Immediate Dental ImplantNCT06806423
Clinical and Radiographic Evaluation of Topical Vitamin D on Immediate Dental Implants
A study testing Immediate Dental Implant Placement without Adjunctive Treatments and Immediate Dental Implant Placement with Topical Vitamin D Gel Application in people with Immediate Dental Implant and Implant Osseointegration, run by Suez Canal University at 1 site in Egypt.
Trial summary
This study evaluates the clinical and radiographic outcomes of topical vitamin D application on immediate dental implants in patients undergoing single-rooted tooth extraction in the anterior mandibular region. Read more about this study
- Who is it for?
- Ages 21 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Immediate Dental Implant, Implant Osseointegration, Vitamin D
- What is being tested?
- Immediate Dental Implant Placement without Adjunctive Treatments and Immediate Dental Implant Placement with Topical Vitamin D Gel Application
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Oct 2022to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Both genders.
- Middle-aged adults (from 21 years to 40 years).
- Healthy American Society of Anesthesiologists patients (ASA I).
- Patients with teeth or roots indicated for extraction at the lower anterior region.
Who cannot join
- Pregnant or lactating females.
- Patients with parafunctional or bad oral habits such as bruxism or smoking (more than 10 cigarettes per day).
- Patients with bad oral hygiene.
- Patients with severe periodontal diseases (severe vertical or horizontal bone loss).
- Pathological changes or infections related to teeth indicated for immediate implant placement.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Oral & Maxillofacial Surgery Department, Faculty of Dentistry, Suez Canal University
Ismailia, Ismailia Governorate, 41522
About this study
Official title: Clinical and Radiographic Evaluation of Topical Vitamin D Application on Immediate Dental Implants: a Randomized Clinical Trial
This study evaluates the clinical and radiographic outcomes of topical vitamin D application on immediate dental implants in patients undergoing single-rooted tooth extraction in the anterior mandibular region.
Read the detailed description
This randomized clinical trial investigates the clinical and radiographic outcomes of topical vitamin D application on immediate dental implants in patients undergoing single-rooted tooth extraction in the anterior mandibular region. Osseointegration, the direct structural and functional connection between bone and implant surface, is a critical factor in implant success. Recent studies suggest that vitamin D3 plays a significant role in bone metabolism, promoting osteoblast differentiation and enhancing mineralization. The aim of this study is to evaluate whether the adjunctive use of topical vitamin D3 gel can improve implant stability, peri-implant soft tissue health, and bone density around immediate dental implants.
Surgical Protocol:
- All surgical procedures were performed under strict infection control protocols at the Faculty of Dentistry, Suez Canal University.
- Patients rinsed with 0.1% chlorhexidine (Hexitol antiseptic mouthwash) for one minute before the procedure.
- The perioral area was disinfected using 10% povidone-iodine (Betadine).
- Local anesthesia was administered using 4% articaine hydrochloride with 1:100,000 epinephrine (Artinibsa) via the infiltration technique.
- Atraumatic tooth extractions were performed using periotomes and anterior forceps, preserving the surrounding alveolar bone.
- The dimensions of the extraction socket and residual bone were evaluated using a periodontal probe to ensure compatibility with the implant size.
- Osteotomy preparation followed a standardized protocol using sequential drills at 950-1100 rpm with 35 Ncm torque under copious irrigation to prevent overheating and bone necrosis.
- Study Group: Sterile vitamin D3 (calcitriol) gel was applied to both the implant surface and the osteotomy site immediately before implant placement.
- Control Group: No additional adjuncts were applied before implant placement.
- ROOTT R-line implants were selected based on socket dimensions.
- Implants were inserted into fresh extraction sockets, and proper alignment was meticulously confirmed to ensure ideal positioning.
Postoperative and Follow-up Evaluations:
- Clinical Assessments:
- Pain levels were measured using the Visual Analog Scale (VAS) on postoperative days 1, 3, and 7.
- Probing depth and bleeding index were recorded at 3 and 6 months to assess peri-implant soft tissue health.
- Implant stability was evaluated using the Osstell ISQ device at baseline, 3 months, and 6 months.
