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Clinical Trials/NCT06525324
NCT06525324
Not yet recruiting
Not Applicable

Comparing The Effectiveness Of T-PRF And PRF With Bone-Graft[DMBM]TM Around Immediate Implants - A RANDOMISED CONTROL TRIAL

Krishnadevaraya College of Dental Sciences & Hospital1 site in 1 country20 target enrollmentAugust 2024
ConditionsDental Implants

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dental Implants
Sponsor
Krishnadevaraya College of Dental Sciences & Hospital
Enrollment
20
Locations
1
Primary Endpoint
Marginal Bone Level Using RVG and Grid.
Status
Not yet recruiting
Last Updated
last year

Overview

Brief Summary

The normal architecture of the alveolar process is altered by periodontitis, which also causes the loss of alveolar bone surrounding the teeth. Untreated periodontitis may cause teeth to become mobile and leads to loss of teeth.

In such cases, one of the treatment modalities is extraction of the tooth and placement of immediate implant which reduces the waiting period. And due to the resorption of alveolar ridge the bone graft will be used along with T-PRF and PRF.

So this study aims at the placement of immediate implants along with T-PRF with bone graft and PRF with bone graft.

Detailed Description

Dental implants have become more common treatment for replacing missing teeth and aim to improve chewing efficiency, physical health and esthetic. And their will be resorption of alveolar process due to periodontitis . In such compromised cases, to achieve bone augmentation around immediately placed implants a new modality of using platelet rich fibrin (PRF) along with graft material has gained considerable interest. Successful clinical results have been reported with L-PRF, but some physicians worry about a possible health hazard with glass-evacuated blood collection tubes with silica activators. O'Connell described the unavoidable silica contact. The silica particles in the tube, although dense enough to sediment with the red blood cells, are small enough for a fraction to remain colloidally suspended in the buffy coat, fibrin, and platelet-poor plasma layers therefore, these particles might reach the patient when the product is used for treatment. Recently use of titanium tubes in the preparation of PRF showed more polymerized fibrin formation with longer resorption in tissues as titanium seems to be more effective in activating platelets than silica and also eliminates the possible silica contamination. The use of T-PRF(Titanium PRF) along with xenograft creates a block graft with high concentrated growth factors, platelets and leucocytes which enhance development of bone and eliminates the possible silica contamination. Hence, the aim of the study is to compare the effectiveness of T-PRF with xenograft \[DMBM\] and PRF with xenograft \[DMBM\] around immediate implants.

Registry
clinicaltrials.gov
Start Date
August 2024
End Date
October 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Krishnadevaraya College of Dental Sciences & Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients between 18-55 years of age.
  • Presence of non-restorable teeth (maxillary or mandibular) due to trauma, decayed, mobility, root resorption, root stumps, root fracture, over retained deciduous tooth, endodontic or periodontal failure in whom immediate implants can be placed.
  • Good oral hygiene.
  • Good patient compliance.
  • Class I extraction socket defects according to modified Elian et al 2021.

Exclusion Criteria

  • Systemic complications (uncontrolled diabetes and severe cardiovascular or infectious diseases).
  • Intravenous and oral bisphosphonate therapy.
  • Patients who are psychologically unable to participate.
  • Pregnant and lactating participants with bone diseases
  • Patients on chemotherapy or radiotherapy
  • Alcohol or drug abuse.

Outcomes

Primary Outcomes

Marginal Bone Level Using RVG and Grid.

Time Frame: Baseline , 3 months , 9 months

Marginal bone level measured .

Bone dimensions using CBCT

Time Frame: 9 months

Extent of bone dimensions is measured through CBCT

Bone fill using RVG with grid

Time Frame: 3 months , 9 months

Measuring the Bone fill by formula Linear bone growth/depth of original bone defect

Soft tissue healing

Time Frame: Baseline ,3 months , 9 months

Soft tissue healing will be assessed using Wachtel-et-al 2009 classification

Study Sites (1)

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