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

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: Not yet recruiting
• Conditions: Crestal Bone Loss
• Intervention / Treatment: Drug: vit D mixed with xenograft; Drug: only xenograft without vit D

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: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: mohamed elsaeed ibrahim, master; Phone Number: +201150315750; Email: mohamedelsaeed683@gmail.com
• 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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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.	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

• Sponsor: Suez Canal University
• Investigators: Principal Investigator: mohamed elsaeed ibrahim, master, Suez Canal University

Study record dates

Study Major Dates

• Study Start (Estimated): July 20, 2025
• Primary Completion (Estimated): July 20, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: June 27, 2025
• First Submitted That Met QC Criteria: July 11, 2025
• First Posted (Actual): July 15, 2025

Study Record Updates

• Last Update Posted (Actual): July 15, 2025
• Last Update Submitted That Met QC Criteria: July 11, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Bone Density Conservation Agents; Micronutrients; Vitamins; Vitamin D; Cholecalciferol
• Other Study ID 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