PeriodontitisPhase 2/3NCT03792113
AUTOLOGOUS FIBRIN GLUE VERSES 4-0 SILK SUTURES IN PERIODONTAL FLAP CLOSURE
A Phase 2/3 study testing Periodontal Flap Surgery, Autologous fibrin glue and 4-0 silk suture in people with Periodontitis, run by KLE Society's Institute of Dental Sciences.
Trial summary
The study is a split mouth study but the interventions for the two different arms will be spaced by a fixed duration in time. Verbal and written consent will be obtained from the patients fulfilling the inclusion and exclusion criteria after briefing them about the procedure. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- Periodontal Flap Surgery, Autologous fibrin glue and 4-0 silk suture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- May 2019to Dec 2020
- Phase
- Phase 2/3
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients diagnosed with periodontitis, with good systemic health and presence of a minimum of 3 teeth with periodontal pocket depth (PPD) of ≥6mm and clinical attachment level (CAL) of ≥5mm (stage 3 periodontitis as described by the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Condition and published by the American Academy of Periodontology) in at least two quadrants will be selected.
Who cannot join
- Patients who have undergone periodontal therapy during the previous 6 months, or exhibit poor plaque control after phase I therapy.
- History of any systemic disease such as diabetes mellitus, hypertension,osteoporosis, unstable or life-threatening conditions, bleeding disorder, undergoing antibiotic or other antimicrobial therapy.
- Patients on drugs like aspirin, blood thinners and anticoagulant therapy
- Patients with history of allergy
- Current or former smokers.
- Mobility of selected teeth.
- Pregnant or lactating women.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: EVALUATION AND COMPARISON OF THE EFFICACY OF AUTOLOGOUS FIBRIN GLUE WITH 4-0 SILK SUTURES IN PERIODONTAL FLAP CLOSURE AND WOUND HEALING - A SPLIT MOUTH RANDOMIZED CONTROLLED TRIAL.
The study is a split mouth study but the interventions for the two different arms will be spaced by a fixed duration in time. Verbal and written consent will be obtained from the patients fulfilling the inclusion and exclusion criteria after briefing them about the procedure. Following phase-1 periodontal therapy, randomisation for the test and control quadrants will be done. Surgical debridement will be done first for the control side to avoid the carry-across effect of fibrin glue. Control and test procedures will be performed with a wash out period of 15days.
Preparation of Autologous fibrin glue :
Read more
- 10 ml of blood will be withdrawn from healthy adult human donor by venous puncture into sodium citrate vials and will be centrifuged for 30 min at 1200 g to obtain platelet-poor plasma (PPP).
- To the solution, fibrinogen and protamine sulphate will be added and will be centrifuged at 1000 g for 5 min to sediment the precipitate and fibrin glue will be procured.
Prior to commencement of periodontal flap surgery GCF collection will be done. Following anaesthesia and elevation of full thickness muco periosteal flap, thorough debridement and root planning of the exposed root surfaces will be done. On the control site, the periodontal flap will be approximated using 4-0 black silk suture. Patients will be instructed to rinse twice daily with 0.12% chlorhexidine and recalled after 7 days for suture removal and post-surgical GCF collection from the control side. After a wash out period of 15 days presurgical GCF sampling along with the surgical procedure will be performed on the test side. The periodontal flap will be approximated on the test site using autologous fibrin glue on the under surface of the raised flap up to 2 mm from the coronal margin and repositioned back on to the root surface. Thereafter, the tissues will be kept in position with a gentle pressure using a wet gauze for 30 - 60 seconds. Persistence of bleeding, stability of tissues 5 minutes after repositioning will be recorded and the amount of fibrin sealant used in the procedure will be determined.Patients will be then recalled after 7 days for evaluation and post-surgical GCF collection from the test site. Clinical parameters will be assessed at 7, 14, 21 and 28 days.
Collection of GCF :
GCF will be collected immediately prior to surgery and on seventh day following surgery from both test and control sites for wound healing assessment. Samples of GCF will be collected from four sites from the surgical site following isolation. Colour - coded, 1-5 microlitre calibrated volumetric micro capillary pipettes will be kept extra-crevicularly for not more than five minutes or until 1 microlitre is collected. The fluid will be immediately transferred to a plastic vial and frozen at -20 degree Celsius for further analysis. Pipettes in sites which do not express any fluid or those contaminated with blood/saliva will be discarded.
Statistical analysis:
The data gathered from the study will be subjected to appropriate statistical analysis. The statistical analysis will be done using:
- Mann-Whitney test
- Wilcoxon signed rank test.
