Periodontal DiseasesPhase 2NCT06162832
Periodontal Regeneration With Recombinant Human Platelet Derived Growth Factor (rH-PDGF-BB) and Allograft
A Phase 2 study testing Allograft and rHPDGF-BB and Allograft and Saline solution in people with Periodontal Diseases, run by Universidad Autonoma de Nuevo Leon at 1 site in Mexico.
Trial summary
Growth factors are defined as small proteins that trigger a cellular response after binding to cell receptors; Tissue engineering is now clinically applicable in a commercially available system involving the use of recombinant human platelet-derived growth factor. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- Allograft and rHPDGF-BB and Allograft and Saline solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteMexico
- Study dates
- 10 Jan 2024to 15 Jan 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of periodontitis
- Infrabony defects of 2 walls, 3 walls and combined defects
- Patients ASA (American Society of Anesthesiologists) I and II
- Patients who smoke less than 10 cigarettes
Who cannot join
- Patients undergoing bisphosphonate therapy
- Furcation defects
- Patients with evidence of blood dyscrasias.
- Pregnant patient
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Posgrado de Periodoncia, Facultad de Odontología, Universidad Autónoma de Nuevo León
Monterrey, Nuevo León, 64460
Jesus I Rodriguez Pulido, Dr, 52 81 83294000 ext. 3192, jesus.rodriguezpl@uanl.edu.mx
About this study
Official title: Evaluation of Clinical and Radiographic Parameters in Bony Defects Treated With Recombinant Human Platelet-derived Growth Factor in Combination With Allograft
Growth factors are defined as small proteins that trigger a cellular response after binding to cell receptors; Tissue engineering is now clinically applicable in a commercially available system involving the use of recombinant human platelet-derived growth factor.
The objective of this study is to evaluate clinical and radiographic parameters in bone defects treated with platelet-derived growth factor in combination with allograft.
Our hypothesis: Defects treated with DFDBA and rhPDGF-BB have better clinically and radiographic results that the defects treated with DFDBA and saline solution.
Read the detailed description
The study will be performed in 30 periodontal defects of 2 and 3 walls. The experimental group will consist of DFDBA placement with rhPDGF-BB and control DFDBA with saline solution. The clinical parameters recorded were Probing deep (PD), clinical attachment level (CAL), recession depth, Index of bleeding and plaque at baseline and at six months. Our universe is patients with periodontitis attending at the clinical in Periodontics at the Autonomous University of Nuevo Leon (UANL) School of Dentistry.
- Conditions
- Periodontal Diseases
- Being tested
- Allograft and rHPDGF-BB, Allograft and Saline solution
- Keywords
- Periodontal Regeneration, Grow Factors, intraosseous defects
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allograft and rHPDGF-BBCombination product
Also called GEM21, Allograft
At this intervention the periodontal defect will be treated with allograft and rHPDGF-BB (GEM21)
Allograft and Saline solutionCombination product
This will be used as the control group
| Study group | Role | What they receive |
|---|---|---|
| Allograft | Active comparator | Will be used Demineralized cancellous allograft 250-1000um Receives: Combination Product: Allograft and rHPDGF-BB; Combination Product: Allograft and Saline solution |
| Saline Solution | Sham comparator | The saline solution will be used for hydrate the bone graft 20 minutes before the placement at the defect Receives: Combination Product: Allograft and Saline solution |
| rhPDGF-BB (GEM21, Lynch Biologics) | Experimental | The rhPDGF-BB will be used for hydrate the bone graft 20 minutes before the placement at the defect Receives: Combination Product: Allograft and rHPDGF-BB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing depth
The distance from free gingival margin to sulcus depth, ≥4 millimeters (mm)
Measured: Initial and six months after surgery
Bleeding on probing
Method to asses gingival inflammation. Gingival health is defined as < 10% bleeding sites
Measured: Initial and six months after surgery
Gingival Recession
The distance from the soft tissue (gingiva or alveolar mucosa) margin to cemento-enamel junction, ≥1 millimeters (mm)
Measured: Initial and six months after surgery
Clinical Attachment Level
The distance from the cemento-enamel junction to the tip of a periodontal probe during periodontal diagnostic probing, ≥2 mm (millimeters)
Measured: Initial and six months after surgery
Gingival Phenotype
Gingival phenotype is determined by gingival thickness and keratinized tissue width.
