Chronic PeriodontitisPhase 4NCT04767243
Regenerative Potential of Advanced Platelet Rich Fibrin and Bioactive Glass (Perioglas®).
A Phase 4 study testing open flap debridement and filled with A-PRF ( Advanced platelet rich fibrin), open flap debridement and filled with Bioactive glass (Perioglas®) and open flap debridement and filled Bioactive glass (Perioglas®) and A-PRF in people with Chronic Periodontitis and Bone Loss, run by Maharishi Markendeswar University (Deemed to be University) at 1 site in India.
Trial summary
The aim of this study is to evaluate and compare the regenerative potential of Advanced Platelet Rich Fibrin (A-PRF) and Bioactive Glass (Perioglas®) bone graft in the treatment of intrabony defects in chronic periodontitis patients. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Periodontitis, Bone Loss, Intrabony Periodontal Defect
- What is being tested?
- open flap debridement and filled with A-PRF ( Advanced platelet rich fibrin), open flap debridement and filled with Bioactive glass (Perioglas®) and open flap debridement and filled Bioactive glass (Perioglas®) and A-PRF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteIndia
- Study dates
- 1 Dec 2020to 4 Mar 2022
- Phase
- Phase 4
- 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 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 25 to 55 years.
- Gender: Both males and females will be included in the study.
- Co-operative and motivated patients committed to oral hygiene.
- Patients exhibiting intrabony defects.
Who cannot join
- Patients with contraindication to periodontal surgery \& local anesthesia.
- Any systemic disease affecting the bone density and outcome of periodontal therapy.
- Smokers, alcoholics, and patients with other adverse habits.
- Pregnant, nursing and menopausal women.
- Any known allergy/ hypersensitivity to any product used in this study.
- Patients on long-term systemic therapy (antibiotics, anti-inflammatory bisphosphonates, hormonal replacement therapy and any other), taking any drug known to have periodontal implications that may interfere with wound healing.
- Patients taking any anti-platelet and anticoagulant medication.
- Patients who have undergone periodontal treatment within a period of past 1 year.
Trial locations and contacts
1 site in 1 country.
India1 site
Department of Periodontology, M.M. College of Dental Sciences and Research.
Ambāla, Haryana, 133207
About this study
Official title: Regenerative Potential of Advanced Platelet Rich Fibrin (A-PRF) and Bioactive Glass (Perioglas®) Bone Graft in the Treatment of Intrabony Defects; A Comparative Clinico Radiographic Study.
The aim of this study is to evaluate and compare the regenerative potential of Advanced Platelet Rich Fibrin (A-PRF) and Bioactive Glass (Perioglas®) bone graft in the treatment of intrabony defects in chronic periodontitis patients.
Read the detailed description
45 sites with vertical intrabony alveolar defects will be selected. These defect sites will be allocated randomly into 3 groups as Group I, Group II and Group III.
- Group I will be treated with open flap debridement and filled with A-PRF
- Group II will be treated with open flap debridement and filled with Bioactive glass (Perioglas®)
- Group III will be treated with open flap debridement and filled Bioactive glass (Perioglas®) and A-PRF.
- Being tested
- open flap debridement and filled with A-PRF ( Advanced platelet rich fibrin), open flap debridement and filled with Bioactive glass (Perioglas®), open flap debridement and filled Bioactive glass (Perioglas®) and A-PRF
- Keywords
- intrabony periodontal defect, regeneration, platelet rich fibrin, bioactive glass
- Medical subject headings
- Chronic Periodontitis, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
open flap debridement and filled with A-PRF ( Advanced platelet rich fibrin)Procedure or surgery
After phase 1 therapy, surgical procedure would be carried out in the selected patients under aseptic conditions. Full thickness mucoperiosteal Kirkland flap would be raised on both buccal and lingual sides using periosteal elevator. Pocket lining epithelium would be removed and a thorough debridement and root planing would be done in the intrabony defect by using Gracey curettes and universal curettes. After placement of A-PRF in bony defect site the mucoperiosteal flaps would be sutured for complete soft tissue closure.
open flap debridement and filled with Bioactive glass (Perioglas®)Procedure or surgery
Also called perioglas
After phase 1 therapy, surgical procedure would be carried out in the selected patients under aseptic conditions. Full thickness mucoperiosteal Kirkland flap would be raised on both buccal and lingual sides using periosteal elevator. Pocket lining epithelium would be removed and a thorough debridement and root planing would be done in the intrabony defect by using Gracey curettes and universal curettes. After placement of perioglas in bony defect site the mucoperiosteal flaps would be sutured for complete soft tissue closure.
