid': '24872616', 'type': 'BACKGROUND', 'citation': 'Prakash S, Shelke AU. Role of Triphala in dentistry. J Indian Soc Periodontol. 2014 Mar;18(2):132-5. doi: 10.4103/0972-124X.131299.'}, {'pmid': '32308299', 'type': 'BACKGROUND', 'citation': 'Penmetsa GS, B V, Bhupathi AP, Rani P S, B V S, M V R. Comparative Evaluation of Triphala, Aloe vera, and Chlorhexidine Mouthwash on Gingivitis: A Randomized Controlled Clinical Trial. Contemp Clin Dent. 2019 Apr-Jun;10(2):333-337. doi: 10.4103/ccd.ccd_583_18.'}, {'pmid': '15652269', 'type': 'BACKGROUND', 'citation': 'Kaur S, Michael H, Arora S, Harkonen PL, Kumar S. The in vitro cytotoxic and apoptotic activity of Triphala--an Indian herbal drug. J Ethnopharmacol. 2005 Feb 10;97(1):15-20. doi: 10.1016/j.jep.2004.09.050. Epub 2004 Dec 25.'}, {'pmid': '18928142', 'type': 'BACKGROUND', 'citation': 'Biradar YS, Singh R, Sharma K, Dhalwal K, Bodhankar SL, Khandelwal KR. Evaluation of anti-diarrhoeal property and acute toxicity of Triphala Mashi, an Ayurvedic formulation. J Herb Pharmacother. 2007;7(3-4):203-12. doi: 10.1080/15228940802152869.'}, {'pmid': '31680053', 'type': 'BACKGROUND', 'citation': 'Phetkate P, Kummalue T, Rinthong PO, Kietinun S, Sriyakul K. Study of the safety of oral Triphala aqueous extract on healthy volunteers. J Integr Med. 2020 Jan;18(1):35-40. doi: 10.1016/j.joim.2019.10.002. Epub 2019 Oct 16.'}, {'pmid': '28696777', 'type': 'BACKGROUND', 'citation': 'Peterson CT, Denniston K, Chopra D. Therapeutic Uses of Triphala in Ayurvedic Medicine. J Altern Complement Med. 2017 Aug;23(8):607-614. doi: 10.1089/acm.2017.0083. Epub 2017 Jul 11.'}, {'pmid': '30397374', 'type': 'BACKGROUND', 'citation': 'Padiyar B, Marwah N, Gupta S, Padiyar N. Comparative Evaluation of Effects of Triphala, Garlic Extracts, and Chlorhexidine Mouthwashes on Salivary Streptococcus mutans Counts and Oral Hygiene Status. Int J Clin Pediatr Dent. 2018 Jul-Aug;11(4):299-306. doi: 10.5005/jp-journals-10005-1530. Epub 2018 Aug 1.'}, {'pmid': '36110780', 'type': 'BACKGROUND', 'citation': 'Selvi MM, Selvabalaji A, Chonat A, Ananthan V, Mani E, Chinnaswamy AD. A Comparative Evaluation of Antimicrobial Efficacy of Triphala and Calcium Hydroxide as Intracanal Medicament: An In Vitro Study. J Pharm Bioallied Sci. 2022 Jul;14(Suppl 1):S774-S780. doi: 10.4103/jpbs.jpbs_168_22. Epub 2022 Jul 13.'}, {'pmid': '36686996', 'type': 'BACKGROUND', 'citation': 'Ahmed S, Shahnawaz K, Mandal TK, Ghafir M, Gummaluri SS, Vishal G. Comparative Evaluation of Antimicrobial Efficacy of Herbal Formulations of Septilin and Triphala with Conventional 2% Chlorhexidine on Root Canal and Oral Commensal Bacteria using Kirby Bauer Method: An in-vitro Study. Contemp Clin Dent. 2022 Oct-Dec;13(4):383-388. doi: 10.4103/ccd.ccd_423_21. Epub 2022 Nov 8.'}, {'pmid': '36592785', 'type': 'BACKGROUND', 'citation': 'Kumari U, Zafar T, Shafqat S, Askary SH, Qasim M, Kamran MA, Baig EA, Shaikh AC, Qureshi A. Caries-affected dentin disinfection using Triphala, Indocyanine green, and Potassium Titanyl Phosphate laser and their effect on adhesive bond strength. Photodiagnosis Photodyn Ther. 2023 Mar;41:103257. doi: 10.1016/j.pdpdt.2022.103257. Epub 2022 Dec 30.'}, {'pmid': '31149734', 'type': 'BACKGROUND', 'citation': 'Waldron C, Nunn J, Mac Giolla Phadraig C, Comiskey C, Guerin S, van Harten MT, Donnelly-Swift E, Clarke MJ. Oral hygiene interventions for people with intellectual disabilities. Cochrane Database Syst Rev. 2019 May 31;5(5):CD012628. doi: 10.1002/14651858.CD012628.pub2.'}, {'pmid': '30734986', 'type': 'BACKGROUND', 'citation': 'McGrath C, Zhou N, Wong HM. A systematic review and meta-analysis of dental plaque control among children and adolescents with intellectual disabilities. J Appl Res Intellect Disabil. 