Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202607687611415 Date of Registration: 24/07/2026
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Topical Application of Vitamin D3 gel to Implant Surfaces Prior to Placement During Lateral Maxillary Sinus Augmentation: A Clinical Comparative Study
Official scientific title Topical Application of Vitamin D3 gel to Implant Surfaces Prior to Placement During Lateral Maxillary Sinus Augmentation: A Clinical Comparative Study
Brief summary describing the background and objectives of the trial Maxillary sinus augmentation is a predictable procedure for implant placement in the atrophic posterior maxilla; however, enhancing bone regeneration remains a clinical challenge. This clinical study evaluated the effect of topical vitamin D3 gel to implant surfaces before placement during lateral maxillary sinus augmentation. Thirty patients requiring sinus augmentation with simultaneous implant placement were randomly assigned to either a vitamin D3 group or a control group. Clinical and radiographic evaluations included implant stability, bone density, bone gain. Both groups demonstrated successful osseointegration. However, the vitamin D3 group showed significantly greater implant stability, higher bone density, and greater bone gain compared with the control group. No complications related to the use of topical vitamin D3 gel were observed during the follow-up period. The findings of this research suggest that topical vitamin D3 may enhance bone regeneration and implant stability when used as an adjunct during maxillary sinus augmentation with simultaneous implant placement.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) N/A
Disease(s) or condition(s) being studied Oral Health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial
Anticipated trial start date 18/02/2024
Actual trial start date 07/04/2024
Anticipated date of last follow up 07/02/2026
Actual Last follow-up date 07/02/2026
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 30
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Topical vitamin D3 gel applied to implant surfaces Aِ standardized volume of sterile calcitriol (vitamin D3) gel applied once to completely cover the implant surface immediately before implant placement. Single application during surgery Participants undergo lateral maxillary sinus augmentation with simultaneous dental implant placement. Before implant insertion, the implant surface is completely coated with a standardized volume of sterile topical vitamin D3 (calcitriol) gel. Sinus augmentation is performed using a mineralized plasmatic matrix (MPM) combined with xenograft. 15
Control Group MPM mixed with Xenograft No topical vitamin D3 applied Single surgical procedure Participants undergo lateral maxillary sinus augmentation with simultaneous dental implant placement using a mineralized plasmatic matrix (MPM) combined with xenograft. No topical vitamin D3 is applied to the implant surface. 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• 3- 5mm residual bone height. • Missing one or more maxillary posterior teeth. • Adequate inter-arch space. • Co-operative patients. • Uncontrolled systemic conditions affect bone healing or surgery. • Parafunction habits such as bruxism and clenching. • Patients with any pathological conditions related to site of surgery. • Heavy smokers. • Patients with chronic or acute infection in the maxillary sinus. Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 35 Year(s) 57 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 18/02/2024 Faculty of Dental Medicine Al Azhar University Assiut Branch
Ethics Committee Address
Street address City Postal code Country
Faculty of Dental Medicine for Boys, Al Azhar University, Assiut Branch Assiut 71524 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Implant stability measured by damping capacity assessment (DCA). will be assessed using the AnyCheck implant stability measuring device immediately after implant placement T0 and six months postoperatively T6.
Primary Outcome Bone density assessed using cone-beam computed tomography . Cone-beam computed tomography examinations will be performed immediately after surgery T0, at six months T6, and at nine months T9.
Primary Outcome Vertical bone gains following maxillary sinus augmentation. Measurements will be obtained at T0, T6, and T9 .
Secondary Outcome Evaluate the clinical safety of topical Vitamin D3 gel by recording any treatment-related adverse events or postoperative complications. throughout the follow-up period.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Dental Medicine Al Azhar University Faculty of Dental Medicine for Boys , Assiut Branch, Al-Azhar University Assiut Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Eslam Abdelaziz Sadek Aboelhassan Sohag, Egypt sohag City Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Eslam Abdelaziz Sadek Aboelhassan Sohag Sohag Egypt Self-sponsored researcher
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Eslam Abdelaziz Sadek Aboelhassan eslam_abdelaziz_post@med.sohag.edu.eg 0201097937788 Sohag
City Postal code Country Position/Affiliation
Sohag Egypt BDS M.Sc OMFS General Administration of Medical Affairs Sohag University Sohag Egypt
Role Name Email Phone Street address
Public Enquiries Eslam Abdelaziz Sadek Aboelhassan eslam_abdelaziz_post@med.sohag.edu.eg 0201097937788 Sohag
City Postal code Country Position/Affiliation
Sohag Egypt BDS M.Sc. OMFS General Administration of Medical Affairs Sohag University Sohag Egypt
Role Name Email Phone Street address
Scientific Enquiries Eslam Abdelaziz Sadek Aboelhassan eslam_abdelaziz_post@med.sohag.edu.eg 0201097937788 Sohag
City Postal code Country Position/Affiliation
Sohag Egypt BDS M.Sc. OMFS General Administration of Medical Affairs Sohag University Sohag Egypt
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes De-identified individual participant data underlying the results reported in this study will be made available upon reasonable request to the corresponding investigator. Informed Consent Form,Statistical Analysis Plan,Study Protocol Beginning 12 months after publication and ending 5 years after publication Data will be available to qualified researchers upon reasonable request for scientifically sound research purposes, subject to approval by the principal investigator and institutional regulations.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 18/07/2026 The approval date was corrected to match the official Research Ethics Committee approval letter. The previous date was entered incorrectly during the initial registration. TRUE, Faculty of Dental Medicine Al Azhar University Assiut Branch, Faculty of Dental Medicine for Boys, Al Azhar University, Assiut Branch, Assiut, 71524, Egypt, , 14 Feb 2024, 0882181056, aadj@azhar.edu.eg, 43688_40013_4737.pdf TRUE, Faculty of Dental Medicine Al Azhar University Assiut Branch, Faculty of Dental Medicine for Boys, Al Azhar University, Assiut Branch, Assiut, 71524, Egypt, , 18 Feb 2024, 0882181056, aadj@azhar.edu.eg, 43688_40013_4737.pdf