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.
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.
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
- : 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.
- Conditions
- Dental Implant Failure Nos
- 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 group | Role | What they receive |
|---|---|---|
| group A (Concentrated Growth Factor) CGF | Active comparator | ten 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) PRGF | Active comparator | Ten 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.
Bone Density
evaluation of bone density around immediate implants as (D1,D2,D3,D4)
Measured: 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
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start1 Feb 2022
- Primary completion30 Jul 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dental Implant Failure NosStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hussein Fathy Mohammad Hussein Abo Elkheir, Minia University
- Investigators
- ahmed a khalil, PhD, Study director, oral medicine and periodontology department faculty of dentistry minia universityAhmed a Mustafa, PhD, Study director, oral medicine and periodontology department faculty of dentistry minia universityhussein f mohammad, bachelor, Principal investigator, oral medicine and periodontology department faculty of dentistry minia university
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
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: age medical history oral hygiene status
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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}
- ClinicalTrials.gov ID
- NCT05595772
- Acronym / sponsor ID
- HFMHAElkhe0001
- Conditions
- Dental Implant Failure Nos
- Keywords
- immediate implant, PRGF, CGF, Plasma rich in growth factors, concentrated growth factor, labial dehiscence, platelet concentrate, bio-membrane
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 27 Oct 2022 (actual)
- Results
- Posted 9 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- : 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study will use simple randomization to allocate patients into 2 groups, each group will be included 10 patients.
| Arm | Type | Receives |
|---|---|---|
| group A (Concentrated Growth Factor) CGF | Active comparator | Drug: Drug: Growth Factors (CGF), Procedure: Surgery: Dental Implant surgery, Procedure: Tooth extraction, Procedure: Xenogenic bone graftingten patients indicated for immediate implant in the maxillary anterior region (class II socket) |
| group B (Plasma Rich in Growth Factor) PRGF | Active comparator | Drug: Drug: Growth Factors (PRGF), Procedure: Surgery: Dental Implant surgery, Procedure: Tooth extractionTen patients who indicated immediate implant in the maxillary anterior region (class I or class II socket), |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- Pregnant female.
- Para-functional habits such as bruxism and clenching Patients suffering from periodontitis.
- Smokers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drug: Growth Factors (CGF)Also: Concentrated growth factorApplication of biological membrane of Concentrated growth factor (CGF) over bone grafting and implant | Drug | group A (Concentrated Growth Factor) CGF |
| Drug: Growth Factors (PRGF)Also: Plasma rich in growth factorsApplication of biological membrane of Plasma rich in growth factors combined with Xenogeneic bone grafting material around immediate implant | Drug | group B (Plasma Rich in Growth Factor) PRGF |
| Surgery: Dental Implant surgeryImmediate implant following extraction | Procedure or surgery | group A (Concentrated Growth Factor) CGF, group B (Plasma Rich in Growth Factor) PRGF |
| Tooth extractionA Traumatic tooth extraction | Procedure or surgery | group A (Concentrated Growth Factor) CGF, group B (Plasma Rich in Growth Factor) PRGF |
| Xenogenic bone graftingApplication of bovine bone grafting over area of dehiscence around immediate implant | Procedure or surgery | group A (Concentrated Growth Factor) CGF |
Primary outcome
Bone Density
Time frame: 9 months
evaluation of bone density around immediate implants as (D1,D2,D3,D4)
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. age medical history oral hygiene status
Related trials for Dental Implant Failure Nos
Recruiting
Guided Lateral Sinus Lifting Using Autologous Serum Albumin/Platelet-Rich Fibrin
Sinus Perforation, Dental Implant Failure Nos
Recruiting
Clinical Efficacy of Nobel Parallel CC Implants With on1 Abutment in Posterior Area Participants
Mechanical Failure of Dental Implant Nos
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ahmed a khalil, PhD study director
oral medicine and periodontology department faculty of dentistry minia university
Ahmed a Mustafa, PhD study director
oral medicine and periodontology department faculty of dentistry minia university
hussein f mohammad, bachelor principal investigator
oral medicine and periodontology department faculty of dentistry minia university
1 site in 1 country: see every site and its 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.