Back to resultsEvaluation of Immediately Placed Dental Implants With Local Application of Injectable PRF in Periodontally Compromised Sites (PRF)
Primary Purpose
Bone Density, Bone Loss, Alveolar
Status
Completed
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
I-PRF
Sponsored by
About this trial
This is an interventional prevention trial for Bone Density focused on measuring Injectable platelet rich fibrin, Bone density, Crestal bone loss, Immediate implants
Eligibility Criteria
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:
- 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
Sites / Locations
- Krishnadevaraya college of dental sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Immediate implant placement coated with I-PRF
immediate implant only
Arm Description
The test group received implants coated with injectable platelet-rich fibrin and also the sockets were injected with injectable- platelet rich fibrin
The control group received immediate dental implants only after extraction of the teeth without any local coating.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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 (-).
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).
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.
Full Information
NCT ID
NCT04029779
First Posted
July 19, 2019
Last Updated
December 11, 2019
Sponsor
Krishnadevaraya College of Dental Sciences & Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04029779
Brief Title
Evaluation of Immediately Placed Dental Implants With Local Application of Injectable PRF in Periodontally Compromised Sites
Acronym
PRF
Official Title
Evaluation of Immediately Placed Dental Implants With Local Application of Injectable-Platelet Rich Fibrin in Periodontally Compromised Sites. A Randomized Controlled Split Mouth Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
November 11, 2017 (Actual)
Primary Completion Date
November 30, 2019 (Actual)
Study Completion Date
November 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Krishnadevaraya College of Dental Sciences & Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Density, Bone Loss, Alveolar
Keywords
Injectable platelet rich fibrin, Bone density, Crestal bone loss, Immediate implants
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Immediate implant placement coated with I-PRF
Arm Type
Experimental
Arm Description
The test group received implants coated with injectable platelet-rich fibrin and also the sockets were injected with injectable- platelet rich fibrin
Arm Title
immediate implant only
Arm Type
No Intervention
Arm Description
The control group received immediate dental implants only after extraction of the teeth without any local coating.
Intervention Type
Biological
Intervention Name(s)
I-PRF
Other Intervention Name(s)
injectable platelet rich fibrin coated to dental implants.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Crestal bone level
Description
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.
Time Frame
6 months
Title
Bone density
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Angular bleeding index
Description
A periodontal probe passed along the buccal margin at 60 degrees angulation in gingival sulcus. The resultant bleeding is recorded as present (+) or absent (-).
Time Frame
6 months
Title
Peri-implant Probing pocket depth
Description
measured mesially and distally using a UNC-15 probe (university of North Carolina-15 periodontal probe- Hu-Friedy, Chicago, IL, USA).
Time Frame
6 months
Title
Pink esthetic score
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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:
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
Facility Information:
Facility Name
Krishnadevaraya college of dental sciences
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
562157
Country
India
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Immediately Placed Dental Implants With Local Application of Injectable PRF in Periodontally Compromised Sites
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