2019 May;32(3):522-532. doi: 10.1111/jar.12561. Epub 2019 Feb 8.'}, {'pmid': '33067640', 'type': 'BACKGROUND', 'citation': 'Blot S. Antiseptic mouthwash, the nitrate-nitrite-nitric oxide pathway, and hospital mortality: a hypothesis generating review. Intensive Care Med. 2021 Jan;47(1):28-38. doi: 10.1007/s00134-020-06276-z. Epub 2020 Oct 16.'}, {'pmid': '18317557', 'type': 'BACKGROUND', 'citation': 'Biradar YS, Jagatap S, Khandelwal KR, Singhania SS. Exploring of Antimicrobial Activity of Triphala Mashi-an Ayurvedic Formulation. Evid Based Complement Alternat Med. 2008 Mar;5(1):107-13. doi: 10.1093/ecam/nem002.'}, {'pmid': '23422630', 'type': 'BACKGROUND', 'citation': 'Srinagesh J, Krishnappa P, Somanna SN. Antibacterial efficacy of triphala against oral streptococci: an in vivo study. Indian J Dent Res. 2012 Sep-Oct;23(5):696. doi: 10.4103/0970-9290.107423.'}, {'pmid': '25966965', 'type': 'BACKGROUND', 'citation': 'Shanbhag VK. Triphala in prevention of dental caries and as an antimicrobial in oral cavity- a review. Infect Disord Drug Targets. 2015;15(2):89-97. doi: 10.2174/1871526515666150513105009.'}, {'pmid': '27442086', 'type': 'BACKGROUND', 'citation': 'Pradeep AR, Suke DK, Martande SS, Singh SP, Nagpal K, Naik SB. Triphala, a New Herbal Mouthwash for the Treatment of Gingivitis: A Randomized Controlled Clinical Trial. J Periodontol. 2016 Nov;87(11):1352-1359. doi: 10.1902/jop.2016.130406. Epub 2016 Jul 21.'}, {'pmid': '27932522', 'type': 'BACKGROUND', 'citation': 'Mamgain P, Kandwal A, Mamgain RK. Comparative Evaluation of Triphala and Ela Decoction With 0.2% Chlorhexidine as Mouthwash in the Treatment of Plaque-Induced Gingivitis and Halitosis: A Randomized Controlled Clinical Trial. J Evid Based Complementary Altern Med. 2017 Jul;22(3):468-472. doi: 10.1177/2156587216679532. Epub 2016 Dec 8.'}, {'pmid': '24850703', 'type': 'BACKGROUND', 'citation': 'Bhattacharjee R, Nekkanti S, Kumar NG, Kapuria K, Acharya S, Pentapati KC. Efficacy of triphala mouth rinse (aqueous extracts) on dental plaque and gingivitis in children. J Investig Clin Dent. 2015 Aug;6(3):206-10. doi: 10.1111/jicd.12094. Epub 2014 May 22.'}, {'pmid': '24921057', 'type': 'BACKGROUND', 'citation': 'Naiktari RS, Gaonkar P, Gurav AN, Khiste SV. A randomized clinical trial to evaluate and compare the efficacy of triphala mouthwash with 0.2% chlorhexidine in hospitalized patients with periodontal diseases. J Periodontal Implant Sci. 2014 Jun;44(3):134-40. doi: 10.5051/jpis.2014.44.3.134. Epub 2014 Jun 5.'}, {'pmid': '20814522', 'type': 'BACKGROUND', 'citation': 'Tandon S, Gupta K, Rao S, Malagi KJ. Effect of Triphala mouthwash on the caries status. Int J Ayurveda Res. 2010 Apr;1(2):93-9. doi: 10.4103/0974-7788.64413.'}, {'pmid': '22238738', 'type': 'BACKGROUND', 'citation': 'Srinagesh J, Pushpanjali K. Assessment of antibacterial efficacy of triphala against mutans streptococci: a randomised control trial. Oral Health Prev Dent. 2011;9(4):387-93.'}, {'pmid': '28384980', 'type': 'BACKGROUND', 'citation': 'Saxena S, Lakshminarayan N, Gudli S, Kumar M. Anti Bacterial Efficacy of Terminalia Chebula, Terminalia Bellirica, Embilica Officinalis and Triphala on Salivary Streptococcus Mutans Count - A Linear Randomized Cross Over Trial. J Clin Diagn Res. 2017 Feb;11(2):ZC47-ZC51. doi: 10.7860/JCDR/2017/23558.9355. Epub 2017 Feb 1.'}, {'pmid': '21897640', 'type': 'BACKGROUND', 'citation': 'Bajaj N, Tandon S. The effect of Triphala and Chlorhexidine mouthwash on dental plaque, gingival inflammation, and microbial growth. Int J Ayurveda Res. 2011 Jan;2(1):29-36. doi: 10.4103/0974-7788.83188.'