Osseointegration Failure of Dental ImplantNCT06274216
The Effect of Vitamin D Supplementation on Dental Implant Osseointegration: A Randomized Controlled Trial
A study testing Vitamin D3 and Vitamin E 400 in people with Osseointegration Failure of Dental Implant, run by Ziauddin University at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Osseointegration Failure of Dental Implant
- What is being tested?
- Vitamin D3 and Vitamin E 400
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Sep 2021to 1 Apr 2022
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients of age 18 to 45 years
- Patients of either gender
- Patients undergoing for dental implant
- Patients with Vitamin-D insufficiency
Who cannot join
- Patients with any bone regenerative therapy prior to dental implants
- Patients with arthritis
- Patients with periodontal disease
- Patients with bleeding disorders
- Patients with poor oral hygiene
- Patients with uncontrolled hypertension and diabetes mellitus
Show all 10Show fewer
- Patients with severe vitamin D deficiency
- Patients with chronic renal disease
- Patients on proton pump inhibitors
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the detailed description
Treatment option for replacing lost natural teeth is dental implants. Many factors are essential for the dental implant osse-ointegration, consisting of bone quality and volume, surgical approach and complications and host-associated factors like deficient nutritional status. By influencing bone metabolism, vitamin D, together with calcium, is essential for osseo-integrating implants. The significance of vitamin D supplementation in osseo-integration has received little attention in dental literature; there is little data involving people, and the majority of investigations have used animal models. Due to numerous environmental and dietary factors, international data is not applicable to our population. Latest study shows that 54% of the individuals were vitamin D deficient and 31% had vitamin D insufficiency in Pakistan.(Riaz et al., 2016) As well as Pakistani are less likely to expose to sun due to their full clothing, use of veil and Burqah. This research was therefore assessed the impact of vitamin D supplementation during dental implant osseointegration. In this research, the local data have been generated and dental implants in the presence of vitamin-D supplementation were tested for effectiveness.
- Being tested
- Vitamin D3, Vitamin E 400
- Keywords
- Dental implants, ISQ Value, Osseointegration, Vitamin D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Drug
Also called Sunny-D
5000 IU of vitamin D3 orally every day for 12 weeks
Vitamin E 400Drug
Also called Evion
400mg of vitamin E orally every day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Patients in group A received 5000 IU of vitamin D3 orally every day for 12 weeks Receives: Drug: Vitamin D3 |
| Group B | Active comparator | Patients in group B received 400mg of vitamin E orally every day for 12 weeks Receives: Drug: Vitamin E 400 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Osseo-integration is measured by evaluating the ISQ value (Implant Stability Quotient, ranging from 1-100)
It will assess the difference in osseo-integration among patients undergoing dental implant procedures. Osseo-integration is measured by evaluating the ISQ value (Implant Stability Quotient, ranging from 1-100) using radiographic and clinical assessments with Ostell. A higher ISQ value indicates greater stability of the dental implants in the surrounding bone tissue. The assessment is conducted three months post-implantation, following a period of implant curing.
Measured: 12 weeks
Secondary outcomes (1)
Evaluation of Mean Change in Serum Vitamin D Levels in Dental Implant Patients with and without Vitamin D Supplementation at a Tertiary Care Hospital
The secondary outcome in this study is to measure the mean change in serum vitamin D levels in both groups. This involves assessing how the serum vitamin D levels evolve over the course of the study in both the group receiving vitamin D supplementation and the group receiving a placebo.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start1 Sep 2021
- Primary completion30 Mar 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Osseointegration Failure of Dental ImplantStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ziauddin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Atif Iqbal, Ziauddin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06274216
- Sponsor's protocol ID
- 4381021ABOS
- Status last verified
- Feb 2024
- First submitted
- 18 Jan 2024
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The informed consent process typically outlines the extent to which data will be shared. If participants were not informed about individual data sharing, it may be ethically inappropriate to do so.
Publications
Alsulaimani L, Alqarni A, Almarghlani A, Hassoubah M. The Relationship Between Low Serum Vitamin D Level and Early Dental Implant Failure: A Systematic Review. Cureus. 2022 Jan 15;14(1):e21264. doi: 10.7759/cureus.21264. eCollection 2022 Jan.
PubMed 35178319Munhoz Pereira T, Alvim-Pereira F, Kaiser Alvim-Pereira CC, Ignacio SA, Machado de Souza C, Trevilatto PC. A complete physical mapping of the vitamin D receptor gene for dental implant loss: A pilot study. Clin Oral Implants Res. 2019 Dec;30(12):1165-1178. doi: 10.1111/clr.13529. Epub 2019 Sep 24.
PubMed 31461186Tabrizi R, Mohajerani H, Jafari S, Tumer MK. Does the serum level of vitamin D affect marginal bone loss around dental implants? Int J Oral Maxillofac Surg. 2022 Jun;51(6):832-836. doi: 10.1016/j.ijom.2021.11.006. Epub 2021 Dec 3.
PubMed 34872836Werny JG, Sagheb K, Diaz L, Kammerer PW, Al-Nawas B, Schiegnitz E. Does vitamin D have an effect on osseointegration of dental implants? A systematic review. Int J Implant Dent. 2022 Apr 11;8(1):16. doi: 10.1186/s40729-022-00414-6.
