protocolSection identificationModule nctId: NCT06274216, orgStudyIdInfo id: 4381021ABOS, briefTitle: The Effect of Vitamin D Supplementation on Dental Implant Osseointegration: A Randomized Controlled Trial, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-09-01, primaryCompletionDateStruct date: 2022-03-30, completionDateStruct date: 2022-04-01, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Ziauddin University, class: OTHER, descriptionModule briefSummary: Dental implantation is a new technique for the single or more missing tooth replacement. Dental professionals might utilize the findings of this investigation to generate local data and learn more about how vitamin D affects bone metabolism and implant osseo-integration. The long-term success of dental implants would also be enhanced and preserved with the right medical use of vitamin D, conditionsModule conditions: Osseointegration Failure of Dental Implant, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The research commences through a self-administered questionnaire such as age, gender, weight, height, BMI, smoking habits, sun exposure, and employment status.Prior to implant surgery, each participant undergoes a blood test to assess their vitamin D levels.Detailed records are maintained concerning the anatomical position (molar, pre-molar, canine, and incisor) and implant site (maxilla and mandible) for every participant.Group Formation: The participant pool is stratified into two distinct groups - Group A and Group B. This categorization is essential for implementing and comparing different interventions within the study. Group A undergoes a specific intervention wherein they receive a daily oral dose of 5000 IU of vitamin D3 for a duration of 12 weeks. In contrast, Group B receives a placebo.Following the intervention period, the implants are allowed to cure adequately, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, maskingDescription: Groups A and B were created out of all patients who had signed up. Patients in group A received 5000 IU of vitamin D3 orally every day for 12 weeks, whereas patients in group B received a placebo. Patients were blinded to the study medication. The implants were then allowed to cure adequately and submerged for a further three months. Patients were summoned back three months later to un-cover the implant.The both groups were compared for the difference of osseo-integration at 3 months, as well as difference of osseo-integration were compared with respect to implant site (maxilla and mandible).Additionally, change in vitamin D levels were also assessed pre-operatively and post-operatively at 3 months., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 100, type: ACTUAL, armsInterventionsModule interventions name: Vitamin D3, interventions name: Vitamin E 400, outcomesModule primaryOutcomes measure: Osseo-integration is measured by evaluating the ISQ value (Implant Stability Quotient, ranging from 1-100), secondaryOutcomes measure: Evaluation of Mean Change in Serum Vitamin D Levels in Dental Implant Patients with and without Vitamin D Supplementation at a Tertiary Care Hospital, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: ADULT, contactsLocationsModule locations facility: Afifa Razi, city: Karachi, state: Sindh, zip: 74700, country: Pakistan, geoPoint lat: 24.8608, lon: 67.0104, hasResults: False