- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05403099
Effect of Topical Application of Hyaluronic Acid on Stability of Immediate Loading Dental Implant in Posterior Maxilla
June 1, 2022 updated by: Mansoura University
Effect of Topical Application of Hyaluronic Acid on Stability of Immediate Loading Dental Implant in Posterior Maxilla
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Mansoura, Egypt
- Merna Elhadidi
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 56 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: control
Each implant was placed into the prepared implant site.
|
immediate placement of dental implant without application of hyaluronic acid on implant surface
|
|
Experimental: Hyaluronic acid
Each implant was placed after topical application of HA on its surface
|
immediate placement of dental implant after topical application of hyaluronic acid on implant surface
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
implant stability
Time Frame: immediately after surgery
|
using radiofrequency analysis
|
immediately after surgery
|
|
implant stability
Time Frame: one month
|
using radiofrequency analysis
|
one month
|
|
implant stability
Time Frame: three months
|
using radiofrequency analysis
|
three months
|
|
implant stability
Time Frame: six months
|
using radiofrequency analysis
|
six months
|
|
bone density
Time Frame: three months
|
bone density around the implant is measured in cone beam computed tomography
|
three months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
propping depth
Time Frame: six months
|
The distance between the gingival margin and the base of the pocket
|
six months
|
|
bleeding inex
Time Frame: six months
|
Modified sulcus bleeding index
|
six months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2019
Primary Completion (Actual)
March 1, 2020
Study Completion (Actual)
March 1, 2020
Study Registration Dates
First Submitted
May 20, 2022
First Submitted That Met QC Criteria
June 1, 2022
First Posted (Actual)
June 3, 2022
Study Record Updates
Last Update Posted (Actual)
June 3, 2022
Last Update Submitted That Met QC Criteria
June 1, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Congenital Abnormalities
- Stomatognathic Diseases
- Periodontal Diseases
- Mouth Diseases
- Tooth Diseases
- Stomatognathic System Abnormalities
- Tooth Abnormalities
- Tooth Loss
- Anodontia
- Physiological Effects of Drugs
- Immunologic Factors
- Protective Agents
- Adjuvants, Immunologic
- Viscosupplements
- Hyaluronic Acid
Other Study ID Numbers
- 01010119
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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