Crestal Bone LossvitDNCT07065877
Effect of Vitamin D on Crestal Bone Loss Around Immediate Implant After Mandibular Premolars and Molars Extraction
A study testing vit D mixed with xenograft and only xenograft without vit D in people with Crestal Bone Loss, run by Suez Canal University at 1 site in Egypt.
Trial summary
What is the difference between grafting the jumping gap upon using xenograft mixed with topical vitamin D clinically regarding crestal bone level and implant stability, radiographically regarding crestal bone level after implant insertion in the posterior region of mandible? Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Crestal Bone Loss
- What is being tested?
- vit D mixed with xenograft and only xenograft without vit D
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jul 2025to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The American Society of Anesthesiologist (ASA) I , II
- Both Genders. 3- Patients having unrestorable tooth on the posterior mandibular region
- Age>20
- The patient who have complete their facial growth and teeth eruption
- No bone disease or lesion in propose implant site
Who cannot join
- Poor oral hygiene patients and/or patients
- Patients with active acute infection.
- Patients with bad oral habits.
- Pregnant or lactating women.
- Heavy smokers.
- Alcohol and drug addicts.
- Diabetes disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mohamed Nageh Gad El-Hak, Lecturer contact
Egypt1 site
oral and maxillofacial surgery depertment of oral and dental medicine faculty Suez canal university
Ismailia
About this study
Official title: Clinical and Radiographic Assessment Of Immediate Implant With Topical Vitamin D and Xenograft Mixture: A Randomized Controlled Study
What is the difference between grafting the jumping gap upon using xenograft mixed with topical vitamin D clinically regarding crestal bone level and implant stability, radiographically regarding crestal bone level after implant insertion in the posterior region of mandible?
Read the detailed description
Effect of Vitamin D on Bone Regeneration .Vitamin D is known for its role in the skeletal system. Vit D deficiency is also widely researched for its effects on the healing of fractures, bone defects and osseointegration of implants. There are studies that investigated the effects of dietary supplementation with vitamin D to reduce vitamin D deficiency but increasing the serum level of this vitamin takes time therefore, an attempt has been made to combat the effect of vitamin D deficiency through topical application. up to the knowledge, upon search of literatures, there is not enough studies that correlate topical application of vitamin D with xenograft mixture as filling space material. this study is to Assess immediate implant with topical vitamin D and xenograft mixture clinically and Radiographically.
- Conditions
- Crestal Bone Loss
- Being tested
- vit D mixed with xenograft, only xenograft without vit D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vit D mixed with xenograftDrug
Also called cholecalciferol
Topical application of vitamin D solution mixed with xenograft in the jumping gap around immediate implant
only xenograft without vit DDrug
Also called xenotransplant
grafting the jumping gap with xenograft only around immediate implant
| Study group | Role | What they receive |
|---|---|---|
| vit D mixed with xenograft | Active comparator | Topical application of vitamin D solution mixed with xenograft in the jumping gap around immediate implant Receives: Drug: vit D mixed with xenograft |
| only xenograft without vit D | Placebo comparator | grafting the jumping gap with xenograft only around immediate implant Receives: Drug: only xenograft without vit D |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinically: A)Loss of crestal bone. B)Stability of implant. Radiographically: crestal bone loss by periapical radiograph in millimeters.
the loss of crestal bone after implant insertion using periodontal probe in millimeters.
implant stability using OSTELL device. Postoperative follow up using periapical radiographs to evaluate crestal bone loss in millimeters will be after, one ,three months and six months by standardized parallel periapical digital technique radiograph .The radiographs will be done by using: The Kavo Scan eXamTM One and the Rinn extension cone paralleling (XCP)periapical film holder will be used to achieve standardization of digital radiographs.
Measured: clinically: Loss of crestal bone by periodontal prop assessed in millimeters in six months Stability of implant by OSTTEL assessed as ISQ values in six months crestal bone loss in millimeters will be one ,three months and six months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start20 Jul 2025 (estimated)
- Primary completion20 Jul 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crestal Bone LossStudies 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
- Model description
- vitamin D solution mixed with xenograft around immediate implant
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed elsaeed, Suez Canal University
- Investigators
- mohamed elsaeed ibrahim, master, Principal investigator, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07065877
- Sponsor's protocol ID
- 961/2025
- Acronym
- vitD
- Status last verified
- Jun 2025
- First submitted
- 27 Jun 2025
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Assessment Of Immediate Implant With Topical Vitamin D and Xenograft Mixture: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07065877
- Acronym / sponsor ID
- vitD / 961/2025
- Conditions
- Crestal Bone Loss
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 20 Jul 2025 (estimated)
- Primary completion
- 20 Jul 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 15 Jul 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.