Probe visible: thin (≤1 mm). Probe not visible: thick (>1mm).
Measured: Initial and six months after surgery
Plaque control record
O'Leary index is used for assessing oral hygiene skills of the patient
Measured: Initial and six months after surgery
Radiographic Measurements
Cemento-enamel junction (CEJ)-Defect Base (DB): The distance of the cementoenamel junction at the base of the defect.
Cemento-enamel junction (CEJ)-Bone crest (BC): The distance of the cemento-enamel junction to the crest of bone.
Cemento-enamel junction (CEJ)- Root apex (RA): The distance of the cemento-enamel junction to root apex.
Lineal Bone Growth (LBG) = CEJ to base of defect at baseline - CEJ to base of defect at 6 months.
%BF: Percent bone fill was calculated by dividing LBG by the depth of the original bone defect
Measured: Initial and six months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start10 Jan 2024
- Primary completion16 Jul 2024 (estimated)
- Study completion15 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study was conducted in two groups with control and experimental groups which were evaluated during a period of six months with monthly evaluation until the results were obtained.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Nuevo Leon
- Sponsor type
- University, hospital or other
- Collaborators
- LifeNet Health, Lynch Biologics LLC
- Responsible party
- Principal investigator, Jesus Israel Rodríguez Pulido, Universidad Autonoma de Nuevo Leon
- Investigators
- Jessica P Arredondo Muñoz, Resident, Principal investigator, Posgrado De Periodoncia, Universidad autónoma de Nuevo LeónMaria Fernanda Treviño Campa, Resident, Principal investigator, Posgrado De Periodoncia, Universidad autónoma de Nuevo LeónGloria Martínez Sandoval, DR, Study director, Posgrado De Periodoncia, Universidad autónoma de Nuevo LeónNorma I Rodríguez Franco, DR, Study director, Posgrado De Periodoncia, Universidad autónoma de Nuevo LeónJesús I Rodríguez Pulido, DR, Principal investigator, Posgrado De Periodoncia, Universidad autónoma de Nuevo LeónAndrea Ravidà, DDS, MS, Study chair, Department of Periodontics and Preventive Dentistry, University of Pittsburgh School of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06162832
- Sponsor's protocol ID
- SPSI-010613
- Status last verified
- Apr 2024
- First submitted
- 22 Jun 2023
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McClain PK. The use of recombinant human platelet-derived growth factor-BB in combination with beta-tricalcium phosphate and rhPDGF-BB in combination with freeze-dried bone allograft plus barrier in two separate complex infrabony defects with long-term follow-up. Clin Adv Periodontics. 2022 Dec;12(4):256-261. doi: 10.1002/cap.10212. Epub 2022 Oct 25.
PubMed 36281628Nevins M, Camelo M, Nevins ML, Schenk RK, Lynch SE. Periodontal regeneration in humans using recombinant human platelet-derived growth factor-BB (rhPDGF-BB) and allogenic bone. J Periodontol. 2003 Sep;74(9):1282-92. doi: 10.1902/jop.2003.74.9.1282.
PubMed 14584860Nevins M, Giannobile WV, McGuire MK, Kao RT, Mellonig JT, Hinrichs JE, McAllister BS, Murphy KS, McClain PK, Nevins ML, Paquette DW, Han TJ, Reddy MS, Lavin PT, Genco RJ, Lynch SE. Platelet-derived growth factor stimulates bone fill and rate of attachment level gain: results of a large multicenter randomized controlled trial. J Periodontol. 2005 Dec;76(12):2205-15. doi: 10.1902/jop.2005.76.12.2205.
