Effect of Advanced PRF and Hyaluronic Acid on Dental Implant Healing
Clinical Efficacy of A-PRF With Hyaluronic Acid" in Enhancing Bone Formation in Dental Implantation
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Samar A Salamah, BDS
- Phone Number: +967777277949
- Email: samarali777277949@gmail.com
Study Locations
-
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Sana'a
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Sanaa, Sana'a, Yemen
- Recruiting
- Beauty Smile Dental Center
-
Contact:
- Samar A Salamah, BDS
- Phone Number: +967777277949
- Email: samarali777277949@gmail.com
-
Contact:
- Samar A Salamah, BDS
- Email: samarali777277949@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults aged 18-65 years.
Patients requiring delayed dental implant placement in a posterior mandibular edentulous site
Sufficient residual alveolar bone height and width to permit conventional implant placement without the need for simultaneous guided bone regeneration (GBR), ridge augmentation, or other bone-grafting procedures.
Good general health or a medically controlled and stable systemic condition compatible with elective implant surgery and not expected to materially compromise wound or bone healing.
Non-smokers with no current use of tobacco products.
Acceptable oral hygiene and a periodontal condition compatible with implant surgery following any required professional treatment and reassessment.
Ability and willingness to undergo the required clinical and radiographic assessments, including CBCT examinations at baseline and at the 6-month follow-up.
Ability and willingness to attend the scheduled follow-up visits and comply with the study procedures.
Provision of written informed consent before study participation.
Exclusion Criteria:
-
Any uncontrolled systemic disease or medical condition that conensions for conventional implant placement without augmentation.
Requirement for immediate implant placement, simultaneous guided bone regeneration, ridge augmentation, or any other adjunctive bone-grafting procedure.
Inability or unwillingness to complete the required 6-month clinical and radiographic follow-up.traindicates elective implant surgery or may substantially impair wound or bone healing, including uncontrolled diabetes mellitus.
Immunocompromised status or current systemic immunosuppressive therapy.
Current or previous use of oral or parenteral bisphosphonates or other antiresorptive medications associated with a risk of medication-related osteonecrosis of the jaw.
Pregnancy at the time of screening or enrollment.
Unresolved active periodontal disease or active local infection involving the intended implant site, including suppuration.
Inadequate oral hygiene that persists after professional oral-hygiene instruction, necessary periodontal treatment, and reassessment.
Insufficient residual alveolar bone dim
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Dental Implant + A-PRF and Hyaluronic Acid
Participants receive delayed dental implant placement with adjunctive application of advanced platelet-rich fibrin (A-PRF) combined with hyaluronic acid at the implant site.
|
A dental implant was surgically placed into a healed edentulous site using a standardized delayed-placement protocol.
This procedure was performed in both the test and control groups.
Autologous advanced platelet-rich fibrin (A-PRF) was prepared from the participants' venous blood using a standardized centrifugation protocol and applied at the dental implant site.
In the test group, A-PRF was used in combination with hyaluronic acid as an adjunct to delayed dental implant placement.
In the test group, 1.5% hyaluronic acid is combined with autologous advanced platelet-rich fibrin (A-PRF) and applied locally at the dental implant site during delayed dental implant placement.
The control group does not receive hyaluronic acid.
|
|
Active Comparator: Dental Implant Alone
Participants receive delayed dental implant placement without adjunctive A-PRF or hyaluronic acid.
|
A dental implant was surgically placed into a healed edentulous site using a standardized delayed-placement protocol.
This procedure was performed in both the test and control groups.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
CBCT-Derived Peri-Implant Bone Volume
Time Frame: Baseline and 6 months after implant placement
|
The peri-implant bone volume will be assessed using cone-beam computed tomography (CBCT) at baseline and 6 months after dental implant placement.
Changes in bone volume between baseline and the 6-month follow-up will be evaluated and compared between the test and control groups.
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Baseline and 6 months after implant placement
|
|
CBCT-Derived Peri-Implant Radiographic Density
Time Frame: Baseline and 6 months after implant placement
|
Peri-implant radiographic density will be assessed using cone-beam computed tomography (CBCT) at baseline and 6 months after dental implant placement.
Changes in radiographic density between baseline and the 6-month follow-up will be evaluated and compared between the test and control groups.
|
Baseline and 6 months after implant placement
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Implant Stability Quotient (ISQ)
Time Frame: At implant placement and 6 months after implant placement
|
Implant stability will be assessed using resonance frequency analysis and expressed as Implant Stability Quotient (ISQ) values.
ISQ will be measured at the time of implant placement and at the 6-month follow-up, and changes will be compared between the test and control groups.
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At implant placement and 6 months after implant placement
|
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Dental Implant Survival Rate at 6 Months
Time Frame: Up to 6 months after implant placement
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Implant survival will be assessed by determining whether the dental implant remains in situ and clinically functional without removal during the 6-month follow-up period.
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Up to 6 months after implant placement
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Samar A salamah, BDS, Sana'a University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- OMFS-033\06\2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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