Chronic PeriodontitisNCT04207034
Effect of the Diode Laser on Bacteremia Associated With Periodontal Flap Surgery: A Clinico-Microbiological Study
A study testing flap surgery with diode laser and flap surgery in people with Chronic Periodontitis, run by Krishnadevaraya College of Dental Sciences & Hospital at 1 site in India.
Trial summary
The objective of the present study is 1. To study the incidence and magnitude of bacteremia after periodontal flap surgery . 2. To compare and evaluate the effect of diode laser on frequency of bacteremia associated with periodontal flap surgery . 3. To study the incidence of bacteremia after laser therapy Read more about this study
- Who is it for?
- Ages 30 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- flap surgery with diode laser and flap surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jan 2020to 10 Jan 2021
- Phase
- Interventional
- 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 30 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult patient with age 30 -40 years .
- Systemically healthy patients.
- Patients having probing depth of ≥ 5mm and ≤ 8 mm at minimum of two sites and good level of oral hygiene after initial therapy.
- No signs of gingival inflammation
Who cannot join
- Patient with history of smoking, antibiotic therapy within the previous three months.
- Patient with subgingival restorations and use of antiseptic mouthwash.
- Congenital or acquired cardiac defects, cardiac prosthesis.
- Hematological disorder.
- Immunocompromised patients
- -
Trial locations and contacts
1 site in 1 country.
About this study
The objective of the present study is
- To study the incidence and magnitude of bacteremia after periodontal flap surgery .
- To compare and evaluate the effect of diode laser on frequency of bacteremia associated with periodontal flap surgery .
- To study the incidence of bacteremia after laser therapy
Read the detailed description
SOURCE OF DATA Patient visiting the Outpatient Section of the Department of Periodontology, Krishnadevaraya College of Dental Sciences and Hospital will be screened and randomly recruited for the study as per inclusion and exclusion criteria. The eligible subjects will be informed of the nature and benefits of the participation of the study and a written signed consent will be obtained. The study population will consist of twenty (n=20) subjects who will be age (30 to 40 years) and sex matched.
Sample Size The study was performed according to split- mouth design, and all teeth in the mouth were treated randomly using either the left or the right side of the maxilla and mandible for control , and the opposite side for the therapy. Each patient was entered into a clinical protocol consisting of two different treatment modalities.
Group I (n=10) - Test group ( diode laser + flap surgery) Group II (n=10) - control group (flap surgery)
SURGICAL PROCEDURE GROUP I (TEST GROUP) Patient will be asked to rinse with 0.2% chlorhexidine mouthwash. Following the administration of local anaesthesia 2% lignocaine hydrochloride ( with 1: 80,000 epinephrine) , Laser application will be carried out , with the help of 810 nm (A.R.C LASER FoxTM) diode laser with a flexible optic tip of 300µm . The sulci will be lased with a repeated beam ( 0.2 sec on 0.3 sec off) at an output power of 1.0 W.
Intracrevicular incision will be placed with the help of 15c Bard Parker surgical blade , full thickness mucoperiosteal flap will be elevated .
Debridement of granulation tissue will be done and flap will be suture back in position using 3-0 black breaded silk suture, the site will be covered with non eugenol periodontal dressing for protection.
Postoperative instructions will be given to the patient. 2 ml blood will be collected at baseline(sample 1) , at 5 minutes (sample 2) and within 20-30 minutes (sample 3) of starting the procedure.
GROUP II (CONTROL GROUP) Patient will be asked to rinse with 0.2% chlorhexidine mouthwash. Following the administration of local anaesthesia 2% lignocaine hydrochloride ( with 1:80,000 epinephrine) ,intracrevicular incision will be placed with the help of 15c Bard Parker surgical blade , full thickness mucoperiosteal flap will be elevated .
Debridement of granulation tissue will be done and flap will be suture back in position using 3-0 black breaded silk suture, the site will be covered with non eugenol periodontal dressing for protection.
Postoperative instructions will be given to the patient. 2 ml blood will be collected at baseline(sample 1) , at 5 minutes (sample 2) and within 20-30 minutes (sample 3) of starting the procedure
Collection of blood samples Six millilitres (6 ml) of blood samples will be drawn from the patient through an antecubital vein using strict aseptic technique via a 22- gauge sterile plastic cannula and sent for for qPCR analysis to quantify total bacterial load.
