Crestal Bone Loss, Dental Implant, Keratinized Mucosa, Platelet Rich Fibrin
Conditions
Keywords
Platelet-Rich Fibrin (PRF), Dental Implant, Keratinized Mucosa, Crestal Bone Level, Soft Tissue Healing
Brief summary
The present investigation seeks to determine how varying quantities of Platelet-Rich Fibrin (PRF) membranes influence the repair of both gingival and osseous tissues adjacent to dental implants. A secondary objective is to establish whether the incorporation of PRF contributes to enhanced stability of the soft-tissue cover and more effective retention of alveolar bone over an extended period. Central to the study are two specific inquiries: Does the application of PRF correlate with an increase in the width and thickness of keratinized mucosa surrounding the implant? Is there a dose-response relationship such that the use of multiple PRF layers yields superior maintenance of bone height compared with a single layer or no PRF at all? To address these questions, clinicians will juxtapose three treatment groups: one receiving no PRF, another receiving a single membrane, and a third receiving a triple-layer graft. Healing parameters will be measured before surgery and again at 6-week and 12-week checkpoints, allowing direct appraisal of outcome changes across the comparative cohorts. Each participant will ultimately be allotted to one of the experimental arms by random assignment, thus mitigating selection bias. Routine follow-up examinations and radiographic imaging, will be used to track healing progress.
Interventions
PROCEDUREDental implant placement without PRF
Standard dental implant placement procedure with flap elevation and suturing, without the application of any PRF membrane over the implant site.
BIOLOGICALSingle-layer PRF membrane application
PRF membrane prepared via centrifugation is applied as a single layer over the implant site following implant placement before flap closure.
BIOLOGICALTriple-layer PRF membrane application
Three autologous PRF membranes prepared via centrifugation are stacked and applied as a 3-layer membrane over the implant site before flap closure.
Sponsors
Al-Mustansiriyah University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcomes assessor was blinded to the group allocation to prevent bias during the evaluation of soft tissue width and crestal bone measurements.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Adults (male or female) over 18 years of age. * Partially edentulous spaces. * No history of bone augmentation procedures in the implant site. * Good oral health, as measured by: * Calibrated gingival bleeding index (≤10%) * O'Leary plaque index (\<10%)
Exclusion criteria
* Bleeding disorders. * Compromised immune systems. * Excessive smoking or alcohol consumption. * Poor oral hygiene. * Diabetes. * Inability to attend follow-up visits.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Crestal Bone Height (BH) | Immediate postoperative, 6 weeks, and 12 weeks | Measured in millimeters on periapical radiographs using digital software from the second serration on the mesial side of the implant to the crest of the bone. |
| Keratinized Tissue Thickness (KTT) | Baseline (preoperative), and 12 weeks postoperatively | Measured in millimeters at the buccal, crestal and lingual reference points using a periodontal probe and a digital vernier caliper. |
| Radiographic Mucosal Thickness (RT) | Baseline (preoperative), immediate postoperative, 6 weeks, and 12 weeks | Measured in millimeters on periapical radiographs using digital software from the crestal bone level to the crest of crestal oral mucosa 5 mm away from the height distal surface of the adjacent tooth on the mesial side of the implant. |
| Ridge Width Changes (RW) | Baseline (preoperative), immediate postoperative, 6 weeks, and 12 weeks | The changes in Ridge Width is measured at the reference points using a digital vernier caliper. |
| Bone Width (BW) | Baseline (preoperative), and 12 weeks postoperatively | Measured in millimeters by subtracting the buccal and lingual mucosal thickness from the ridge width. |
| Change in width of keratinized tissue (KTW) | Baseline (preoperative), 6 weeks, and 12 weeks | Measured in millimeters at the mid-buccal aspect of the implant site using an endodontic rotary file and digital vernier caliper. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gingival Index (GI) | Baseline (preoperative), 6 weeks, and 12 weeks | Gingival Bleeding Index |
| Plaque Index (PI) | Baseline (preoperative), 6 weeks, and 12 weeks | O'Leary plaque index |
Countries
Iraq
Outcome results
None listed