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

NCT06525324 | Not Yet Recruiting

• 1 other identifier: 02_D012_00041
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Implants

Keywords

PRF with bone graft; T-PRF with bone graft

Outcome Measures

Primary Outcomes (4)

• Marginal Bone Level Using RVG and Grid.

  Marginal bone level measured .

  Baseline , 3 months , 9 months

• Soft tissue healing

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

  Baseline ,3 months , 9 months

• Bone fill using RVG with grid

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

  3 months , 9 months

• Bone dimensions using CBCT

  Extent of bone dimensions is measured through CBCT

  9 months

Study Arms (2)

in 10 sites immediate implant will be placed along with T-PRF and xenograft

EXPERIMENTAL

Immediate implant is placed along with T-PRF and xenograft.

Procedure: Immediate implant surgery with T-PRF and xenograft

in 10 sites immediate implants will be placed with PRF and xenograft

ACTIVE COMPARATOR

Immediate implant is placed along with PRF and xenograft as control

Procedure: Immediate implant surgery with PRF and xenograft

Interventions

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

in 10 sites immediate implant will be placed along with T-PRF and xenograft

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

in 10 sites immediate implants will be placed with PRF and xenograft

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Krishnadevaraya College of Dental Sciences & Hospital: lead

Study Sites (1)

Krishnadevaraya college of dental sciences

Bangalore, Karnataka, 562157, India

Location

Related Publications (1)

• Tunali M, Ozdemir H, Kucukodaci Z, Akman S, Firatli E. In vivo evaluation of titanium-prepared platelet-rich fibrin (T-PRF): a new platelet concentrate. Br J Oral Maxillofac Surg. 2013 Jul;51(5):438-43. doi: 10.1016/j.bjoms.2012.08.003. Epub 2012 Aug 28.

  PMID: 22951383 BACKGROUND

MeSH Terms

Interventions

Transplantation, Heterologous; Prolactin-Releasing Hormone

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2024
• First Posted: July 29, 2024
• Study Start: August 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: October 1, 2025
• Last Updated: July 29, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)