PubMed 16332231Nevins M, Kao RT, McGuire MK, McClain PK, Hinrichs JE, McAllister BS, Reddy MS, Nevins ML, Genco RJ, Lynch SE, Giannobile WV. Platelet-derived growth factor promotes periodontal regeneration in localized osseous defects: 36-month extension results from a randomized, controlled, double-masked clinical trial. J Periodontol. 2013 Apr;84(4):456-64. doi: 10.1902/jop.2012.120141. Epub 2012 May 21.
PubMed 22612364
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical and Radiographic Parameters in Bony Defects Treated With Recombinant Human Platelet-derived Growth Factor in Combination With Allograft
- ClinicalTrials.gov ID
- NCT06162832
- Acronym / sponsor ID
- SPSI-010613
- Conditions
- Periodontal Diseases
- Keywords
- Periodontal Regeneration, Grow Factors, intraosseous defects
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidad Autonoma de Nuevo LeonUniversity, hospital or other
- Collaborators
- LifeNet Health, Lynch Biologics LLC
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 16 Jul 2024 (estimated)
- Study completion
- 15 Jan 2025 (estimated)
- First posted
- 8 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Growth factors are defined as small proteins that trigger a cellular response after binding to cell receptors; Tissue engineering is now clinically applicable in a commercially available system involving the use of recombinant human platelet-derived growth factor.
The objective of this study is to evaluate clinical and radiographic parameters in bone defects treated with platelet-derived growth factor in combination with allograft.
Our hypothesis: Defects treated with DFDBA and rhPDGF-BB have better clinically and radiographic results that the defects treated with DFDBA and saline solution.
Detailed description
The study will be performed in 30 periodontal defects of 2 and 3 walls. The experimental group will consist of DFDBA placement with rhPDGF-BB and control DFDBA with saline solution. The clinical parameters recorded were Probing deep (PD), clinical attachment level (CAL), recession depth, Index of bleeding and plaque at baseline and at six months. Our universe is patients with periodontitis attending at the clinical in Periodontics at the Autonomous University of Nuevo Leon (UANL) School of Dentistry.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- The study was conducted in two groups with control and experimental groups which were evaluated during a period of six months with monthly evaluation until the results were obtained.
| Arm | Type | Receives |
|---|---|---|
| Allograft | Active comparator | Combination Product: Allograft and rHPDGF-BB, Combination Product: Allograft and Saline solutionWill be used Demineralized cancellous allograft 250-1000um |
| Saline Solution | Sham comparator | Combination Product: Allograft and Saline solutionThe saline solution will be used for hydrate the bone graft 20 minutes before the placement at the defect |
| rhPDGF-BB (GEM21, Lynch Biologics) | Experimental | Combination Product: Allograft and rHPDGF-BBThe rhPDGF-BB will be used for hydrate the bone graft 20 minutes before the placement at the defect |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of periodontitis
- Infrabony defects of 2 walls, 3 walls and combined defects
- Patients ASA (American Society of Anesthesiologists) I and II
- Patients who smoke less than 10 cigarettes
Key exclusion criteria (4 listed)
- Patients undergoing bisphosphonate therapy
- Furcation defects
- Patients with evidence of blood dyscrasias.
- Pregnant patient
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 |
|---|---|---|
| Allograft and rHPDGF-BBAlso: GEM21, AllograftAt this intervention the periodontal defect will be treated with allograft and rHPDGF-BB (GEM21) | Combination product | Allograft, rhPDGF-BB (GEM21, Lynch Biologics) |
| Allograft and Saline solutionThis will be used as the control group | Combination product | Allograft, Saline Solution |
Primary outcome
Probing depth
Time frame: Initial and six months after surgery
The distance from free gingival margin to sulcus depth, ≥4 millimeters (mm)
Bleeding on probing
Time frame: Initial and six months after surgery
Method to asses gingival inflammation. Gingival health is defined as < 10% bleeding sites
Gingival Recession
Time frame: Initial and six months after surgery
The distance from the soft tissue (gingiva or alveolar mucosa) margin to cemento-enamel junction, ≥1 millimeters (mm)
Clinical Attachment Level
Time frame: Initial and six months after surgery
The distance from the cemento-enamel junction to the tip of a periodontal probe during periodontal diagnostic probing, ≥2 mm (millimeters)
Gingival Phenotype
Time frame: Initial and six months after surgery
Gingival phenotype is determined by gingival thickness and keratinized tissue width. Probe visible: thin (≤1 mm). Probe not visible: thick (>1mm).