- Radiographic Assessments:
- Standardized digital periapical radiographs were taken at baseline, 3 months, and 6 months to monitor bone density changes around the implants.
- Bone density analysis was performed using IDRISI Kilimanjaro software, which measured grayscale values to provide quantitative bone density assessments.
- Being tested
- Immediate Dental Implant Placement without Adjunctive Treatments, Immediate Dental Implant Placement with Topical Vitamin D Gel Application
- Keywords
- Immediate dental implants, Calcitriol, 1,25-dihydroxycholecalciferol, Osseointegration, Implant stability, Bone density, IDRISI Kilimanjaro software
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate Dental Implant Placement without Adjunctive TreatmentsProcedure or surgery
Atraumatic extractions using periotomes and anterior forceps. Osteotomy was prepared with a standardized drilling sequence under copious irrigation. ROOTT R-line implants were selected based on socket dimensions. No topical vitamin D3 was applied. Implants were placed into fresh extraction sockets.
Immediate Dental Implant Placement with Topical Vitamin D Gel ApplicationProcedure or surgery
The same procedure as the control group, with the addition of sterile topical vitamin D3 (calcitriol) gel applied to both the implant surface and osteotomy site immediately before implant placement.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | 12 implants were placed immediately after teeth extraction. Receives: Procedure: Immediate Dental Implant Placement without Adjunctive Treatments |
| Vitamin D Group | Experimental | 12 implants were placed immediately after teeth extraction, combined with topical vitamin D gel application. Receives: Procedure: Immediate Dental Implant Placement with Topical Vitamin D Gel Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant Stability (ISQ)
Implant stability was measured using the Osstell ISQ device, providing precise, non-invasive, and objective assessments for monitoring osseointegration. A SmartPeg was securely attached to the implant, and a probe connected to the device was positioned at a right angle toward the implant. The Implant Stability Quotient (ISQ) was measured on a scale from 1 to 100, with values above 70 indicating high stability, 60-69 indicating medium stability, and values below 60 suggesting low stability. Stability was assessed immediately after surgery and then reassessed at 3 and 6 months.
Measured: Baseline, 3, and 6 months postoperatively
Bone Density
Radiographic evaluations were conducted using direct digital periapical radiographs, captured with the KaVo Scan eXam™ One system and Rinn XCP device. Radiographs were taken immediately postoperatively, and at 3 and 6 months. Bone density around the implants was analyzed using IDRISI Kilimanjaro software, which measured grayscale values to quantify density. Bone density was quantified on a 255-point grayscale, with 0 representing black regions and 255 representing white regions. Two zones were assessed: the osseointegration zone adjacent to the implant and the surrounding bone. This approach provided precise monitoring of bone density changes over time.
Measured: Baseline, 3 and 6 months postoperatively
Secondary outcomes (3)
Peri-implant Probing Depth (PD)
Peri-implant probing depth was measured to assess the soft tissue healing surrounding the implants. A periodontal probe was gently inserted into the space between the implant healing abutments and the soft tissue at six sites: mesio-buccal, buccal, disto-buccal, mesio-palatal, palatal, and disto-palatal. Measurements were taken at 3 and 6 months postoperatively. The depth, recorded in millimeters, provided a numerical index of peri-implant tissue health, with shallow depths indicating healthy tissues and deeper pockets suggesting potential peri-implant disease. This straightforward method allowed for a comprehensive evaluation of implant sites over time.
Measured: 3 and 6 months postoperatively
Bleeding Index (BI)
The Bleeding Index was used to assess the soft tissue healing surrounding the implants. A periodontal probe was gently inserted into the space between the implant healing abutments and the soft tissue at six sites: mesio-buccal, buccal, disto-buccal, mesio-palatal, palatal, and disto-palatal. Measurements were taken at 3 and 6 months postoperatively. The presence or absence of bleeding at these sites served as an indicator of tissue health, with bleeding suggesting inflammation or compromised healing, and no bleeding indicating healthy soft tissues. This method provided valuable insights into the status of soft tissue healing around the implants.
