Evaluation and Comparison of Postoperative outcome of intra socket placement of Platelet Rich Fibrin with and without Collagen Plug in Extraction Socket of Impacted Mandibular Third Molar.

Phase 3

Not yet recruiting

• Conditions: Impacted teeth,

• Registration Number: CTRI/2025/06/089580
• Lead Sponsor: Datta Meghe Institute of Higher Education and Research

Brief Summary

BackgroundImpacted mandibular third molars are frequently encountered in dental practice, often due to limited space between the second molar and the mandibular ramus. Their removal can lead to complications such as bone loss, pain, swelling, periodontal issues, and delayed healing of adjacent structures.

Platelet Rich Fibrin PRF: An autologous healing aid rich in growth factors that enhance tissue repair through angiogenesis, collagen formation, and cellular activity. However, its preparation requires expensive centrifugation equipment.

Collagen Plug: A bioabsorbable scaffold that enhances tissue healing and bone regeneration. It is easy to use and helps maintain the integrity of the socket post-extraction.

AimTo evaluate and compare the postoperative effects of intra-socket placement of PRF with and without a collagen plug after removal of impacted mandibular third molars.

---

ObjectivesTo evaluate PRF alone in terms of

1. Pain

2. Swelling

3. Soft tissue healing

4. Bone regeneration

To evaluate PRF and Collagen Plug for the same postoperative outcomes. To compare both groups to assess which approach leads to improved healing and regeneration **METHOD** This is a prospective randomized split-mouth clinical study comparing healing outcomes after impacted mandibular third molar extraction using Platelet Rich Fibrin  alone versus Platelet Rich Fibrin combined with a collagen plug. Key parameters assessed include pain, swelling, soft tissue healing, and bone regeneration. The goal is to determine whether the addition of a collagen plug enhances postoperative healing compared to PRF alone.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-06-19
• Study Start: 2025-07-30

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

1.Patients indicated for Surgical Extraction of Impacted bilateral mandibular third molar 2.A medical history devoid of any Pharmacology therapy able to introduce variable into experiments.

Exclusion Criteria

• 1.All patients with uncontrolled systemic diseases.
• 2.Patients who are allergic to materials used during procedure.
• 3.Patients with Diabetes Mellitus, Coronary Artery Disease, Peripheral Vascular Diseases & Cancer.
• 4.Patients on Long term Corticosteroid therapy.
• 5.Patients with immunocompromised status.
• 6.Pregnant and Lactating females 7.Patients with peri apical infections or cyst involving mandibular third molar.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Less post operative pain, Better post operative soft tissue healing and bone regeneration	Assessment will be done on Post operative Day 1, Day 3, Day 7, Day 14 and after 3 months

Secondary Outcome Measures

Name	Time	Method
Reduced Post operative Swelling	Assessment will be done on Post operative Day 1, Day 3, Day 7

Trial Locations

Locations (1)

Sharad Pawar Dental College; 🇮🇳 Wardha, MAHARASHTRA, India

Sharad Pawar Dental College

🇮🇳Wardha, MAHARASHTRA, India

HARSHA SINHA

Principal investigator

7390934540

harshasinha1997@gmail.com