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Evaluation of Immediately Placed Dental Implants With Local Application of Injectable PRF in Periodontally Compromised Sites

Evaluation of Immediately Placed Dental Implants With Local Application of Injectable-Platelet Rich Fibrin in Periodontally Compromised Sites. A Randomized Controlled Split Mouth Study

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04029779
Acronym
PRF
Enrollment
10
Registered
2019-07-23
Start date
2017-11-11
Completion date
2019-11-30
Last updated
2019-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Density, Bone Loss, Alveolar

Keywords

Injectable platelet rich fibrin, Bone density, Crestal bone loss, Immediate implants

Brief summary

The present study is a human, prospective, parallel, randomised controlled clinical trial conducted to explore the efficacy of injectable PRF around dental implants. The trial is in accordance with the Consolidated Standards of Reporting Trials (CONSORT) criteria, 2010.

Detailed description

Ten healthy individuals satisfying the inclusion and exclusion criteria were recruited for the study. A detailed, thorough medical and dental history was obtained and each patient was subjected to comprehensive clinical and radiological examination. All patients were informed about the nature of the study, the surgical procedure involved, potential benefits and risks associated with the surgical procedure and written informed consent were obtained from all patients. All the patients were treated with immediate implants. The injectable -PRF was coated on implants as well as injected in the socket in both the maxillary and mandibular anterior region. The clinical and radiographic parameters were recorded at baseline, three months and six months postoperatively.

Interventions

BIOLOGICALI-PRF

Local anaesthesia was administered and mucoperiosteal flap was reflected. Atraumatic tooth extraction was performed. Socket was curetted to remove the granulation tissue present in the socket with the help of curettes. The socket was well irrigated with saline. Implant osteotomies wasl performed with sequential drilling with standardized drills.I-PRF was freshly prepared 600rpm for 7 min(50g). 1ml of the i-PRF was applied in to the osteotomy site and the implant surface will be thoroughly coated followed by placing of the implant. The surgical site was thoroughly irrigated and debrided. Flap closure was achieved using 3-0 silk sutures to protect the implant site.

Sponsors

Krishnadevaraya College of Dental Sciences & Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Two groups were made one test and control. All the subjects were treated with immediate implants. In the test group subjects, injectable platelet-rich fibrin was coated around dental implants and was also injected in the socket. The control group received only dental implants.

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

1\. Cooperative patients willing to participate in the study 2. At least two maxillary or mandibular anterior teeth indicated for extraction due to chronic periodontitis (chronic or aggressive) 3. Patients above 18 years of age 4. Patients with esthetic concerns 5. Patients with good oral hygiene maintenance 6. Adequate bone height apical to alveolus of the failing teeth (more than or equal to 5mm) to accommodate an implant \-

Exclusion criteria

1. Persistent & unresolved infection at implant site 2. Teeth with close proximity to anatomical structure and adjacent roots 3. Patients on radiotherapy 4. Patients with systemic disorders 5. Patients with parafunctional habits 6. Patients with history of alcohol, drug dependency and smoking

Design outcomes

Primary

MeasureTime frameDescription
Crestal bone level6 monthsMeasured using CBCT scan both on mesial and distal sides .The coronal surface of the implant will be taken as reference line from where two perpendicular lines are dropped on both mesial and distal aspect of implants to first bone to implant contact.
Bone density6 monthsmeasured using CBCT scan using Hounsfield units at mid point of the implant both on mesial and distal side with coronal portion of implant as reference line.

Secondary

MeasureTime frameDescription
Angular bleeding index6 monthsA periodontal probe passed along the buccal margin at 60 degrees angulation in gingival sulcus. The resultant bleeding is recorded as present (+) or absent (-).
Peri-implant Probing pocket depth6 monthsmeasured mesially and distally using a UNC-15 probe (university of North Carolina-15 periodontal probe- Hu-Friedy, Chicago, IL, USA).
Pink esthetic score6 monthsDigital photographs will be used for evaluation of the pink esthetic score(PES). Charts containing the seven variables will be designed. These include: mesial papilla, distal papilla, soft tissue level, soft tissue contour, alveolar process deficiency, soft tissue colour and texture. Each variable will be recorded with a 2-1-0 score, where 2 is the best and 0 is the poorest score.

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026