The Local Effect of Vitamin K2 on Bone Remodeling in Socket Preservation
ConditionSocket Preservation
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorCairo University
About this trial
This study is a randomized controlled trial comparing the effects of socket grafting with crushed vitamin K2 (menaquinone)capsules versus no grafting on bone density and socket dimensions following tooth extraction. Patients are randomly assigned to one of two groups:
Study Group (Group I): Patients receive socket grafting with crushed vitamin K2 (menaquinone) capsules. The socket is covered with an absorbent sponge, and non-resorbable sutures are placed to stabilize the graft material and achieve soft tissue stability.
Control Group (Group II): Patients undergo socket healing without grafting. The socket is covered with an absorbent sponge, and non-resorbable sutures are placed over it.
Outcome measures include bone socket dimensions evaluated immediately after extraction with graft material, as well as assessment after 4 months using cone beam computed tomography (CBCT) radiographs. Additionally, core biopsies are taken at the time of implant placement.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients requiring extraction of mandibular single-rooted teeth.
Disqualifiers
• Patients with systemic conditions affecting bone metabolism.
Allergies or sensitivities to hydroxyapatite or Vitamin K2
Untreated or residual periodontal disease;
Uncontrolled diabetes (HbA1c > 7.5%);
Trial design
Design model
Parallel
Treatments tested in this trial
Menaquinone
Drugthe socket will be filled with crushed capsule of vitamin k2 menaquinone in study group
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Menaquinone groupActive comparator 1 intervention
Group B: control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Marginal bone loss
At the time of extraction, CBCT imaging will provide baseline data on the initial bone structure This baseline measurement serves as a reference point for evaluating any subsequent changes in bone density and morphology. After four months, another CBCT scan will be conducted to assess the amount of marginal bone loss that has occurred since the initial extraction. By comparing the post-extraction CBCT images with those taken after four months, researchers can quantify any changes in bone volume and identify any areas of concern related to bone resorption. The unit of measurement for the primary outcome, vertical bone change (socket height), is millimeters (mm).
Time frame
baseline and 4 month after extractionSecondary outcomes
1
Primary stability
For the primary stability assessment, the Implant Stability Quotient (ISQ) will be utilized. ISQ is a non-invasive and widely used method for evaluating the initial stability of dental implants during placement. Unit of Measurement: Implant Stability Quotient (ISQ)
Time frame
at time of implant placment2
amount of new bone formation
amount of new bone formation," histomorphometric analysis will be employed. This method involves the microscopic examination and quantification of bone tissue characteristics to assess the extent of bone formation. Histomorphometric analysis allows researchers to evaluate the quality and quantity of newly formed bone in the extraction site or implantation site. It involves taking tissue samples (biopsies) from the area of interest and then processing these samples for microscopic examination. Unit of Measurement: Bone area percentage (%)
Time frame
baseline and 4 month after extractionOther outcomes
1
Secondary stability
the Implant Stability Quotient (ISQ) will be utilized. ISQ is a non-invasive and widely used method for evaluating the stability. Unit of Measurement: Implant Stability Quotient (ISQ)
Time frame
4 month post-implant placementSponsors and contacts
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Source ClinicalTrials.gov