Plaque control record
Time frame: Initial and six months after surgery
O'Leary index is used for assessing oral hygiene skills of the patient
Radiographic Measurements
Time frame: Initial and six months after surgery
Cemento-enamel junction (CEJ)-Defect Base (DB): The distance of the cementoenamel junction at the base of the defect. Cemento-enamel junction (CEJ)-Bone crest (BC): The distance of the cemento-enamel junction to the crest of bone. Cemento-enamel junction (CEJ)- Root apex (RA): The distance of the cemento-enamel junction to root apex. Lineal Bone Growth (LBG) = CEJ to base of defect at baseline - CEJ to base of defect at 6 months. %BF: Percent bone fill was calculated by dividing LBG by the depth of the original bone defect
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- Background: PubMed 36281628McClain PK. The use of recombinant human platelet-derived growth factor-BB in combination with beta-tricalcium phosphate and rhPDGF-BB in combination with freeze-dried bone allograft plus barrier in two separate complex infrabony defects with long-term follow-up. Clin Adv Periodontics. 2022 Dec;12(4):256-261. doi: 10.1002/cap.10212. Epub 2022 Oct 25.
- Background: PubMed 14584860Nevins M, Camelo M, Nevins ML, Schenk RK, Lynch SE. Periodontal regeneration in humans using recombinant human platelet-derived growth factor-BB (rhPDGF-BB) and allogenic bone. J Periodontol. 2003 Sep;74(9):1282-92. doi: 10.1902/jop.2003.74.9.1282.
- Results publication: PubMed 16332231Nevins M, Giannobile WV, McGuire MK, Kao RT, Mellonig JT, Hinrichs JE, McAllister BS, Murphy KS, McClain PK, Nevins ML, Paquette DW, Han TJ, Reddy MS, Lavin PT, Genco RJ, Lynch SE. Platelet-derived growth factor stimulates bone fill and rate of attachment level gain: results of a large multicenter randomized controlled trial. J Periodontol. 2005 Dec;76(12):2205-15. doi: 10.1902/jop.2005.76.12.2205.
- Results publication: PubMed 22612364Nevins M, Kao RT, McGuire MK, McClain PK, Hinrichs JE, McAllister BS, Reddy MS, Nevins ML, Genco RJ, Lynch SE, Giannobile WV. Platelet-derived growth factor promotes periodontal regeneration in localized osseous defects: 36-month extension results from a randomized, controlled, double-masked clinical trial. J Periodontol. 2013 Apr;84(4):456-64. doi: 10.1902/jop.2012.120141. Epub 2012 May 21.
- Individual participant dataSharing planned: No
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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.
Jessica P Arredondo Muñoz, Resident principal investigator
Posgrado De Periodoncia, Universidad autónoma de Nuevo León
Maria Fernanda Treviño Campa, Resident principal investigator
Posgrado De Periodoncia, Universidad autónoma de Nuevo León
Gloria Martínez Sandoval, DR study director
Posgrado De Periodoncia, Universidad autónoma de Nuevo León
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Allograft and rHPDGF-BB and Allograft and Saline solution in people with Periodontal Diseases, run by Universidad Autonoma de Nuevo Leon at 1 site in Mexico.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 1 May 2024. 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 Mexico. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jesus I Rodriguez Pulido, Dr (52 81 83294000 ext. 3192, jesus.rodriguezpl@uanl.edu.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probing depth (time frame: Initial and six months after surgery). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06162832, which also lists 4 linked publications.
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 1 May 2024.