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Dental Implant Failure NosNCT05595772

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

A study testing Drug: Growth Factors (CGF), Drug: Growth Factors (PRGF) and Surgery: Dental Implant surgery in people with Dental Implant Failure Nos, run by Minia University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Dental Implant Failure Nos
What is being tested?
Drug: Growth Factors (CGF), Drug: Growth Factors (PRGF) and Surgery: Dental Implant surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteEgypt
Study dates
1 Feb 2022to 30 Aug 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Faculty of Dentistry Minia University

    Minya, 61519

Other trials in Egypt

About this study

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

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.

Read the detailed description

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

  1. : Assess the effectiveness of PRGF and CGF in the management of buccal dehiscence and marginal bone level around the immediate implant.
  2. : 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:

  1. 0.5 mL Plasma poor in growth factors (PPGFs) =F1 in the uppermost part of the tube
  2. 0.5 mL Plasma with growth factors (PGFs) = F2
  3. 0.5 mL (PRGF) = F3 located immediately above the red blood cell portion in the tube
  4. 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

  1. 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
  2. Nerve block or infiltration anesthesia will be administrated Articaine (4%) with epinephrine (1:100,000 or 1:200,000)
  3. 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
  4. A sample of venous blood will be withdrawn from the patient and centrifuged without delay according to the preparation protocol of each group.
  5. 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.
  6. Finally, Tension-free Closure of the wound was achieved using 4/0 vicryl sutures.
Being tested
Drug: Growth Factors (CGF), Drug: Growth Factors (PRGF), Surgery: Dental Implant surgery, Tooth extraction, Xenogenic bone grafting
Keywords
immediate implant, PRGF, CGF, Plasma rich in growth factors, concentrated growth factor, labial dehiscence, platelet concentrate, bio-membrane, xenogenic bone graft

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Drug: Growth Factors (CGF)Drug

    Also called Concentrated growth factor

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

  • Drug: Growth Factors (PRGF)Drug

    Also called Plasma rich in growth factors

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

  • Surgery: Dental Implant surgeryProcedure or surgery

    Immediate implant following extraction

  • Tooth extractionProcedure or surgery

    A Traumatic tooth extraction

  • Xenogenic bone graftingProcedure or surgery

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

Study groups in NCT05595772
Study groupRoleWhat they receive
group A (Concentrated Growth Factor) CGFActive comparatorten patients indicated for immediate implant in the maxillary anterior region (class II socket)
Receives: Drug: Drug: Growth Factors (CGF); Procedure: Surgery: Dental Implant surgery; Procedure: Tooth extraction; Procedure: Xenogenic bone grafting
group B (Plasma Rich in Growth Factor) PRGFActive comparatorTen patients who indicated immediate implant in the maxillary anterior region (class I or class II socket),
Receives: Drug: Drug: Growth Factors (PRGF); Procedure: Surgery: Dental Implant surgery; Procedure: Tooth extraction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bone Density

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

    Measured: 9 months

  2. 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

    Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2022
  2. Study start1 Feb 2022
  3. Primary completion30 Jul 2023
  4. Study completion30 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
The study will use simple randomization to allocate patients into 2 groups, each group will be included 10 patients.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05595772
Sponsor's protocol ID
HFMHAElkhe0001
Status last verified
Jun 2026
First submitted
13 Oct 2022
Last updated
9 Jun 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: age medical history oral hygiene status

Questions about this trial

What is this clinical trial studying?

A study testing Drug: Growth Factors (CGF), Drug: Growth Factors (PRGF) and Surgery: Dental Implant surgery in people with Dental Implant Failure Nos, run by Minia University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bone Density (time frame: 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.

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