Extraction socket preservation procedure using platelet rich fibrin with and without calcium phosphate cement

Phase 2/3

Completed

Conditions: Systemically healthy patients between the age group 20-45 years having at least two non-molar teeth indicated for extraction.

Registration Number: CTRI/2015/08/006100

Lead Sponsor: Sinhgad Dental College and Hospital

Brief Summary: After extraction, severe hard and softtissue alteration takes place within the affected site of alveolar ridge.1The three dimensional resorption process at extraction sites results innarrower ridges and reduced vertical height and lingual/palatal shifting oftheir long axis. Most of the dimensional alterations take place in the first 3months following tooth removal.2

In the first 12 months after extraction,the height of alveolar ridge can diminish upto 50% because the alveolar boneresorbs especially on the buccal aspect.3 This change may lead to esthetic andfunctional disadvantages that compromise future implant placement particularlyif the dental implant placement needs to be delayed for 6 months or longer.

Hence it is crucial to preserve the dimensions andcontour of the alveolar ridge after tooth extraction to achieve a predictableesthetic and functional prosthetic restoration.

Preservation of the residual alveolarsocket at the time of tooth extraction has been evaluated in many studies. Clinical, histologic and radiographic studiesdocumented positive socket healing responses with autogenous bone, alloplastsand xenografts, whereas others reported poor results with bovine bone,decalcified freeze dried bone & autogenous bone.1, 4, 5, 6, 7, 8

Since they are associated with varyingamounts of vital bone socket fill, comparison studies are useful to determinethe amount of socket preservation that occurs with each material. A new classof alloplast materials, namely, calcium phosphate cements (CPC) raised certainhopes in periodontal repair in the early 1990s. These are aqueous based cements that get converted to hydroxyapatiteupon setting. The combination of biocompatibility,osteoconductivity and restorability makes it a unique material for graftingbony defects.9

Platelet rich fibrin (PRF) is anautologous preparation of concentrated platelets created by centrifugation of apatientâ€™s blood. The use of PRF duringsurgical procedure is a current treatment concept used to accelerate woundhealing and tissue maturation. It can beused directly as a clot or after compression as a strong membrane. 10

Based on these positive findings of calciumphosphate cement and platelet rich fibrin, the purpose of this study is tocompare clinical and radiographic [Cone Beam Computed Tomography (CBCT)]outcomes following grafting for post extraction ridge preservation in sitestreated with platelet rich fibrin with or without calcium phosphate cement.

**Aim:**

To compare the use of platelet richfibrin (PRF) with and without calcium phosphate cement in fresh extractionsockets by clinical and radiographic analyses.

**Objectives:**

1. Toevaluate horizontal and vertical ridge changes associated with PRF used withand without CPC at baseline and after 6 months using clinical and radiographic methods.

2. Tocompare horizontal and vertical ridge changes associated with PRF used with andwithout CPC using clinical and radiographic methods.

3. Toevaluate and compare the radiographic density changes associated with PRF usedwith and without CPC.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 15

Inclusion Criteria

Systemically healthy patients between the age group 20- 45 years Patients having at least two non-molar teeth indicated for extraction.
Indications for extraction include either root fracture, endodontic treatment failure, or non-restorable carious teeth.
Alveolar sockets with 4 wall architecture.
Patients willing to participate and sign an informed consent.

Exclusion Criteria

Patients who are systemically compromised.
Patients having history of smoking or tobacco habit.
Patients on medications that impair hematological parameter.
Patient having history of bone disorder.
Teeth having acute periapical or periodontal pathology.
Pregnant and lactating females.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical and Radiographic of	Time point-at 6 months
a.Marginal bone levels, calculated using a Williams periodontal probe as the distances between the coronal border of the stent and the mid-buccal and the mid-palatal aspect of the alveolar bone crest.	Time point-at 6 months
b.The bucco-palatal width will be measured using a surgical caliper at mid-buccal and mid-palatal aspect of the socket at 1mm, 3mm and 5mm apical to the bone crest.	Time point-at 6 months
Time point-at 6 months	Time point-at 6 months

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (1): Sinhgad Dental College and hospital
🇮🇳
Pune, MAHARASHTRA, India
Sinhgad Dental College and hospital
🇮🇳Pune, MAHARASHTRA, India
Dr Nihal Devkar
Principal investigator
9420481441
drdevkar@gmail.com