Measured: 3 and 6 months postoperatively
Visual Analogue Scale for Pain (VAS)
The VAS is a commonly used questionnaire for measuring pain intensity. It consists of a 10-centimeter horizontal line with endpoints labeled to represent the extremes of pain, typically "no pain" on the left and "unimaginably unspeakable pain" or similar descriptors on the right. Patients are asked to mark a point on the line that reflects their current level of pain. The distance in centimeters from the "no pain" end to the patient's mark provides a numerical value representing the severity of their pain, offering a simple and quantifiable method for pain assessment.
Measured: Days 1, 3, and 7 postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start11 Oct 2022
- Primary completion1 Jan 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Immediate Dental ImplantStudies of the same condition, open and under way.
- More trials run by Suez Canal UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bassem M. Ayyad, Suez Canal University
- Investigators
- Bassem M. Ayyad, Principal investigator, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06806423
- Sponsor's protocol ID
- Vit D on Dental Implants
- Status last verified
- Feb 2025
- First submitted
- 28 Jan 2025
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ayyad BM, Hamed MS, Elrody A, Hanna PA, Younis AA. Clinical and radiographic evaluation of topical vitamin D application on immediate dental implants: a randomized clinical trial. BMC Oral Health. 2025 Jul 5;25(1):1114. doi: 10.1186/s12903-025-06465-6.
PubMed 40618145
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Topical Vitamin D Application on Immediate Dental Implants: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06806423
- Acronym / sponsor ID
- Vit D on Dental Implants
- Keywords
- Immediate dental implants, Calcitriol, 1,25-dihydroxycholecalciferol, Osseointegration, Implant stability, Bone density, IDRISI Kilimanjaro software
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 11 Oct 2022 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 4 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the clinical and radiographic outcomes of topical vitamin D application on immediate dental implants in patients undergoing single-rooted tooth extraction in the anterior mandibular region.
Detailed description
This randomized clinical trial investigates the clinical and radiographic outcomes of topical vitamin D application on immediate dental implants in patients undergoing single-rooted tooth extraction in the anterior mandibular region. Osseointegration, the direct structural and functional connection between bone and implant surface, is a critical factor in implant success. Recent studies suggest that vitamin D3 plays a significant role in bone metabolism, promoting osteoblast differentiation and enhancing mineralization. The aim of this study is to evaluate whether the adjunctive use of topical vitamin D3 gel can improve implant stability, peri-implant soft tissue health, and bone density around immediate dental implants.
Surgical Protocol:
- All surgical procedures were performed under strict infection control protocols at the Faculty of Dentistry, Suez Canal University.
- Patients rinsed with 0.1% chlorhexidine (Hexitol antiseptic mouthwash) for one minute before the procedure.
- The perioral area was disinfected using 10% povidone-iodine (Betadine).
- Local anesthesia was administered using 4% articaine hydrochloride with 1:100,000 epinephrine (Artinibsa) via the infiltration technique.
- Atraumatic tooth extractions were performed using periotomes and anterior forceps, preserving the surrounding alveolar bone.
- The dimensions of the extraction socket and residual bone were evaluated using a periodontal probe to ensure compatibility with the implant size.
- Osteotomy preparation followed a standardized protocol using sequential drills at 950-1100 rpm with 35 Ncm torque under copious irrigation to prevent overheating and bone necrosis.
- Study Group: Sterile vitamin D3 (calcitriol) gel was applied to both the implant surface and the osteotomy site immediately before implant placement.
- Control Group: No additional adjuncts were applied before implant placement.
- ROOTT R-line implants were selected based on socket dimensions.
- Implants were inserted into fresh extraction sockets, and proper alignment was meticulously confirmed to ensure ideal positioning.
Postoperative and Follow-up Evaluations:
- Clinical Assessments:
- Pain levels were measured using the Visual Analog Scale (VAS) on postoperative days 1, 3, and 7.
- Probing depth and bleeding index were recorded at 3 and 6 months to assess peri-implant soft tissue health.
- Implant stability was evaluated using the Osstell ISQ device at baseline, 3 months, and 6 months.
