Comparison of Two Different Types of Platelet Concentrate to Augment Bone Around Immediate Dental Implant

NCT05595772 | Unknown

• 1 other identifier: HFMHAElkhe0001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinial trial is to detect Which one of two different platelet concentrate bio-membrane (first or third generation) is better in terms of marginal bone level and bone density around immediate implants in esthetic zone using Cone beam computerized tomography The plasma rich in growth factor or concentrated growth factor? 20 patients with nonrestorable maxillary tooth in the esthetic zone, Subjects will be enrolled The study will use simple randomization to allocate patients into 2 groups, each group will be included 10 patients: Group A: (concentrated growth factor group) ten patients indicated for immediate implant in the maxillary anterior region (class II socket), will be a candidate for immediate implant placement with CGF combined with xenogeneic bone graft Group B: (platelet-rich in growth factor group) Ten patients who indicated immediate implant in the maxillary anterior region (class I or class II socket), will be a candidate for immediate implant placement with PRGF combined with xenogeneic bone graft.

Conditions

Dental Implant Failure Nos

Keywords

immediate implant; PRGF; CGF; Plasma rich in growth factors; concentrated growth factor; labial dehiscence; platelet concentrate; bio-membrane; xenogenic bone graft

Outcome Measures

Primary Outcomes (2)

• Bone density

  evaluation of bone density around immediate implants as (D1,D2,D3,D4)

  9 months

• Marginal bone level.

  evaluation of marginal bone level around implant in comparison with baseline bone level immediately after surgery using a fixed point on CBCT

  9 months

Study Arms (2)

group A (Concentrated Growth Factor) CGF

ACTIVE COMPARATOR

ten patients indicated for immediate implant in the maxillary anterior region (class II socket)

Drug: Drug: Growth Factors (CGF); Procedure: Surgery: Dental Implant surgery; Procedure: Tooth extraction; Procedure: Xenogenic bone grafting

group B (Plasma Rich in Growth Factor) PRGF

ACTIVE COMPARATOR

Ten patients who indicated immediate implant in the maxillary anterior region (class I or class II socket),

Drug: Drug: Growth Factors (PRGF); Procedure: Surgery: Dental Implant surgery; Procedure: Tooth extraction

Interventions

Drug: Growth Factors (CGF) DRUG

Application of biological membrane of Concentrated growth factor (CGF) over bone grafting and implant

Also known as: Concentrated growth factor

group A (Concentrated Growth Factor) CGF

Drug: Growth Factors (PRGF) DRUG

Application of biological membrane of Plasma rich in growth factors combined with Xenogeneic bone grafting material around immediate implant

Also known as: Plasma rich in growth factors

group B (Plasma Rich in Growth Factor) PRGF

Surgery: Dental Implant surgery PROCEDURE

Immediate implant following extraction

group A (Concentrated Growth Factor) CGF; group B (Plasma Rich in Growth Factor) PRGF

Tooth extraction PROCEDURE

A Traumatic tooth extraction

group A (Concentrated Growth Factor) CGF; group B (Plasma Rich in Growth Factor) PRGF

Xenogenic bone grafting PROCEDURE

Application of bovine bone grafting over area of dehiscence around immediate implant

group A (Concentrated Growth Factor) CGF

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Selected patients of both sexes are 20-40 years old.
• Patients are systemically healthy based on questionnaire dental modification of Cornell index.
• Gingival health according to the new classification system (2017)
• The recipient site of the implant is free from any pathological conditions.
• Class II extraction socket according to Chang's classification system
• Adequate interocclusal space to accommodate the available restorative components.
• Adequate native/apical bone to achieve primary implant stability.

You may not qualify if:

• Pregnant female.
• Para-functional habits such as bruxism and clenching Patients suffering from periodontitis.
• Smokers.

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Faculty of Dentistry Minia University

Minya, 61519, Egypt

Location

MeSH Terms

Interventions

Intercellular Signaling Peptides and Proteins; Tooth Extraction

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Oral Surgical Procedures; Surgical Procedures, Operative; Dentistry

Study Officials

• ahmed a khalil, PhD

  oral medicine and periodontology department faculty of dentistry minia university

  STUDY DIRECTOR

• Ahmed a Mustafa, PhD

  oral medicine and periodontology department faculty of dentistry minia university

  STUDY DIRECTOR

• hussein f mohammad, bachelor

  oral medicine and periodontology department faculty of dentistry minia university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The study will use simple randomization to allocate patients into 2 groups, each group will be included 10 patients.

Study Record Dates

• First Submitted: October 13, 2022
• First Posted: October 27, 2022
• Study Start: February 1, 2022
• Primary Completion: July 30, 2023
• Study Completion: August 30, 2023
• Last Updated: February 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: after study completion and for 3 years
• Access Criteria: investigators related to official organization

Locations

EG (1)