open flap debridement and filled Bioactive glass (Perioglas®) and A-PRFDrug
Also called perioglas
After phase 1 therapy, surgical procedure would be carried out in the selected patients under aseptic conditions. Full thickness mucoperiosteal Kirkland flap would be raised on both buccal and lingual sides using periosteal elevator. Pocket lining epithelium would be removed and a thorough debridement and root planing would be done in the intrabony defect by using Gracey curettes and universal curettes. After placement of perioglas with A-PRF in bony defect site the mucoperiosteal flaps would be sutured for complete soft tissue closure.
| Study group | Role | What they receive |
|---|---|---|
| open flap debridement and filled with A-PRF | Sham comparator | After phase 1 therapy, surgical procedure would be carried out in the selected patients under aseptic conditions. Full thickness mucoperiosteal Kirkland flap would be raised on both buccal and lingual sides using periosteal elevator. Pocket lining epithelium would be removed and a thorough debridement and root planing would be done in the intrabony defect by using Gracey curettes and universal curettes. After placement of A-PRF in bony defect site the mucoperiosteal flaps would be sutured for complete soft tissue closure. Receives: Procedure: open flap debridement and filled with A-PRF ( Advanced platelet rich fibrin) |
| open flap debridement and filled with Bioactive glass (Perioglas®) | Active comparator | After phase 1 therapy, surgical procedure would be carried out in the selected patients under aseptic conditions. Full thickness mucoperiosteal Kirkland flap would be raised on both buccal and lingual sides using periosteal elevator. Pocket lining epithelium would be removed and a thorough debridement and root planing would be done in the intrabony defect by using Gracey curettes and universal curettes. After placement of Bioactive glass (Perioglas®) in bony defect site the mucoperiosteal flaps would be sutured for complete soft tissue closure. Receives: Procedure: open flap debridement and filled with Bioactive glass (Perioglas®) |
| with open flap debridement and filled Bioactive glass (Perioglas®) and A-PRF. | Active comparator | After phase 1 therapy, surgical procedure would be carried out in the selected patients under aseptic conditions. Full thickness mucoperiosteal Kirkland flap would be raised on both buccal and lingual sides using periosteal elevator. Pocket lining epithelium would be removed and a thorough debridement and root planing would be done in the intrabony defect by using Gracey curettes and universal curettes. After placement of Bioactive glass (Perioglas®) along with A-PRF in bony defect site the mucoperiosteal flaps would be sutured for complete soft tissue closure. Receives: Drug: open flap debridement and filled Bioactive glass (Perioglas®) and A-PRF |
What is being measured
The primary outcome is the main question the study is designed to answer.
probing depth
change in probing pocket depth
Measured: baseline, 3 months, 6 months
relative attachment level
change in attachment level
Measured: baseline, 3 months, 6 months
radiographic linear bone change
radiographic linear bone change through radiographic grid
Measured: change from baseline to 6 months
Secondary outcomes (2)
Plaque index site specific
Plaque index -Silness and Loe
Measured: baseline, 3 months, 6 months
Gingival index site specific
Gingival index- Loe and Silness
Measured: baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start1 Dec 2020
- Primary completion18 Feb 2022
- Study completion4 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic PeriodontitisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 45 sites with vertical intrabony alveolar defects will be selected. These defect sites will be allocated randomly into 3 groups as Group I, Group II and Group III. * Group I will be treated with open flap debridement and filled with A-PRF * Group II will be treated with open flap debridement and filled with Bioactive glass (Perioglas®) * Group III will be treated with open flap debridement and filled Bioactive glass (Perioglas®) and A-PRF.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maharishi Markendeswar University (Deemed to be University)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DR SURINDER SACHDEVA, Maharishi Markendeswar University (Deemed to be University)
- Investigators
- surinder sachdeva, M.D.S., Principal investigator, PROFESSOR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04767243
- Sponsor's protocol ID
- 1597
- Status last verified
- Nov 2022
- First submitted
- 9 Feb 2021
- Last updated
- 8 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ghanaati S, Booms P, Orlowska A, Kubesch A, Lorenz J, Rutkowski J, Landes C, Sader R, Kirkpatrick C, Choukroun J. Advanced platelet-rich fibrin: a new concept for cell-based tissue engineering by means of inflammatory cells. J Oral Implantol. 2014 Dec;40(6):679-89. doi: 10.1563/aaid-joi-D-14-00138.
