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

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

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.

Study Overview

• Status: Completed
• Conditions: Bone Density; Bone Loss, Alveolar
• Intervention / Treatment: Biological: I-PRF

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2

Contacts and Locations

Study Locations

• India
  • Karnataka
    • Bangalore, Karnataka, India, 562157
      • Krishnadevaraya college of dental sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate implant placement coated with I-PRF; 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; 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.; Other Names: injectable platelet rich fibrin coated to dental implants.
No Intervention: immediate implant only; The control group received immediate dental implants only after extraction of the teeth without any local coating.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Angular bleeding index	A periodontal probe passed along the buccal margin at 60 degrees angulation in gingival sulcus. The resultant bleeding is recorded as present (+) or absent (-).	6 months
Peri-implant Probing pocket depth	measured mesially and distally using a UNC-15 probe (university of North Carolina-15 periodontal probe- Hu-Friedy, Chicago, IL, USA).	6 months
Pink esthetic score	Digital 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.	6 months

Collaborators and Investigators

• Sponsor: Krishnadevaraya College of Dental Sciences & Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2017
• Primary Completion (Actual): November 30, 2019
• Study Completion (Actual): November 30, 2019

Study Registration Dates

• First Submitted: July 19, 2019
• First Submitted That Met QC Criteria: July 22, 2019
• First Posted (Actual): July 23, 2019

Study Record Updates

• Last Update Posted (Actual): December 12, 2019
• Last Update Submitted That Met QC Criteria: December 11, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Immediate implants; Bone density; Injectable platelet rich fibrin; Crestal bone loss
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Bone Diseases; Periodontal Atrophy; Bone Resorption; Alveolar Bone Loss
• Other Study ID Numbers: 02_D012_81520

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No