}, {'pmid': '28393817', 'type': 'BACKGROUND', 'citation': 'Baratakke SU, Raju R, Kadanakuppe S, Savanur NR, Gubbihal R, Kousalaya PS. Efficacy of triphala extract and chlorhexidine mouth rinse against plaque accumulation and gingival inflammation among female undergraduates: A randomized controlled trial. Indian J Dent Res. 2017 Jan-Feb;28(1):49-54. doi: 10.4103/0970-9290.203622.'}, {'pmid': '29805228', 'type': 'BACKGROUND', 'citation': 'Kayalvizhi G, Nivedha D, Sajeev R, Prathima GS, Suganya M, Ramesh V. Evaluating the Efficacy of Xylitol Wipes on Cariogenic Bacteria in 19- to 35-month-old Children: A Double-blind Randomized Controlled Trial. Int J Clin Pediatr Dent. 2018 Jan-Feb;11(1):13-17. doi: 10.5005/jp-journals-10005-1476. Epub 2017 Feb 1.'}, {'pmid': '16170975', 'type': 'BACKGROUND', 'citation': 'Goyal CR, Qaqish JG, Sharma NC, Warren PR, Cugini M, Thompson MC. Plaque removal efficacy of a novel tooth wipe. J Clin Dent. 2005;16(2):44-6.'}, {'pmid': '33004728', 'type': 'BACKGROUND', 'citation': 'Navya PN, Dhananjaya G, Chandra P. Efficacy of chlorhexidine wipes on colonization of Pseudomonas aeruginosa and Staphylococcus aureus in both ventilator and nonventilator patients in pediatric intensive care unit. J Indian Soc Pedod Prev Dent. 2020 Jul-Sep;38(3):289-292. doi: 10.4103/JISPPD.JISPPD_268_20.'}, {'pmid': '24755196', 'type': 'BACKGROUND', 'citation': 'Ikeda M, Miki T, Atsumi M, Inagaki A, Mizuguchi E, Meguro M, Kanamori D, Nakagawa K, Watanabe R, Mano K, Aihara A, Hane Y, Mutoh T, Matsuo K. Effective elimination of contaminants after oral care in elderly institutionalized individuals. Geriatr Nurs. 2014 Jul-Aug;35(4):295-9. doi: 10.1016/j.gerinurse.2014.03.003. Epub 2014 Apr 20.'}, {'pmid': '33642042', 'type': 'BACKGROUND', 'citation': 'Ryu M, Ueda T, Sakurai K. An Interprofessional Approach to Oral Hygiene for Elderly Inpatients and the Perception of Caregivers Towards Oral Health Care. Int Dent J. 2021 Aug;71(4):328-335. doi: 10.1016/j.identj.2020.12.003. Epub 2021 Feb 25.'}, {'pmid': '35048005', 'type': 'BACKGROUND', 'citation': 'Featherstone JDB, Crystal YO, Alston P, Chaffee BW, Domejean S, Rechmann P, Zhan L, Ramos-Gomez F. Evidence-Based Caries Management for All Ages-Practical Guidelines. Front Oral Health. 2021 Apr 27;2:657518. doi: 10.3389/froh.2021.657518. eCollection 2021.'}, {'pmid': '34441259', 'type': 'BACKGROUND', 'citation': 'Lee E, Park S, Um S, Kim S, Lee J, Jang J, Jeong HO, Shin J, Kang J, Lee S, Jeong T. Microbiome of Saliva and Plaque in Children According to Age and Dental Caries Experience. Diagnostics (Basel). 2021 Jul 23;11(8):1324. doi: 10.3390/diagnostics11081324.'}, {'pmid': '33248211', 'type': 'BACKGROUND', 'citation': 'Qudeimat MA, Alyahya A, Karched M, Behbehani J, Salako NO. Dental plaque microbiota profiles of children with caries-free and caries-active dentition. J Dent. 2021 Jan;104:103539. doi: 10.1016/j.jdent.2020.103539. Epub 2020 Nov 25.'}, {'pmid': '34810345', 'type': 'BACKGROUND', 'citation': 'Patil RU, Nachan VP, Patil SS, Mhaske RV. A clinical trial on topical effect of probiotics on oral Streptococcus mutans counts in children. J Indian Soc Pedod Prev Dent. 2021 Jul-Sep;39(3):279-283. doi: 10.4103/jisppd.jisppd_519_20.'}, {'pmid': '34658377', 'type': 'BACKGROUND', 'citation': 'Latifi-Xhemajli B, Rexhepi A, Veronneau J, Kutllovci T, Ahmeti D, Bajrami S. Streptococcus Mutans Infections in Infants and Related Maternal/Child Factors. Acta Stomatol Croat. 2021 Sep;55(3):308-315. doi: 10.15644/asc55/3/8.'