- Conditions
- Periodontitis
- Being tested
- Periodontal Flap Surgery, Autologous fibrin glue, 4-0 silk suture
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal Flap SurgeryProcedure or surgery
Periodontal access flap surgery will be performed in both test site followed by control site in each subject
Autologous fibrin glueOther
Autologous fibrin glue procured from the subject's own venous blood will be used to approximate periodontal flaps following access periodontal surgery
4-0 silk sutureOther
Conventional 4-0 black silk suture will be used to approximate periodontal flaps following access flap surgery
| Study group | Role | What they receive |
|---|---|---|
| Autologous fibrin glue | Experimental | The periodontal flap will be approximated on the test site using autologous fibrin glue on the under surface of the raised flap up to 2 mm from the coronal margin and repositioned back on to the root surface. Thereafter, the tissues will be kept in position with a gentle pressure using a wet gauze for 30 - 60 seconds. Receives: Procedure: Periodontal Flap Surgery; Other: Autologous fibrin glue |
| 4-0 silk suture | Active comparator | The periodontal flap will be approximated using 4-0 black silk suture. Receives: Procedure: Periodontal Flap Surgery; Other: 4-0 silk suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cytokine parameter
Interleukin 1-β will be assessed in GCF using a commercially available Enzyme-linked immunosorbent assay kit (ELISA), specific for human IL-1 β
Measured: Change from baseline to 7days
Secondary outcomes (4)
Oral Hygiene Index
by John C Greene \& Jack Vermilion in 1964 OHI = DI + CI INTERPRETATION Good 0.0-1.2 Fair 1.3-3.0 Poor 3.1-6.0
Measured: Changes from baseline to 7day, 14day, 21day, 28day
Early Wound Healing Index
Index given by Watchel et al in 2005
SCORING CRITERIA:
DEGREE 1-Complete flap closure No fibrin line in the interproximal area DEGREE 2- Complete flap closure Fine fibrin line in the interproximal area DEGREE 3- Complete flap closure Fibrin clot in the interproximal area DEGREE 4- Incomplete flap closure Partial necrosis of interproximal tissue DEGREE 5- Incomplete flap closure Complete necrosis of interproximal tissue
Measured: Changes from baseline to 7th day, 14th day, 21st day and 28th day
Gingival Index
Index given by Loe and Silness in 1963 Scoring criteria 0 = Normal gingiva
- = Mild inflammation, slight change in color, slight edema, no bleeding on probing.
- = Moderate inflammation, redness, edema, and glazing, bleeding on probing.
- = Severe inflammation, marked redness and edema, ulceration, tendency to spontaneous bleeding.
Score 0.1-1.0-Mild gingivitis 1.1-2-Moderate gingivitis 2.1-3.0 Severe gingivitis
Measured: Changes from baseline to 7th day, 14th day, 21st day and 28th day
VAS score
Index given by Freyd in 1923 Scale -1-10 Score Scale: 0-10 Score 0-No pain 1-3: Mild 4-6: Moderate 7-9: severe 10-worst
Measured: Changes from baseline to 7th day, 14th day, 21st day and 28th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2019
- Study startMay 2019 (estimated)
- Primary completionSep 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients diagnosed with periodontitis, in the age group of 18 to 60 years with good systemic health and presence of a minimum of 3 teeth with periodontal pocket depth (PPD) of ≥6mm and clinical attachment level (CAL) of ≥5mm
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KLE Society's Institute of Dental Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Laveena Singhal, KLE Society's Institute of Dental Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03792113
- Sponsor's protocol ID
- nehafibringlue
- Status last verified
- Feb 2019
- First submitted
- 1 Jan 2019
- Last updated
- 5 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For the purpose of confidentiality as will be promised to the participants while signing the informed consent , all individual records except that of the parameters assessed during the study and the photographs taken will remain unshared to the public or fellow researchers
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION AND COMPARISON OF THE EFFICACY OF AUTOLOGOUS FIBRIN GLUE WITH 4-0 SILK SUTURES IN PERIODONTAL FLAP CLOSURE AND WOUND HEALING - A SPLIT MOUTH RANDOMIZED CONTROLLED TRIAL.
- ClinicalTrials.gov ID
- NCT03792113
- Acronym / sponsor ID
- nehafibringlue
- Conditions
- Periodontitis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- KLE Society's Institute of Dental SciencesUniversity, hospital or other
- Study start
- May 2019 (estimated)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 3 Jan 2019 (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 study is a split mouth study but the interventions for the two different arms will be spaced by a fixed duration in time. Verbal and written consent will be obtained from the patients fulfilling the inclusion and exclusion criteria after briefing them about the procedure. Following phase-1 periodontal therapy, randomisation for the test and control quadrants will be done. Surgical debridement will be done first for the control side to avoid the carry-across effect of fibrin glue. Control and test procedures will be performed with a wash out period of 15days.
Preparation of Autologous fibrin glue :
- 10 ml of blood will be withdrawn from healthy adult human donor by venous puncture into sodium citrate vials and will be centrifuged for 30 min at 1200 g to obtain platelet-poor plasma (PPP).
- To the solution, fibrinogen and protamine sulphate will be added and will be centrifuged at 1000 g for 5 min to sediment the precipitate and fibrin glue will be procured.