What is the difference between grafting the jumping gap upon using xenograft mixed with topical vitamin D clinically regarding crestal bone level and implant stability, radiographically regarding crestal bone level after implant insertion in the posterior region of mandible?
Detailed description
Effect of Vitamin D on Bone Regeneration .Vitamin D is known for its role in the skeletal system. Vit D deficiency is also widely researched for its effects on the healing of fractures, bone defects and osseointegration of implants. There are studies that investigated the effects of dietary supplementation with vitamin D to reduce vitamin D deficiency but increasing the serum level of this vitamin takes time therefore, an attempt has been made to combat the effect of vitamin D deficiency through topical application. up to the knowledge, upon search of literatures, there is not enough studies that correlate topical application of vitamin D with xenograft mixture as filling space material. this study is to Assess immediate implant with topical vitamin D and xenograft mixture clinically and Radiographically.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- vitamin D solution mixed with xenograft around immediate implant
| Arm | Type | Receives |
|---|---|---|
| vit D mixed with xenograft | Active comparator | Drug: vit D mixed with xenograftTopical application of vitamin D solution mixed with xenograft in the jumping gap around immediate implant |
| only xenograft without vit D | Placebo comparator | Drug: only xenograft without vit Dgrafting the jumping gap with xenograft only around immediate implant |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- The American Society of Anesthesiologist (ASA) I , II
- Both Genders. 3- Patients having unrestorable tooth on the posterior mandibular region
- Age>20
- The patient who have complete their facial growth and teeth eruption
- No bone disease or lesion in propose implant site
Key exclusion criteria (7 listed)
- Poor oral hygiene patients and/or patients
- Patients with active acute infection.
- Patients with bad oral habits.
- Pregnant or lactating women.
- Heavy smokers.
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 |
|---|---|---|
| vit D mixed with xenograftAlso: cholecalciferolTopical application of vitamin D solution mixed with xenograft in the jumping gap around immediate implant | Drug | vit D mixed with xenograft |
| only xenograft without vit DAlso: xenotransplantgrafting the jumping gap with xenograft only around immediate implant | Drug | only xenograft without vit D |
Primary outcome
clinically: A)Loss of crestal bone. B)Stability of implant. Radiographically: crestal bone loss by periapical radiograph in millimeters.
Time frame: clinically: Loss of crestal bone by periodontal prop assessed in millimeters in six months Stability of implant by OSTTEL assessed as ISQ values in six months crestal bone loss in millimeters will be one ,three months and six months.
the loss of crestal bone after implant insertion using periodontal probe in millimeters. implant stability using OSTELL device. Postoperative follow up using periapical radiographs to evaluate crestal bone loss in millimeters will be after, one ,three months and six months by standardized parallel periapical digital technique radiograph .The radiographs will be done by using: The Kavo Scan eXamTM One and the Rinn extension cone paralleling (XCP)periapical film holder will be used to achieve standardization of digital radiographs.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Crestal Bone Loss
Active, not recruiting
Influence of Implant Insertion Depth on Peri-implant Bone Changes Around Short Implants
Tooth Loss, Edentulism
Not yet recruiting
Influence of Acetal Resin Versus Nylon Elastic Cap on Crestal Bone Loss in Mandibular Implant-Supported Overdenture
Bone Loss, Pocket, Periodontal
Recruiting
Investigating Implant Surface Effect on Osseointegration: NGA vs. ModSLA
Dental Implant
Not yet recruiting
Clinical and Radiographic Evaluation of CGF and Alloplastic Grafting in Participants Undergoing the Socket Shield Technique for Immediate Anterior Maxillary Implant Placement. This Study Assesses Bone Healing and Stability When Managing the Crestal Gap in the Esthetic Zone.
Alveolar Ridge Resorption, Bone Loss in the Esthetic Zone
Recruiting
Influence of Vertical Implant Position on Marginal Bone Loss in Cases With Thin Phenotype
Vertical Implant Position, Delayed Implant Placement With Immediate Loading
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.
Mohamed Nageh Gad El-Hak, Lecturer contact
mohamed elsaeed ibrahim, master 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 vit D mixed with xenograft and only xenograft without vit D in people with Crestal Bone Loss, 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 5 inclusion and 7 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: opening soon, as of the sponsor's last update on 15 Jul 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact mohamed elsaeed ibrahim, master (+201150315750, mohamedelsaeed683@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinically: A)Loss of crestal bone. B)Stability of implant. Radiographically: crestal bone loss by periapical radiograph in millimeters. (time frame: clinically: Loss of crestal bone by periodontal prop assessed in millimeters in six months Stability of implant by OSTTEL assessed as ISQ values in six months crestal bone loss in millimeters will be one ,three months and six months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jul 2025.