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Completed

NCT Number: NCT05595772

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

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.

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Key information

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry Minia University

Minya, 61519, Egypt

About this study

with the increasing practice of dental implants; the esthetic outcome is considered as important as the functional and biological outcome Immediate implants have been evolved as the first treatment option in cases of the failed tooth to decrease the time of treatment plan To obtain an effective esthetic outcome with a single implant-supported restoration in the anterior region, it is crucial to preserve and maintain intact the bone anatomy

Numerous studies have explored the suitability of biocompatible materials in regenerative medicine. Platelet concentrates are originated from centrifuged blood and are named according to their biological characteristics, such as platelet-rich plasma, platelet-rich fibrin, and concentrated growth factor

Plasma rich in growth factors (PRGF), a subtype of P-PRP (pure platelet-rich plasma), is a supernatant enriched in plasma and platelet-derived morphogens, proteins, and growth factors. PRGF represents a complex pool of active mediators that may stimulate and accelerate tissue regeneration, which is generally safe to use and economical to obtain. Autologous PRGF has been approved for clinical use by the European Community and the U.S. Food and Drug Administration

CGF (concentrated growth factor), the third-generation platelet concentrate presented by Sacco in 2006 carries more growth factors and has a firmer fibrin structure than first-generation PRP and second-generation PRF (platelet-rich fibrin)

Aim of the study is

  • : Assess the effectiveness of PRGF and CGF in the management of buccal dehiscence and marginal bone level around the immediate implant.
  • : Compare the effectiveness of PRGF Vs CGF.

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.

Protocol for CGF preparation:

10 ml venous blood samples will be drawn from the patients and placed in a centrifuge tube without anticoagulants. Then the tubes will be placed in the centrifugation device in an opposing balanced manner and rotated in four sequential steps. The first step at 735 g (2249 ≈ 2200) for 2 min., the second one at 580 g (1998 ≈ 2000) for 4 min., the third one at 735 g (2249 ≈ 2200) for 4 min. and the fourth one at 905 g (2495 ≈ 2500) for 3 min. The result was a clot that was collected using a straight tweezer and ready to be used

Protocol for PRGF preparation:

30 ml venous blood will be collected from the patient then deposited in 5 mL tubes containing sodium citrate anticoagulant. Then the tubes will be centrifuged at 580 G (2270 rpm) for 8 minutes at room temperature. After centrifugation, the blood sample will be layered into the following four distinctive layers:

  • 0.5 mL Plasma poor in growth factors (PPGFs) =F1 in the uppermost part of the tube
  • 0.5 mL Plasma with growth factors (PGFs) = F2
  • 0.5 mL (PRGF) = F3 located immediately above the red blood cell portion in the tube
  • Red blood cell concentrate layer From all tubes, The 500 μL PPGF will be eliminated and the PRGF will be separated with 500 μL pipettes and transported to an independent dish then activated using 50 μL of 10% calcium chloride for every 1 ml of preparation and mixed with xenogenic bone graft then it will be incubated for 40 minutes in 37̊c to produce easy to handle gelatinous layer (PRGF) fibrin mixed with the xenogenic bone.

Surgical Phase

  • The surgical site will be prepared by scrubbing the surgical site using Betadine: Povidone-iodine, 7.5% (0.75% available iodine) the Nile Comp. for Pharmaceuticals and Chemical Industries, Alexandria, Egypt
  • Nerve block or infiltration anesthesia will be administrated Articaine (4%) with epinephrine (1:100,000 or 1:200,000)
  • Atraumatic extraction of the tooth or remaining root using periotome, then sequential implant drilling accompanied by copious irrigation will be carried out. then cover screw attached to the implant top by the aid of its driver
  • A sample of venous blood will be withdrawn from the patient and centrifuged without delay according to the preparation protocol of each group.
  • Then the membrane loaded with the bone graft will be applied and condensed around the dental implant filling the gap between the fixture and the walls of the socket.
  • Finally, Tension-free Closure of the wound was achieved using 4/0 vicryl sutures.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Drug: Growth Factors (CGF)

Drug

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

Other names: Concentrated growth factor

Drug: Growth Factors (PRGF)

Drug

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

Other names: Plasma rich in growth factors

Surgery: Dental Implant surgery

Procedure

Immediate implant following extraction

Tooth extraction

Procedure

A Traumatic tooth extraction

Xenogenic bone grafting

Procedure

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

Primary outcomes

  1. Bone Density

    Time frame: 9 months

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

  2. Marginal Bone Level.

    Time frame: 9 months

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

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study title

PRGF VS CGF in Management of Labial Dehiscence Around Immediate Implants (Comparative Study) {PRGF= Plasma Rich in Growth Factors } {CGF=Concentrated Growth Factor}

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 27, 2022
Registry last updated
Jun 9, 2026

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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