Actively Recruiting
The Local Effect of Vitamin K2 on Bone Remodeling in Socket Preservation of Mandibular Single Rooted Teeth Randomized Clinical Trial
Led by Cairo University · Updated on 2025-02-05
20
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of socket grafting with crushed vitamin K2 (menaquinone) capsules compared to no grafting on bone density and socket dimensions after tooth extraction. This randomized controlled trial focuses on patients needing extraction of mandibular single-rooted teeth. The study aims to understand how vitamin K2 influences bone remodeling and preservation in the extraction socket. Participants are divided into two groups: the study group receives socket grafting with crushed vitamin K2 capsules covered by an absorbent sponge and stabilized with non-resorbable sutures, while the control group undergoes extraction without grafting but with the socket covered and sutured similarly. Bone density and socket dimensions are measured immediately after extraction and again after 4 months using cone beam computed tomography (CBCT). Core biopsies are also taken at implant placement to analyze new bone formation. During the study, patients will undergo tooth extraction under local anesthesia, with careful cleaning of the socket before treatment. Follow-up assessments include CBCT scans to evaluate bone changes and biopsies at implant placement for detailed bone analysis. The main outcome is marginal bone loss assessed at baseline and after 4 months, with additional measures of implant stability and new bone formation. The total participation duration spans from extraction through the 4-month follow-up and implant placement.
CONDITIONS
Brief Title
The Local Effect of Vitamin K2 on Bone Remodeling in Socket Preservation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years with no other age or gender restrictions
- Patients requiring extraction of mandibular single-rooted teeth
You will not qualify if you...
- Patients with systemic conditions affecting bone metabolism
- Allergies or sensitivities to hydroxyapatite or Vitamin K2
- Untreated or residual periodontal disease
- Uncontrolled diabetes with HbA1c greater than 7.5%
- History of head and/or neck radiotherapy
- Receiving immunosuppressive therapy
- Pregnant or nursing individuals
- Substance abuse
- Current or past treatment with intravenous amino-bisphosphonates
- Participation in other studies if this protocol cannot be followed properly
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure with follow-up assessments over 4 months
Participants undergo tooth extraction under local anesthesia. In the study group, the socket is filled with crushed vitamin K2 capsules and stabilized with sutures. In the control group, the socket is left to heal without grafting and also stabilized with sutures.
1 extraction visit and 2 follow-up visits at baseline and 4 months
Duration - Up to 4 months after extraction
Participants have bone density and socket dimension evaluations using cone beam computed tomography (CBCT) immediately after extraction and at 4 months. At implant placement, a core biopsy is taken for analysis.
2 visits (at 4 months and implant placement)
Trial Site Locations
Total: 1 location
1
Cairo
Cairo, Cairo Governorate, Egypt
Actively Recruiting
Research Team
M
mohamed elsawaf, BDS
M
mohamed Khashaba, Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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