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

NCT07065877 | Not Yet Recruiting DMC

• 1 other identifier: 961/2025
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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?

Conditions

Crestal Bone Loss

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

vit D mixed with xenograft

ACTIVE COMPARATOR

Topical 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 D

PLACEBO COMPARATOR

grafting the jumping gap with xenograft only around immediate implant

Drug: only xenograft without vit D

Interventions

vit D mixed with xenograft DRUG

Topical application of vitamin D solution mixed with xenograft in the jumping gap around immediate implant

Also known as: cholecalciferol

vit D mixed with xenograft

only xenograft without vit D DRUG

grafting the jumping gap with xenograft only around immediate implant

Also known as: xenotransplant

only xenograft without vit D

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Suez Canal University: lead

Study Sites (1)

oral and maxillofacial surgery depertment of oral and dental medicine faculty Suez canal university

Ismailia, Egypt

Location

MeSH Terms

Interventions

Transplantation, Heterologous; Cholecalciferol

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• mohamed elsaeed ibrahim, master

  Suez Canal University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

mohamed elsaeed ibrahim, master

CONTACT

+201150315750; mohamedelsaeed683@gmail.com

Mohamed Nageh Gad El-Hak, Lecturer

CONTACT

+201002061808

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: master candidate oral and maxillofacial surgery

Model Details: vitamin D solution mixed with xenograft around immediate implant

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: July 15, 2025
• Study Start: July 20, 2025
• Primary Completion (Estimated): July 20, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: July 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)