Partial Edentulism, Dental Implant Placement
Conditions
Keywords
Dental Implant Placement, Advanced Platelet-Rich Fibrin, A-PRF, Hyaluronic Acid, Osseointegration, Implant Stability, Cone-Beam Computed Tomography, Peri-Implant Bone, Bone Formation
Brief 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. 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.
Interventions
PROCEDUREDelayed Dental Implant Placement
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.
DEVICEHyaluronic Acid 1.5%
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.
Sponsors
Samar Ali Abdu Salamah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The CBCT outcome assessor will be blinded to participant group allocation. CBCT images will be coded before assessment so that the assessor cannot identify whether participants belong to the test or control group.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CBCT-Derived Peri-Implant Bone Volume | 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. |
| CBCT-Derived Peri-Implant Radiographic Density | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Implant Stability Quotient (ISQ) | 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. |
| Dental Implant Survival Rate at 6 Months | Up to 6 months after implant placement | 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. |
Countries
Yemen
Contacts
CONTACTSamar A Salamah, BDS
PRINCIPAL_INVESTIGATORSamar A salamah, BDS
Sana'a University
Outcome results
None listed