Effect of Vitamin D on Crestal Bone Loss Around Immediate Implant After Mandibular Premolars and Molars Extraction (vitD)

July 11, 2025 updated by: Mohamed elsaeed, Suez Canal University

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?

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Mohamed Nageh Gad El-Hak, Lecturer
  • Phone Number: +201002061808

Study Locations

  • Egypt
      • Ismailia, Egypt
        • oral and maxillofacial surgery depertment of oral and dental medicine faculty Suez canal university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: vit D mixed with xenograft
Topical application of vitamin D solution mixed with xenograft in the jumping gap around immediate implant
Drug: vit D mixed with xenograft
Topical application of vitamin D solution mixed with xenograft in the jumping gap around immediate implant
Other Names:
  • cholecalciferol
Placebo Comparator: only xenograft without vit D
grafting the jumping gap with xenograft only around immediate implant
Drug: only xenograft without vit D
grafting the jumping gap with xenograft only around immediate implant
Other Names:
  • xenotransplant

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Suez Canal University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: mohamed elsaeed ibrahim, master, Suez Canal University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 20, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 20, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 27, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 15, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 961/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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