PubMed 24945603Mengel R, Schreiber D, Flores-de-Jacoby L. Bioabsorbable membrane and bioactive glass in the treatment of intrabony defects in patients with generalized aggressive periodontitis: results of a 5-year clinical and radiological study. J Periodontol. 2006 Oct;77(10):1781-7. doi: 10.1902/jop.2006.060029.
PubMed 17032123
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regenerative Potential of Advanced Platelet Rich Fibrin (A-PRF) and Bioactive Glass (Perioglas®) Bone Graft in the Treatment of Intrabony Defects; A Comparative Clinico Radiographic Study.
- ClinicalTrials.gov ID
- NCT04767243
- Acronym / sponsor ID
- 1597
- Keywords
- intrabony periodontal defect, regeneration, platelet rich fibrin, bioactive glass
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Maharishi Markendeswar University (Deemed to be University)University, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 18 Feb 2022 (actual)
- Study completion
- 4 Mar 2022 (actual)
- First posted
- 23 Feb 2021 (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.
The aim of this study is to evaluate and compare the regenerative potential of Advanced Platelet Rich Fibrin (A-PRF) and Bioactive Glass (Perioglas®) bone graft in the treatment of intrabony defects in chronic periodontitis patients.
Detailed description
45 sites with vertical intrabony alveolar defects will be selected. These defect sites will be allocated randomly into 3 groups as Group I, Group II and Group III.
- Group I will be treated with open flap debridement and filled with A-PRF
- Group II will be treated with open flap debridement and filled with Bioactive glass (Perioglas®)
- Group III will be treated with open flap debridement and filled Bioactive glass (Perioglas®) and A-PRF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- 45 sites with vertical intrabony alveolar defects will be selected. These defect sites will be allocated randomly into 3 groups as Group I, Group II and Group III. * Group I will be treated with open flap debridement and filled with A-PRF * Group II will be treated with open flap debridement and filled with Bioactive glass (Perioglas®) * Group III will be treated with open flap debridement and filled Bioactive glass (Perioglas®) and A-PRF.
| Arm | Type | Receives |
|---|---|---|
| open flap debridement and filled with A-PRF | Sham comparator | Procedure: open flap debridement and filled with A-PRF ( Advanced platelet rich fibrin)After phase 1 therapy, surgical procedure would be carried out in the selected patients under aseptic conditions. Full thickness mucoperiosteal Kirkland flap would be raised on both buccal and lingual sides using periosteal elevator. Pocket lining epithelium would be removed and a thorough debridement and root planing would be done in the intrabony defect by using Gracey curettes and universal curettes. After placement of A-PRF in bony defect site the mucoperiosteal flaps would be sutured for complete soft tissue closure. |
| open flap debridement and filled with Bioactive glass (Perioglas®) | Active comparator | Procedure: open flap debridement and filled with Bioactive glass (Perioglas®)After phase 1 therapy, surgical procedure would be carried out in the selected patients under aseptic conditions. Full thickness mucoperiosteal Kirkland flap would be raised on both buccal and lingual sides using periosteal elevator. Pocket lining epithelium would be removed and a thorough debridement and root planing would be done in the intrabony defect by using Gracey curettes and universal curettes. After placement of Bioactive glass (Perioglas®) in bony defect site the mucoperiosteal flaps would be sutured for complete soft tissue closure. |
| with open flap debridement and filled Bioactive glass (Perioglas®) and A-PRF. | Active comparator | Drug: open flap debridement and filled Bioactive glass (Perioglas®) and A-PRFAfter phase 1 therapy, surgical procedure would be carried out in the selected patients under aseptic conditions. Full thickness mucoperiosteal Kirkland flap would be raised on both buccal and lingual sides using periosteal elevator. Pocket lining epithelium would be removed and a thorough debridement and root planing would be done in the intrabony defect by using Gracey curettes and universal curettes. After placement of Bioactive glass (Perioglas®) along with A-PRF in bony defect site the mucoperiosteal flaps would be sutured for complete soft tissue closure. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age: 25 to 55 years.
