## Protocol Section
### Identification Module
**NCT ID:** NCT04029779

**Acronym:** PRF

**Brief Title:** 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

#### Organization Study ID Info
**ID:** 02_D012_81520
#### Organization
**Class:** OTHER
**Full Name:** Krishnadevaraya College of Dental Sciences & Hospital
### Status Module
#### Completion Date
**Date:** 2019-11-30

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-12-12

**Type:** ACTUAL

**Last Update Submit Date:** 2019-12-11

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2019-11-30

**Type:** ACTUAL

#### Start Date
**Date:** 2017-11-11

**Type:** ACTUAL

**Status Verified Date:** 2019-12

#### Study First Post Date
**Date:** 2019-07-23
**Type:** ACTUAL
**Study First Submit Date:** 2019-07-19
**Study First Submit QC Date:** 2019-07-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Krishnadevaraya College of Dental Sciences & Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Bone Density

- Bone Loss, Alveolar

**Keywords:**

- Injectable platelet rich fibrin

- Bone density

- Crestal bone loss

- Immediate implants

### Design Module

#### Design Info

**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.

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 10

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Biological: I-PRF

**Label:** Immediate implant placement coated with I-PRF

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Label:** immediate implant only

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Immediate implant placement coated with I-PRF

**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.

**Name:** I-PRF

**Other Names:**

- injectable platelet rich fibrin coated to dental implants.

**Type:** BIOLOGICAL

### Outcomes Module

#### Primary Outcomes

**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.

**Measure:** Crestal bone level

**Time Frame:** 6 months

**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.

**Measure:** Bone density

**Time Frame:** 6 months

#### Secondary Outcomes

**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 (-).

**Measure:** Angular bleeding index

**Time Frame:** 6 months

**Description:** measured mesially and distally using a UNC-15 probe (university of North Carolina-15 periodontal probe- Hu-Friedy, Chicago, IL, USA).

**Measure:** Peri-implant Probing pocket depth

**Time Frame:** 6 months

**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.

**Measure:** Pink esthetic score

**Time Frame:** 6 months

### Eligibility Module

**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:

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

**Healthy Volunteers:** True

**Maximum Age:** 55 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Bangalore

**Country:** India

**Facility:** Krishnadevaraya college of dental sciences

**State:** Karnataka

**Zip:** 562157

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001862

- Term: Bone Resorption

- ID: D000001847

- Term: Bone Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000055093

- Term: Periodontal Atrophy

- ID: D000010510

- Term: Periodontal Diseases

- ID: D000009059

- Term: Mouth Diseases

- ID: D000009057

- Term: Stomatognathic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: BC07

- Name: Mouth and Tooth Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M18747

- Name: Alveolar Bone Loss

- Relevance: HIGH

- As Found: Bone Loss, Alveolar

- ID: M5141

- Name: Bone Resorption

- Relevance: LOW

- As Found: Unknown

- ID: M5126

- Name: Bone Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4589

- Name: Atrophy

- Relevance: LOW

- As Found: Unknown

- ID: M28025

- Name: Periodontal Atrophy

- Relevance: LOW

- As Found: Unknown

- ID: M13419

- Name: Periodontal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12019

- Name: Mouth Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12017

- Name: Stomatognathic Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000016301

- Term: Alveolar Bone Loss

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