- Radiographic Assessments:
- Standardized digital periapical radiographs were taken at baseline, 3 months, and 6 months to monitor bone density changes around the implants.
- Bone density analysis was performed using IDRISI Kilimanjaro software, which measured grayscale values to provide quantitative bone density assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Procedure: Immediate Dental Implant Placement without Adjunctive Treatments12 implants were placed immediately after teeth extraction. |
| Vitamin D Group | Experimental | Procedure: Immediate Dental Implant Placement with Topical Vitamin D Gel Application12 implants were placed immediately after teeth extraction, combined with topical vitamin D gel application. |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Both genders.
- Middle-aged adults (from 21 years to 40 years).
- Healthy American Society of Anesthesiologists patients (ASA I).
- Patients with teeth or roots indicated for extraction at the lower anterior region.
Key exclusion criteria (5 listed)
- Pregnant or lactating females.
- Patients with parafunctional or bad oral habits such as bruxism or smoking (more than 10 cigarettes per day).
- Patients with bad oral hygiene.
- Patients with severe periodontal diseases (severe vertical or horizontal bone loss).
- Pathological changes or infections related to teeth indicated for immediate implant placement.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immediate Dental Implant Placement without Adjunctive TreatmentsAtraumatic extractions using periotomes and anterior forceps. Osteotomy was prepared with a standardized drilling sequence under copious irrigation. ROOTT R-line implants were selected based on socket dimensions. No topical vitamin D3 was applied. Implants were placed into fresh extraction sockets. | Procedure or surgery | Control Group |
| Immediate Dental Implant Placement with Topical Vitamin D Gel ApplicationThe same procedure as the control group, with the addition of sterile topical vitamin D3 (calcitriol) gel applied to both the implant surface and osteotomy site immediately before implant placement. | Procedure or surgery | Vitamin D Group |
Primary outcome
Implant Stability (ISQ)
Time frame: Baseline, 3, and 6 months postoperatively
Implant stability was measured using the Osstell ISQ device, providing precise, non-invasive, and objective assessments for monitoring osseointegration. A SmartPeg was securely attached to the implant, and a probe connected to the device was positioned at a right angle toward the implant. The Implant Stability Quotient (ISQ) was measured on a scale from 1 to 100, with values above 70 indicating high stability, 60-69 indicating medium stability, and values below 60 suggesting low stability. Stability was assessed immediately after surgery and then reassessed at 3 and 6 months.
Bone Density
Time frame: Baseline, 3 and 6 months postoperatively
Radiographic evaluations were conducted using direct digital periapical radiographs, captured with the KaVo Scan eXam™ One system and Rinn XCP device. Radiographs were taken immediately postoperatively, and at 3 and 6 months. Bone density around the implants was analyzed using IDRISI Kilimanjaro software, which measured grayscale values to quantify density. Bone density was quantified on a 255-point grayscale, with 0 representing black regions and 255 representing white regions. Two zones were assessed: the osseointegration zone adjacent to the implant and the surrounding bone. This approach provided precise monitoring of bone density changes over time.
3 secondary outcomes
Peri-implant Probing Depth (PD)
Time frame: 3 and 6 months postoperatively
Bleeding Index (BI)
Time frame: 3 and 6 months postoperatively
Visual Analogue Scale for Pain (VAS)
Time frame: Days 1, 3, and 7 postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Derived from this study: PubMed 40618145Ayyad BM, Hamed MS, Elrody A, Hanna PA, Younis AA. Clinical and radiographic evaluation of topical vitamin D application on immediate dental implants: a randomized clinical trial. BMC Oral Health. 2025 Jul 5;25(1):1114. doi: 10.1186/s12903-025-06465-6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bassem M. Ayyad principal investigator
Suez Canal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate Dental Implant Placement without Adjunctive Treatments and Immediate Dental Implant Placement with Topical Vitamin D Gel Application in people with Immediate Dental Implant and Implant Osseointegration, run by Suez Canal University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant Stability (ISQ) (time frame: Baseline, 3, and 6 months postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06806423, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025.