}]}, 'descriptionModule': {'briefSummary': 'This double-blind randomized clinical trial will be conducted among differently abled institutionalized children. Sixty participants aged 6-12 years with mild intellectual disability (ID) will be enrolled in the study and divided into two treatment groups. The participants will be allocated in either of the two treatment arms through Sequentially Numbered, Opaque, Sealed Envelopes (SNOSE) by the principal investigator. One group will receive triphala tooth wipes and the other will be given chlorhexidine tooth wipes, both for 7 days twice a day. Supragingival plaque sample will be collected from the buccal surface of the permanent maxillary first molar and will be subjected to microbial analysis for Streptococcus mutans (S. mutans) colonies using colony-forming units per millilitre (CFU/ml).\n\nThe tooth wipes will be prepared by the principal investigator under supervision of Pharmacognosist at Department of Pharmaceutics and Pharmacognosy, University of Karachi, Pakistan.', 'detailedDescription': "Preparation of Tooth Wipes:\n\nPreparation of Triphala Tooth Wipes- The triphala decoction will be prepared by the principal investigator at Department of Pharmaceutics and Pharmacognosy, University of Karachi, Pakistan under the supervision of Pharmacognocist. The three fruits of triphala will be bought in powder form from an ayurvedic drug vendor. A mixture will be made by combining equal proportion of all these three powders in distilled water. This will then be boiled till the volume reduces to 1/8th part of the initial volume.\n\nA sweetener will be added to the decoction followed by filtering using a white muslin cloth and then storing in a sterile amber-coloured glass bottle in a refrigerator. This will preserve its organoleptic properties and its quality for fourteen days.\n\nThe decoction obtained will be subjected to dilution to obtain concentration. This will then be used to impregnate the marketed tooth wipes fabric. The triphala tooth wipes will be cut, folded individually, and then packed using the wet wipes machine in a plain white packing by local pharmaceutical company. Each pack will contain 16 wipes.\n\nPreparation of Chlorhexidine Tooth Wipes- The commercially available chlorhexidine mouthwash containing will be purchased from the market and will then be used to impregnate the marketed tooth wipes fabric. The chlorhexidine tooth wipes will be cut, folded individually, and then packed using the wet wipes machine in a plain white packing by local pharmaceutical company. Each pack will contain 16 wipes.\n\nData Collection:\n\nConsent- Before initiation of the study, informed consent will be taken from the parent and/or guardian.\n\nProforma- The questionnaire will consist of their demographic details and Intelligence Quotient (IQ) score. The Streptococcus mutans count will be assessed on day 1 and day 7 of the intervention.\n\nIQ Score- Mild ID having IQ score of 50-55 to \\~70 will be part of the study. This IQ score will be provided by the institute's clinical psychologist who examines and score the patient as per American Association of Mental Deficiency (AAMD) criteria.\n\nMicrobial Analysis of the Plaque Sample- Under aseptic measures, the buccal surface of the permanent maxillary first molar will be dried with cotton swab and the supragingival plaque sample will be collected on baseline and Day 7 of the intervention prior to mealtime using sterile Gracey curette 1/2 by the principal investigator. Each of the specimen will be transferred into different sterile Eppendorf tubes having in 0.5 ml phosphate-buffered saline (PBS) to prevent cell rupture or shrinkage due to osmosis. The samples will be transported in an Ice Box. This will be cultured on the mitis salivarius agar with bacitracin in Dow Research Institute of Biotechnology and Biomedical Sciences (DRIBBS) by the microbiologist. The plates will be incubated anaerobically at 37◦C for 48 h for growth of S. mutans colonies will then be assessed at the baseline and on Day 7 of the intervention. The S. mutans count will be classified as Class 0 (none), Class 1 (\\<102), Class 2 (103-104) and Class 3 (10≥5) CFU/ml showing negligible, low, moderate and high caries susceptibility respectively."