Prior to commencement of periodontal flap surgery GCF collection will be done. Following anaesthesia and elevation of full thickness muco periosteal flap, thorough debridement and root planning of the exposed root surfaces will be done. On the control site, the periodontal flap will be approximated using 4-0 black silk suture. Patients will be instructed to rinse twice daily with 0.12% chlorhexidine and recalled after 7 days for suture removal and post-surgical GCF collection from the control side. After a wash out period of 15 days presurgical GCF sampling along with the surgical procedure will be performed on the test side. The periodontal flap will be approximated on the test site using autologous fibrin glue on the under surface of the raised flap up to 2 mm from the coronal margin and repositioned back on to the root surface. Thereafter, the tissues will be kept in position with a gentle pressure using a wet gauze for 30 - 60 seconds. Persistence of bleeding, stability of tissues 5 minutes after repositioning will be recorded and the amount of fibrin sealant used in the procedure will be determined.Patients will be then recalled after 7 days for evaluation and post-surgical GCF collection from the test site. Clinical parameters will be assessed at 7, 14, 21 and 28 days.
Collection of GCF :
GCF will be collected immediately prior to surgery and on seventh day following surgery from both test and control sites for wound healing assessment. Samples of GCF will be collected from four sites from the surgical site following isolation. Colour - coded, 1-5 microlitre calibrated volumetric micro capillary pipettes will be kept extra-crevicularly for not more than five minutes or until 1 microlitre is collected. The fluid will be immediately transferred to a plastic vial and frozen at -20 degree Celsius for further analysis. Pipettes in sites which do not express any fluid or those contaminated with blood/saliva will be discarded.
Statistical analysis:
The data gathered from the study will be subjected to appropriate statistical analysis. The statistical analysis will be done using:
- Mann-Whitney test
- Wilcoxon signed rank test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients diagnosed with periodontitis, in the age group of 18 to 60 years with good systemic health and presence of a minimum of 3 teeth with periodontal pocket depth (PPD) of ≥6mm and clinical attachment level (CAL) of ≥5mm
| Arm | Type | Receives |
|---|---|---|
| Autologous fibrin glue | Experimental | Procedure: Periodontal Flap Surgery, Other: Autologous fibrin glueThe periodontal flap will be approximated on the test site using autologous fibrin glue on the under surface of the raised flap up to 2 mm from the coronal margin and repositioned back on to the root surface. Thereafter, the tissues will be kept in position with a gentle pressure using a wet gauze for 30 - 60 seconds. |
| 4-0 silk suture | Active comparator | Procedure: Periodontal Flap Surgery, Other: 4-0 silk sutureThe periodontal flap will be approximated using 4-0 black silk suture. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients diagnosed with periodontitis, with good systemic health and presence of a minimum of 3 teeth with periodontal pocket depth (PPD) of ≥6mm and clinical attachment level (CAL) of ≥5mm (stage 3 periodontitis as described by the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Condition and published by the American Academy of Periodontology) in at least two quadrants will be selected.
Key exclusion criteria (7 listed)
- Patients who have undergone periodontal therapy during the previous 6 months, or exhibit poor plaque control after phase I therapy.
- History of any systemic disease such as diabetes mellitus, hypertension,osteoporosis, unstable or life-threatening conditions, bleeding disorder, undergoing antibiotic or other antimicrobial therapy.
- Patients on drugs like aspirin, blood thinners and anticoagulant therapy
- Patients with history of allergy
- Current or former 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 |
|---|---|---|
| Periodontal Flap SurgeryPeriodontal access flap surgery will be performed in both test site followed by control site in each subject | Procedure or surgery | 4-0 silk suture, Autologous fibrin glue |
| Autologous fibrin glueAutologous fibrin glue procured from the subject's own venous blood will be used to approximate periodontal flaps following access periodontal surgery | Other | Autologous fibrin glue |
| 4-0 silk sutureConventional 4-0 black silk suture will be used to approximate periodontal flaps following access flap surgery | Other | 4-0 silk suture |
Primary outcome
Cytokine parameter
Time frame: Change from baseline to 7days
Interleukin 1-β will be assessed in GCF using a commercially available Enzyme-linked immunosorbent assay kit (ELISA), specific for human IL-1 β
4 secondary outcomes
Oral Hygiene Index
Time frame: Changes from baseline to 7day, 14day, 21day, 28day
Early Wound Healing Index
Time frame: Changes from baseline to 7th day, 14th day, 21st day and 28th day
Gingival Index
Time frame: Changes from baseline to 7th day, 14th day, 21st day and 28th day
VAS score
Time frame: Changes from baseline to 7th day, 14th day, 21st day and 28th day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
- Individual participant dataSharing planned: No. For the purpose of confidentiality as will be promised to the participants while signing the informed consent , all individual records except that of the parameters assessed during the study and the photographs taken will remain unshared to the public or fellow researchers
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Periodontal Flap Surgery, Autologous fibrin glue and 4-0 silk suture in people with Periodontitis, run by KLE Society's Institute of Dental Sciences.
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 1 inclusion and 7 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 5 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Neha Pradhan, BDS, Post graduate student (9620508212 ext. +91, pradhanneha92@yahoo.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cytokine parameter (time frame: Change from baseline to 7days). 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 5 Feb 2019.