Clinical trial NCT04029779: Evaluation of Immediately Placed Dental Implants With Local Application of Injectable PRF in Periodontally Compromised Sites
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bone Density
Bone Loss, Alveolar
Keywords: Injectable platelet rich fibrin
Bone density
Crestal bone loss
Immediate implants
Lead sponsor: Krishnadevaraya College of Dental Sciences & Hospital
Sponsor class: OTHER
First posted: 2019-07-23
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

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

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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

Primary outcomes:
measure: Crestal bone level
timeFrame: 6 months
measure: Bone density
timeFrame: 6 months
Secondary outcomes:
measure: Angular bleeding index
timeFrame: 6 months
measure: Peri-implant Probing pocket depth
timeFrame: 6 months
measure: Pink esthetic score
timeFrame: 6 months
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Krishnadevaraya college of dental sciences
state: Karnataka
Study officials:
References: