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

NCT04029779 | Completed Phase 2

• 1 other identifier: 02_D012_81520
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Density; Bone Loss, Alveolar

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Crestal bone level

  Measured 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.

  6 months

• Bone density

  measured 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.

  6 months

Secondary Outcomes (3)

• Angular bleeding index

  6 months

• Peri-implant Probing pocket depth

  6 months

• Pink esthetic score

  6 months

Study Arms (2)

Immediate implant placement coated with I-PRF

EXPERIMENTAL

The test group received implants coated with injectable platelet-rich fibrin and also the sockets were injected with injectable- platelet rich fibrin

Biological: I-PRF

immediate implant only

NO INTERVENTION

The control group received immediate dental implants only after extraction of the teeth without any local coating.

Interventions

I-PRF BIOLOGICAL

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.

Also known as: injectable platelet rich fibrin coated to dental implants.

Immediate implant placement coated with I-PRF

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. 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

You may not qualify if:

• Persistent \& unresolved infection at implant site
• Teeth with close proximity to anatomical structure and adjacent roots
• Patients on radiotherapy
• Patients with systemic disorders
• Patients with parafunctional habits
• Patients with history of alcohol, drug dependency and smoking

Sponsors & Collaborators

• Krishnadevaraya College of Dental Sciences & Hospital: lead

Study Sites (1)

Krishnadevaraya college of dental sciences

Bangalore, Karnataka, 562157, India

Location

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 19, 2019
• First Posted: July 23, 2019
• Study Start: November 11, 2017
• Primary Completion: November 30, 2019
• Study Completion: November 30, 2019
• Last Updated: December 12, 2019

Record last verified: 2019-12

Locations

IN (1)