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Participants with informed consent\n2. Children with mild intellectual disability as per American Association of Mental Deficiency (AAMD)\n3. Age ranging from 6 to 12 years\n4. One treatment group will be thirty children receiving triphala tooth wipes\n5. The other treatment group will be thirty children receiving chlorhexidine tooth wipes\n\nExclusion Criteria:\n\n1. Children who had received antibiotics within 3 months\n2. Participants requiring urgent dental care during the period of study'}, 'identificationModule': {'nctId': 'NCT06575335', 'briefTitle': 'Triphala Tooth Wipes in Reduction of Streptococcus Mutans Colonies', 'organization': {'class': 'OTHER', 'fullName': 'Dow University of Health Sciences'}, 'officialTitle': 'Antibacterial Efficacy of Triphala Tooth Wipes in Reduction of Streptococcus Mutans Colonies in Differently Abled Children- A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'IRB-3384/DUHS/Approval/2024/53'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Triphala Tooth Wipe', 'description': 'The three fruits of triphala (Terminalia chebula, Emblica officinalis and Terminalia bellerica) will be bought in powder form from an herbal drug vendor. A mixture will be made by combining equal proportion of all these three powders in distilled water. This will then be boiled till the volume reduces to 1/8th part of the initial volume. A sweetener will be added to the decoction followed by filtering using a white muslin cloth and then storing in a sterile amber-coloured glass bottle in a refrigerator. The decoction obtained will be subjected to dilution to obtain 0.6% concentration. This will then be used to impregnate the marketed tooth wipes fabric. The triphala tooth wipes will be cut, folded individually, and then packed. Each pack will contain 16 wipes.', 'interventionNames': ['Other: Triphala Tooth Wipe']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Chlorhexidine Tooth Wipe', 'description': 'The commercially available mouthwash containing 0.2% chlorhexidine will be purchased from the market and will then be used to impregnate the marketed tooth wipes fabric. The chlorhexidine tooth wipes will be cut, folded individually, and then packed. Each pack will contain 16 wipes.', 'interventionNames': ['Other: Chlorhexidine Tooth Wipe']}], 'interventions': [{'name': 'Triphala Tooth Wipe', 'type': 'OTHER', 'description': "The wipes will be used 1 hour after meal time, twice daily for consecutively 7 days. The sachet seal will be opened, the wipe will be taken out and rest of the sachet sealed again. The wipes will be unfolded and wrapped around index finger of right hand and all surfaces of child's teeth, gums, roof of the mouth and tongue will be cleaned.", 'armGroupLabels': ['Triphala Tooth Wipe']}, {'name': 'Chlorhexidine Tooth Wipe', 'type': 'OTHER', 'description': 'Same as triphala tooth wipe', 'armGroupLabels': ['Chlorhexidine Tooth Wipe']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Karachi', 'country': 'Pakistan', 'facility': 'Dar-ul-Sukun', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}], 'overallOfficials': [{'name': 'Sana Masood, BDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dow University of Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "As it is confidential data, the investigators won't be sharing it."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dow University of Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sana Masood', 'investigatorAffiliation': 'Dow University of Health Sciences'}}}}