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NCT Number: NCT06525324

Comparision of Clinical Efficacy of Immediate Implants With T-PRF and Bone-graft Versus PRF and Bone-graft

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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Krishnadevaraya college of dental sciences

Bangalore, Karnataka, 562157, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Immediate implant surgery with T-PRF and xenograft

Procedure

A mucoperiosteal flap will be raised and atraumatic extraction will be done. An immediate implant with T-PRF and xenograft will be placed according to the standard protocol.

The surgical wound closure will be coapted with mattress and single interrupted sutures

Immediate implant surgery with PRF and xenograft

Procedure

A mucoperiosteal flap will be raised and atraumatic extraction will be done. An immediate implant with PRF and xenograft will be placed according to the standard protocol .

The surgical wound closure will be coapted with mattress and single interrupted sutures

Primary outcomes

  1. Marginal Bone Level Using RVG and Grid.

    Time frame: Baseline , 3 months , 9 months

    Marginal bone level measured .

  2. Soft tissue healing

    Time frame: Baseline ,3 months , 9 months

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

  3. 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

  4. Bone dimensions using CBCT

    Time frame: 9 months

    Extent of bone dimensions is measured through CBCT

Sponsors and collaborators

Lead sponsor

Krishnadevaraya College of Dental Sciences & Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 29, 2024
Registry last updated
Jul 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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