Partial EdentulismNCT07792720
Effect of Advanced PRF and Hyaluronic Acid on Dental Implant Healing
A study testing Delayed Dental Implant Placement, Advanced Platelet-Rich Fibrin (A-PRF) and Hyaluronic Acid 1.5% in people with Partial Edentulism and Dental Implant Placement, run by Samar Ali Abdu Salamah at 1 site in Yemen.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Partial Edentulism, Dental Implant Placement
- What is being tested?
- Delayed Dental Implant Placement, Advanced Platelet-Rich Fibrin (A-PRF) and Hyaluronic Acid 1.5%
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteYemen
- Study dates
- 5 Jun 2025to Jun 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- -
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yemen1 site, 1 recruiting
- Recruiting
Beauty Smile Dental Center
Sanaa, Sana'a
Samar A Salamah, BDS, +967777277949, samarali777277949@gmail.com
Samar A Salamah, BDS, samarali777277949@gmail.com
About this study
Official title: Clinical Efficacy of A-PRF With Hyaluronic Acid" in Enhancing Bone Formation in Dental Implantation
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.
- Conditions
- Partial Edentulism, Dental Implant Placement
- Being tested
- Delayed Dental Implant Placement, Advanced Platelet-Rich Fibrin (A-PRF), Hyaluronic Acid 1.5%
- Keywords
- Dental Implant Placement, Advanced Platelet-Rich Fibrin, A-PRF, Hyaluronic Acid, Osseointegration, Implant Stability, Cone-Beam Computed Tomography, Peri-Implant Bone, Bone Formation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delayed Dental Implant PlacementProcedure or surgery
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.
Advanced Platelet-Rich Fibrin (A-PRF)Procedure or surgery
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.
Hyaluronic Acid 1.5%Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Dental Implant + A-PRF and Hyaluronic Acid | Experimental | Participants receive delayed dental implant placement with adjunctive application of advanced platelet-rich fibrin (A-PRF) combined with hyaluronic acid at the implant site. Receives: Procedure: Delayed Dental Implant Placement; Procedure: Advanced Platelet-Rich Fibrin (A-PRF); Device: Hyaluronic Acid 1.5% |
| Dental Implant Alone | Active comparator | Participants receive delayed dental implant placement without adjunctive A-PRF or hyaluronic acid. Receives: Procedure: Delayed Dental Implant Placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 6 months after implant placement
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.
Measured: Baseline and 6 months after implant placement
Secondary outcomes (2)
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.
Measured: At implant placement and 6 months after implant placement
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.
Measured: Up to 6 months after implant placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start5 Jun 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partial EdentulismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized to either the test group, receiving A-PRF combined with hyaluronic acid during dental implant placement, or the control group, receiving conventional dental implant placement.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samar Ali Abdu Salamah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Samar Ali Abdu Salamah, Sana'a University
- Investigators
- Samar A salamah, BDS, Principal investigator, Sana'a University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07792720
- Sponsor's protocol ID
- OMFS-033\06\2025
- Status last verified
- Aug 2026
- First submitted
- 25 Aug 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because no formal data-sharing plan was included in the approved study protocol or informed consent. Study findings will be disseminated through scientific publication and presentation in aggregate form.