PubMed 35403929Pourshahidi S, Yousefain M. The Relationship Between Serum Level of Vitamin D3 and Osseointegration Around the Dental Implant. J Oral Implantol. 2021 Feb 1;47(1):88-90. doi: 10.1563/aaid-joi-D-19-00341.
PubMed 32663271
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vitamin D Supplementation on Dental Implant Osseointegration: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06274216
- Acronym / sponsor ID
- 4381021ABOS
- Keywords
- Dental implants, ISQ Value, Osseointegration, Vitamin D
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ziauddin UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 23 Feb 2024 (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.
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
Detailed description
Treatment option for replacing lost natural teeth is dental implants. Many factors are essential for the dental implant osse-ointegration, consisting of bone quality and volume, surgical approach and complications and host-associated factors like deficient nutritional status. By influencing bone metabolism, vitamin D, together with calcium, is essential for osseo-integrating implants. The significance of vitamin D supplementation in osseo-integration has received little attention in dental literature; there is little data involving people, and the majority of investigations have used animal models. Due to numerous environmental and dietary factors, international data is not applicable to our population. Latest study shows that 54% of the individuals were vitamin D deficient and 31% had vitamin D insufficiency in Pakistan.(Riaz et al., 2016) As well as Pakistani are less likely to expose to sun due to their full clothing, use of veil and Burqah. This research was therefore assessed the impact of vitamin D supplementation during dental implant osseointegration. In this research, the local data have been generated and dental implants in the presence of vitamin-D supplementation were tested for effectiveness.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Vitamin D3Patients in group A received 5000 IU of vitamin D3 orally every day for 12 weeks |
| Group B | Active comparator | Drug: Vitamin E 400Patients in group B received 400mg of vitamin E orally every day for 12 weeks |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients of age 18 to 45 years
- Patients of either gender
- Patients undergoing for dental implant
- Patients with Vitamin-D insufficiency
Key exclusion criteria (10 listed)
- Patients with any bone regenerative therapy prior to dental implants
- Patients with arthritis
- Patients with periodontal disease
- Patients with bleeding disorders
- Patients with poor oral hygiene
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 |
|---|---|---|
| Vitamin D3Also: Sunny-D5000 IU of vitamin D3 orally every day for 12 weeks | Drug | Group A |
| Vitamin E 400Also: Evion400mg of vitamin E orally every day for 12 weeks | Drug | Group B |
Primary outcome
Osseo-integration is measured by evaluating the ISQ value (Implant Stability Quotient, ranging from 1-100)
Time frame: 12 weeks
It will assess the difference in osseo-integration among patients undergoing dental implant procedures. Osseo-integration is measured by evaluating the ISQ value (Implant Stability Quotient, ranging from 1-100) using radiographic and clinical assessments with Ostell. A higher ISQ value indicates greater stability of the dental implants in the surrounding bone tissue. The assessment is conducted three months post-implantation, following a period of implant curing.
1 secondary outcome
Evaluation of Mean Change in Serum Vitamin D Levels in Dental Implant Patients with and without Vitamin D Supplementation at a Tertiary Care Hospital
Time frame: 12 weeks
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 23 Feb 2024.
- Results publication: PubMed 35178319Alsulaimani L, Alqarni A, Almarghlani A, Hassoubah M. The Relationship Between Low Serum Vitamin D Level and Early Dental Implant Failure: A Systematic Review. Cureus. 2022 Jan 15;14(1):e21264. doi: 10.7759/cureus.21264. eCollection 2022 Jan.
- Results publication: PubMed 31461186Munhoz Pereira T, Alvim-Pereira F, Kaiser Alvim-Pereira CC, Ignacio SA, Machado de Souza C, Trevilatto PC. A complete physical mapping of the vitamin D receptor gene for dental implant loss: A pilot study. Clin Oral Implants Res. 2019 Dec;30(12):1165-1178. doi: 10.1111/clr.13529. Epub 2019 Sep 24.
- Results publication: PubMed 34872836Tabrizi R, Mohajerani H, Jafari S, Tumer MK. Does the serum level of vitamin D affect marginal bone loss around dental implants? Int J Oral Maxillofac Surg. 2022 Jun;51(6):832-836. doi: 10.1016/j.ijom.2021.11.006. Epub 2021 Dec 3.
- Results publication: PubMed 35403929Werny JG, Sagheb K, Diaz L, Kammerer PW, Al-Nawas B, Schiegnitz E. Does vitamin D have an effect on osseointegration of dental implants? A systematic review. Int J Implant Dent. 2022 Apr 11;8(1):16. doi: 10.1186/s40729-022-00414-6.
- Results publication: PubMed 32663271Pourshahidi S, Yousefain M. The Relationship Between Serum Level of Vitamin D3 and Osseointegration Around the Dental Implant. J Oral Implantol. 2021 Feb 1;47(1):88-90. doi: 10.1563/aaid-joi-D-19-00341.
- Individual participant dataSharing planned: No. The informed consent process typically outlines the extent to which data will be shared. If participants were not informed about individual data sharing, it may be ethically inappropriate to do so.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D3 and Vitamin E 400 in people with Osseointegration Failure of Dental Implant, run by Ziauddin University at 1 site in Pakistan.
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 10 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 23 Feb 2024. 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 Pakistan. 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?
Osseo-integration is measured by evaluating the ISQ value (Implant Stability Quotient, ranging from 1-100) (time frame: 12 weeks). 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 NCT06274216, which also lists 5 linked publications.
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 23 Feb 2024.