- Gender: Both males and females will be included in the study.
- Co-operative and motivated patients committed to oral hygiene.
- Patients exhibiting intrabony defects.
Key exclusion criteria (8 listed)
- Patients with contraindication to periodontal surgery \& local anesthesia.
- Any systemic disease affecting the bone density and outcome of periodontal therapy.
- Smokers, alcoholics, and patients with other adverse habits.
- Pregnant, nursing and menopausal women.
- Any known allergy/ hypersensitivity to any product used in this study.
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 |
|---|---|---|
| open flap debridement and filled with A-PRF ( Advanced platelet rich fibrin)After phase 1 therapy, surgical procedure would be carried out in the selected patients under aseptic conditions. Full thickness mucoperiosteal Kirkland flap would be raised on both buccal and lingual sides using periosteal elevator. Pocket lining epithelium would be removed and a thorough debridement and root planing would be done in the intrabony defect by using Gracey curettes and universal curettes. After placement of A-PRF in bony defect site the mucoperiosteal flaps would be sutured for complete soft tissue closure. | Procedure or surgery | open flap debridement and filled with A-PRF |
| open flap debridement and filled with Bioactive glass (Perioglas®)Also: perioglasAfter phase 1 therapy, surgical procedure would be carried out in the selected patients under aseptic conditions. Full thickness mucoperiosteal Kirkland flap would be raised on both buccal and lingual sides using periosteal elevator. Pocket lining epithelium would be removed and a thorough debridement and root planing would be done in the intrabony defect by using Gracey curettes and universal curettes. After placement of perioglas in bony defect site the mucoperiosteal flaps would be sutured for complete soft tissue closure. | Procedure or surgery | open flap debridement and filled with Bioactive glass (Perioglas®) |
| open flap debridement and filled Bioactive glass (Perioglas®) and A-PRFAlso: perioglasAfter phase 1 therapy, surgical procedure would be carried out in the selected patients under aseptic conditions. Full thickness mucoperiosteal Kirkland flap would be raised on both buccal and lingual sides using periosteal elevator. Pocket lining epithelium would be removed and a thorough debridement and root planing would be done in the intrabony defect by using Gracey curettes and universal curettes. After placement of perioglas with A-PRF in bony defect site the mucoperiosteal flaps would be sutured for complete soft tissue closure. | Drug | with open flap debridement and filled Bioactive glass (Perioglas®) and A-PRF. |
Primary outcome
probing depth
Time frame: baseline, 3 months, 6 months
change in probing pocket depth
relative attachment level
Time frame: baseline, 3 months, 6 months
change in attachment level
radiographic linear bone change
Time frame: change from baseline to 6 months
radiographic linear bone change through radiographic grid
2 secondary outcomes
Plaque index site specific
Time frame: baseline, 3 months, 6 months
Gingival index site specific
Time frame: baseline, 3 months, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Background: PubMed 24945603Ghanaati S, Booms P, Orlowska A, Kubesch A, Lorenz J, Rutkowski J, Landes C, Sader R, Kirkpatrick C, Choukroun J. Advanced platelet-rich fibrin: a new concept for cell-based tissue engineering by means of inflammatory cells. J Oral Implantol. 2014 Dec;40(6):679-89. doi: 10.1563/aaid-joi-D-14-00138.
- Background: PubMed 17032123Mengel R, Schreiber D, Flores-de-Jacoby L. Bioabsorbable membrane and bioactive glass in the treatment of intrabony defects in patients with generalized aggressive periodontitis: results of a 5-year clinical and radiological study. J Periodontol. 2006 Oct;77(10):1781-7. doi: 10.1902/jop.2006.060029.
- 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.
surinder sachdeva, M.D.S. principal investigator
PROFESSOR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing open flap debridement and filled with A-PRF ( Advanced platelet rich fibrin), open flap debridement and filled with Bioactive glass (Perioglas®) and open flap debridement and filled Bioactive glass (Perioglas®) and A-PRF in people with Chronic Periodontitis and Bone Loss, run by Maharishi Markendeswar University (Deemed to be University) at 1 site in India.
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 8 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 8 Nov 2022. 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 India. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
probing depth (time frame: baseline, 3 months, 6 months). The study lists 3 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 NCT04767243, which also lists 2 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 8 Nov 2022.