Evaluation of OMEGA-3 Effect in Alveolar Socket Preservation in Aesthetic Zone
Evaluation of OMEGA-3 Effect in Alveolar Socket Preservation in Aesthetic Zone: A Case Series
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Cairo, Egypt
- Faculty of Dentistry
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients with non-restorable remaining roots.
- Patients free of systemic conditions that might affect the surgical procedure or the quantity or quality of bone (uncontrolled hypertension, uncontrolled diabetes).
Exclusion Criteria:
- Patients below 18 years old
- Patients with hypersensitivity to omega-3, drug formulations or allergic to seafood.
- Pregnant or lactating females
- Patients undergoing chemotherapy or radiotherapy
- Smokers
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Atraumatic extraction for single rooted teeth and placement of omega-3 in the socket
Atraumatic extraction for single rooted teeth in anterior zone and omega-3 polyunsaturated fatty acid placed with collagen sponge inside the extraction socket for socket preservation and implant placement
|
omega-3 fatty acid supplement
Other Names:
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Post-operative pain
Time Frame: immediately after extraction and the second day after extraction
|
Visual Analogue Scale score "VAS score" From 0-10 scores score 0 is no pain which is the best 1-4 is mild pain 5 is moderate pain from 5 -10 pain is getting worse and 10 is the worst
|
immediately after extraction and the second day after extraction
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Radiographic bone changes "horizontal bone changes " using Cone beam CBCT
Time Frame: before extraction and 3months after omega 3 placement
|
Performing one CBCT before extraction and one new CBCT after 3 months of extraction and omega-3 placement then comparing both CBCTs by J image computer program to get the difference in vertical bone measurements in millimeter
|
before extraction and 3months after omega 3 placement
|
|
Radiographic bone changes " Vertical bone fill" using CBCT
Time Frame: before and after 3 months of extraction and omega-3 placement
|
Performing one CBCT before extraction and one new CBCT after 3 months of extraction and omega-3 placement then comparing both CBCTs by J image computer program to get the difference in vertical bone measurements in millimeter
|
before and after 3 months of extraction and omega-3 placement
|
|
Radiographic bone changes "Bone density" using CBCT
Time Frame: 3 months after extraction and placement of omega-3
|
Performing one CBCT before extraction and one new CBCT after 3 months of extraction and omega-3 placement then comparing both CBCTs by J image computer program to get the radiographic bone changes in millimeter and Hounsfield units
|
3 months after extraction and placement of omega-3
|
|
Histological examination
Time Frame: after 3months of extraction during implant placement bone is taken using trephine bur
|
using Hematoxylin and Eosin staining to measure the area of newly formed bone "Percentage"
|
after 3months of extraction during implant placement bone is taken using trephine bur
|
|
Healing Index "HI" by Landry et al using scores
Time Frame: after 3months of omega 3 placement
|
Using Landry et al wound healing index to measure soft tissue reaction changes.
Each category is scored from 1 to 5, with 1 indicating very poor healing and 5 indicating excellent healing.
The HI is a useful tool for assessing the quality of wound healing and guiding postoperative interventions.
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after 3months of omega 3 placement
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Collaborators and Investigators
Sponsor
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 30122024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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