Nctid:
NCT06223243
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D003773", "term"=>"Dental Plaque"}], "ancestors"=>[{"id"=>"D003741", "term"=>"Dental Deposits"}, {"id"=>"D014076", "term"=>"Tooth Diseases"}, {"id"=>"D009057", "term"=>"Stomatognathic Diseases"}], "browseLeaves"=>[{"id"=>"M6970", "name"=>"Dental Plaque", "asFound"=>"Dental Plaque", "relevance"=>"HIGH"}, {"id"=>"M6938", "name"=>"Dental Deposits", "relevance"=>"LOW"}, {"id"=>"M16831", "name"=>"Tooth Diseases", "relevance"=>"LOW"}, {"id"=>"M12017", "name"=>"Stomatognathic Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Mouth and Tooth Diseases", "abbrev"=>"BC07"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D002710", "term"=>"Chlorhexidine"}], "ancestors"=>[{"id"=>"D000891", "term"=>"Anti-Infective Agents, Local"}, {"id"=>"D000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D004202", "term"=>"Disinfectants"}], "browseLeaves"=>[{"id"=>"M5953", "name"=>"Chlorhexidine", "asFound"=>"Twice a day", "relevance"=>"HIGH"}, {"id"=>"M344731", "name"=>"Chlorhexidine gluconate", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}, {"id"=>"M4215", "name"=>"Anti-Infective Agents, Local", "relevance"=>"LOW"}, {"id"=>"M7383", "name"=>"Disinfectants", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Dermatologic Agents", "abbrev"=>"Derm"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"TRIPLE", "whoMasked"=>["PARTICIPANT", "INVESTIGATOR", "OUTCOMES_ASSESSOR"], "maskingDescription"=>"Tthe assessor was not involved in the mouthrinse assignment. Besides, the bottles were covered to prevent from showing the color of mouthrinse."}, "primaryPurpose"=>"PREVENTION", "interventionModel"=>"PARALLEL", "interventionModelDescription"=>"randomised clinical trial, blinded and performed in 3 parallel groups."}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>30}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2023-03-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2024-01-01", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-01-22", "studyFirstSubmitDate"=>"2023-02-16", "studyFirstSubmitQcDate"=>"2024-01-22", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2023-09-01", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"plaque score", "timeFrame"=>"three days", "description"=>"plaque accumulation level will be measured using dichotomous scoring system ( 1- presence of plaque and 0- absence of plaque) for each 4 sites in each tooth. The scoring will be added and divided by total number of sites, and results in a percentage (plaque score)."}], "secondaryOutcomes"=>[{"measure"=>"patients' acceptance", "timeFrame"=>"3 days", "description"=>"patients' acceptance on mouthrinse in terms of halitosis, taste, odour and burning sensation were recorded using visual analogue scale whereby 1 indicates worst experience while 10 indicates best experience."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Plaque Accumulation", "Patient Acceptance"]}, "descriptionModule"=>{"briefSummary"=>"Mouthrinses are recommended as a complement to mechanical methods in oral hygiene procedures to prevent and control periodontal diseases. Chlorhexidine mouthrinse has been used as a chemical plaque control agent for many years. However, in spite of its potent antimicrobial and antiplaque properties, there have been various reports of the undesirable adverse effects of chlorhexidine mouthrinse. This creates the need to look for an alternative mouthrinse that can also help in controlling plaque.\n\nStingless bee honey is an alternative agent which is increasingly known for its better properties and easily available compared to other types of honey. It has been reported to have many benefits for the oral cavity such as antibacterial, anti-inflammatory, and healing properties which makes it a potential therapeutic agent in periodontal therapy. However, there is a lack of clinical studies showing its efficacy in plaque control as a mouthrinse.\n\nHence, this study aims to investigate the ability of stingless bee honey mouthrinse to reduce plaque accumulation. This will be done through a randomised clinical trial whereby subjects will be prescribed with a mouthrinse formulation and instructed to refrain from any tooth cleaning procedure. The patient's plaque score will be recorded before and after the intervention to measure the effectiveness of the mouthrinse.", "detailedDescription"=>"Objectives:\n\ni. To investigate the patients' plaque level after use of stingless bee honey mouthrinse in a clinical trial. ii. To investigate patients' acceptance to stingless bee honey mouthrinse. iii. To compare plaque level after use of stingless bee honey mouthrinse to chlorhexidine mouthrinse.\n\nThis is a randomised, double-blinded, placebo-controlled clinical study that will be conducted at the Faculty of Dentistry, Universiti Sains Islam Malaysia (USIM). Application of ethical approval will be made to USIM's medical ethical committee of the Faculty of Medicine and Health Science.\n\nPatients who seek scaling and polishing treatment at Faculty of Dentistry, USIM were invited to participate in study. Written and informed consent were obtained from the participants. As this is a pilot study, sample size calculation was not performed. A total of ten participants per group were recruited for the study.