Back to resultsEffect of Topical Application of Hyaluronic Acid on Stability of Immediate Loading Dental Implant in Posterior Maxilla
Primary Purpose
Missing Teeth
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Hyaluronic acid
conventional implant placement
Sponsored by
About this trial
This is an interventional other trial for Missing Teeth focused on measuring Hyaluronic Acid, dental implant
Eligibility Criteria
Inclusion Criteria:
- Highly motivated patients with good oral hygiene.
- Age 18 years or older.
- Adequate alveolar bone volume at the implant site, at least 6mm in width and 15 mm in height.
- Free from any parafunctional habits
Exclusion Criteria:
- Patients suffering from any systemic or local disease that contraindicate implant placement or surgery.
- Pregnancy.
- Smokers.
Sites / Locations
- Merna Elhadidi
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
control
Hyaluronic acid
Arm Description
Each implant was placed into the prepared implant site.
Each implant was placed after topical application of HA on its surface
Outcomes
Primary Outcome Measures
implant stability
using radiofrequency analysis
implant stability
using radiofrequency analysis
implant stability
using radiofrequency analysis
implant stability
using radiofrequency analysis
bone density
bone density around the implant is measured in cone beam computed tomography
Secondary Outcome Measures
propping depth
The distance between the gingival margin and the base of the pocket
bleeding inex
Modified sulcus bleeding index
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05403099
Brief Title
Effect of Topical Application of Hyaluronic Acid on Stability of Immediate Loading Dental Implant in Posterior Maxilla
Official Title
Effect of Topical Application of Hyaluronic Acid on Stability of Immediate Loading Dental Implant in Posterior Maxilla
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
March 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Effect of Topical Application of Hyaluronic Acid on Stability of Immediate Loading Dental Implant in Posterior Maxilla
Detailed Description
Patients were randomly divided into two groups:
Group I (Control group):
Ten implants were placed in posterior maxilla and immediately loaded.
Group II (Study group):
Ten implants were coated with HA before placement in posterior maxilla and immediately loaded.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Missing Teeth
Keywords
Hyaluronic Acid, dental implant
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Twenty implants were inserted in patients seeking for replacement of missed single or multiple posterior maxillary teeth. Patients were divided randomly into two groups. In the control group, ten implants were placed and immediately loaded. While in the study group, ten implants were coated with hyaluronic acid (HA) immediately before placement and immediately loaded. All patients were clinically evaluated at implant placement time, one, three and six months after loading regarding implant stability. Peri-implant pocket depth and modified sulcus bleeding index were evaluated clinically at six months in all patients. Bone density was evaluated radiographically after three months. All clinical and radiographic data were subjected to statistical analysis.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control
Arm Type
Active Comparator
Arm Description
Each implant was placed into the prepared implant site.
Arm Title
Hyaluronic acid
Arm Type
Experimental
Arm Description
Each implant was placed after topical application of HA on its surface
Intervention Type
Other
Intervention Name(s)
Hyaluronic acid
Intervention Description
immediate placement of dental implant after topical application of hyaluronic acid on implant surface
Intervention Type
Other
Intervention Name(s)
conventional implant placement
Intervention Description
immediate placement of dental implant without application of hyaluronic acid on implant surface
Primary Outcome Measure Information:
Title
implant stability
Description
using radiofrequency analysis
Time Frame
immediately after surgery
Title
implant stability
Description
using radiofrequency analysis
Time Frame
one month
Title
implant stability
Description
using radiofrequency analysis
Time Frame
three months
Title
implant stability
Description
using radiofrequency analysis
Time Frame
six months
Title
bone density
Description
bone density around the implant is measured in cone beam computed tomography
Time Frame
three months
Secondary Outcome Measure Information:
Title
propping depth
Description
The distance between the gingival margin and the base of the pocket
Time Frame
six months
Title
bleeding inex
Description
Modified sulcus bleeding index
Time Frame
six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Highly motivated patients with good oral hygiene.
Age 18 years or older.
Adequate alveolar bone volume at the implant site, at least 6mm in width and 15 mm in height.
Free from any parafunctional habits
Exclusion Criteria:
Patients suffering from any systemic or local disease that contraindicate implant placement or surgery.
Pregnancy.
Smokers.
Facility Information:
Facility Name
Merna Elhadidi
City
Mansoura
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Topical Application of Hyaluronic Acid on Stability of Immediate Loading Dental Implant in Posterior Maxilla
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