Effect of Advanced PRF and Hyaluronic Acid on Dental Implant Healing
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSamar Ali Abdu Salamah
About this trial
This randomized parallel-group clinical trial aimed to evaluate the clinical efficacy of advanced platelet-rich fibrin (A-PRF) combined with hyaluronic acid (HA) in enhancing peri-implant bone formation in patients undergoing delayed dental implant placement. Participants will be allocated to either a test group, in which A-PRF combined with HA is applied at the implant site, or a control group receiving conventional implant placement without adjunctive biomaterials. Peri-implant bone changes will be assessed using cone-beam computed tomography (CBCT), including radiographic bone density and bone volume measurements. Implant stability will also be evaluated using resonance frequency analysis at the time of implant placement and during follow-up. Additional clinical outcomes include postoperative pain and implant survival. The participants will be followed up for six months after implant placement.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Delayed Dental Implant Placement
Procedure/SurgeryA 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.
Advanced Platelet-Rich Fibrin (A-PRF)
Procedure/SurgeryAutologous 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.
Hyaluronic Acid 1.5%
DeviceIn 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Dental Implant + A-PRF and Hyaluronic AcidExperimental treatment 3 interventions
Group B: Dental Implant AloneActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
CBCT-Derived Peri-Implant Bone Volume
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.
Time frame
Baseline and 6 months after implant placement2
CBCT-Derived Peri-Implant Radiographic Density
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.
Time frame
Baseline and 6 months after implant placementSecondary outcomes
1
Implant Stability Quotient (ISQ)
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.
Time frame
At implant placement and 6 months after implant placement2
Dental Implant Survival Rate at 6 Months
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.
Time frame
Up to 6 months after implant placementSponsors and contacts
Click on the lead sponsor to view all of their trials.
Samar Ali Abdu Salamah
Lead sponsor
Sana'a University
Sponsor institution
Source ClinicalTrials.gov