\n\nPre-intervention, plaque score and BPE were taken at baseline by a single clinician (NAH), a periodontist. This was to reduce any variation in plaque score recording between different clinicians. Both the patients and the clinician were blinded to the intervention given to reduce bias. After recording the plaque score, scaling and prophylaxis were performed by periodontists (NAH, NHMB \\& MAS). This was to ensure that all participants start at an equal oral hygiene level and that the score taken after three days will be purely from plaque formation and not from the negligence of oral hygiene.\n\nThree different mouthrinse formulations were prepared for this study: (1) stingless bee honey-based mouthrinse (Bayu kelulut ®) containing honey diluted with distilled water to a concentration of 1:1, (2) 0.12% chlorhexidine (Oradex Antibacterial Mouthwash, Malaysia. Reg no: MAL06011901XCZ), and (3) placebo (negative control) containing saline solution. The Malaysian stingless bee honey, Bayu Kelulut ® is a product certified by Malaysian Good Manufacturing Practices and Malaysian Agricultural Research and Development Institute (MARDI), and chlorhexidine is registered under the National Pharmaceutical Regulatory Agency, Ministry of Health. These mouthrinse preparations were packed, sealed and coded in identical bottles before starting the study.\n\n60ml of mouthrinse in a sealed bottle were prescribed by two dental students at random. These formulations were mixed in Laboratory level 18, Faculty of Dentistry, Universiti Sains Islam Malaysia and kept in the refrigerator between 2-8°C. Patients were instructed to refrain from all forms of tooth cleaning and rinse 10ml of mouthrinse twice daily for two minutes. This was done in three days.\n\nAfter three days, the same clinician (NAH) measured the plaque score and BPE again. Prophylaxis were given."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT"], "maximumAge"=>"40 years", "minimumAge"=>"18 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n1. Medically healthy participants aged between 18-40\n2. Healthy gingiva or localised gingivitis with the highest Basic Periodontal Examination (BPE) score of 2\n3. Presence of at least 20 natural teeth\n\nExclusion Criteria:\n\n1. Diabetes\n2. Physical and/or mental disabilities that may interfere with receiving mouthrinse instructions\n3. Orthodontic or prosthodontic appliances\n4. Undergoing antibiotic/antimicrobial therapy\n5. Current smoker\n6. Abnormal saliva secretion rate\n7. Pregnancy\n8. Allergy to honey or bee stings"}, "identificationModule"=>{"nctId"=>"NCT06223243", "briefTitle"=>"The Effect of Stingless Bee Honey Mouthrinse on Dental Plaque Accumulation", "organization"=>{"class"=>"OTHER", "fullName"=>"Universiti Sains Islam Malaysia"}, "officialTitle"=>"The Effect of Stingless Bee Honey Mouthrinse on Dental Plaque Accumulation", "orgStudyIdInfo"=>{"id"=>"SBH Mouthrinse"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"stingless bee honey", "description"=>"stingless bee honey mouthrinse was prescribed to participants assigned to this group.", "interventionNames"=>["Other: Stingless bee honey mouthrinse"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"chlorhexidine", "description"=>"chlorhexidine mouthrinse was prescribed to participants assigned to this group.", "interventionNames"=>["Other: chlorhexidine mouthrinse"]}, {"type"=>"PLACEBO_COMPARATOR", "label"=>"normal saline", "description"=>"Normal saline mouthrinse was prescribed to participants assigned to this group.", "interventionNames"=>["Other: normal saline mouthrinse"]}], "interventions"=>[{"name"=>"Stingless bee honey mouthrinse", "type"=>"OTHER", "description"=>"Three bottles of 90ml of stingless bee honey of 20% concentration was given to each subject. This mouthrinse preparation was instructed for subjects to be taken 30ml each, thrice daily for three days.", "armGroupLabels"=>["stingless bee honey"]}, {"name"=>"normal saline mouthrinse", "type"=>"OTHER", "description"=>"Subjects were instructed to rinse with 30ml of normal saline (0.9% concentration) thrice daily for three days.", "armGroupLabels"=>["normal saline"]}, {"name"=>"chlorhexidine mouthrinse", "type"=>"OTHER", "description"=>"Subjects were instructed to rinse with 30ml of chlorhexidine mouthrinse thrice daily for three days.", "armGroupLabels"=>["chlorhexidine"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"55100", "city"=>"Kuala Lumpur", "state"=>"Pandan Indah", "country"=>"Malaysia", "facility"=>"Students Dental Clinic, Faculty of Dentistry, University Sains Islam Malaysia.", "geoPoint"=>{"lat"=>3.1412, "lon"=>101.68653}}], "overallOfficials"=>[{"name"=>"NUR AYMAN ABDUL HAYEI", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"FACULTY OF DENTISTRY, UNIVERSITI SAINS ISLAM MALAYSIA"}]}, "ipdSharingStatementModule"=>{"infoTypes"=>["STUDY_PROTOCOL"], "timeFrame"=>"Two years", "ipdSharing"=>"YES", "description"=>"The IPD might be shared if it would expand the results of the study."}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Universiti Sains Islam Malaysia", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Clinical Lecturer", "investigatorFullName"=>"NUR AYMAN ABDUL HAYEI", "investigatorAffiliation"=>"Universiti Sains Islam Malaysia"}}}}