PCR ANALYSIS The polymerase chain reaction (PCR) is a laboratory technique for DNA replication that allows the "target" DNA sequence to be selectively amplified. The PCR involves the primer mediated enzymatic amplification of DNA. In this study Quantitive polymerase chain reaction is done.
- DNA from the blood samples will be extracted using the QIAamp DNA Blood Mini Kit according to the manufacture's recommendations.
- In order to quantify the total bacterial load, qPCR will be carried out using a universal primer to the 16S ribosomal RNA gene.
- Analysis was performed in a total volume of 6 ml blood.
- Samples for qPCR will be dispensed into well plates, sealed and centrifuged.
- Amplification will be done , settings for qPCR will be as follows: 95 degree centigrade for 10 minutes followed by 40 amplification cycles at 95 degree centigrade for 1 minute, 52 degree centigrade for 1 minute , 72 degree centigrade for 1 minute.
- After each cycle , PCR products will be monitored for the increase in fluorescence of SYBR green.
- All measurements will be performed in triplicate for both test and controls.
- For the negative control , ultrapure water will be used replacing the clinical sample.
- To determine the specificity of the amplified products, a melting curve will be obtained from 60 degree centigrade to ninty five degree centigrade, with continuous florescence measurement at each 1% increase in temperature.
- Data acquisition and analysis will be performed using the ABI 7500 software.
Statistical analysis Data will be subjected for normality test. Best on the data parametric or non parametric test will be performed. P value < 0.05 will be considered statistically significant.
- Conditions
- Chronic Periodontitis
- Being tested
- flap surgery with diode laser, flap surgery
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flap surgery with diode laserProcedure or surgery
Patient will be asked to rinse with 0.2% chlorhexidine mouthwash. Following the administration of local anaesthesia 2% lignocaine hydrochloride ( with 1: 80,000 epinephrine) , Laser application will be carried out , with the help of 810 nm (A.R.C LASER FoxTM) diode laser with a flexible optic tip of 300µm . The sulci will be lased with a repeated beam ( 0.2 sec on 0.3 sec off) at an output power of 1.0 W.
Intracrevicular incision will be placed with the help of 15c Bard Parker surgical blade , full thickness mucoperiosteal flap will be elevated .
Debridement of granulation tissue will be done and flap will be suture back in position using 3-0 black breaded silk suture, the site will be covered with non eugenol periodontal dressing for protection.
Postoperative instructions will be given to the patient. 2 ml blood will be collected at baseline(sample 1) , at 5 minutes (sample 2) and within 20-30 minutes (sample 3) of starting the procedure.
flap surgeryProcedure or surgery
Patient will be asked to rinse with 0.2% chlorhexidine mouthwash. Following the administration of local anaesthesia 2% lignocaine hydrochloride ( with 1:80,000 epinephrine) ,intracrevicular incision will be placed with the help of 15c Bard Parker surgical blade , full thickness mucoperiosteal flap will be elevated .
Debridement of granulation tissue will be done and flap will be suture back in position using 3-0 black breaded silk suture, the site will be covered with non eugenol periodontal dressing for protection.
Postoperative instructions will be given to the patient. 2 ml blood will be collected at baseline(sample 1) , at 5 minutes (sample 2) and within 20-30 minutes (sample 3) of starting the procedure
| Study group | Role | What they receive |
|---|---|---|
| flap surgery and diode laser | Experimental | Patient will be asked to rinse with 0.2% chlorhexidine mouthwash. Following the administration of local anaesthesia 2% lignocaine hydrochloride ( with 1: 80,000 epinephrine) , Laser application will be carried out , with the help of 810 nm (A.R.C LASER FoxTM) diode laser with a flexible optic tip of 300µm . The sulci will be lased with a repeated beam ( 0.2 sec on 0.3 sec off) at an output power of 1.0 W.
Intracrevicular incision will be placed with the help of 15c Bard Parker surgical blade , full thickness mucoperiosteal flap will be elevated .
Debridement of granulation tissue will be done and flap will be suture back in position using 3-0 black breaded silk suture, the site will be covered with non eugenol periodontal dressing for protection.
Postoperative instructions will be given to the patient. 2 ml blood will be collected at baseline(sample 1) , at 5 minutes (sample 2) and within 20-30 minutes (sample 3) of starting the procedure. Receives: Procedure: flap surgery with diode laser |
| flap surgery | Active comparator | Patient will be asked to rinse with 0.2% chlorhexidine mouthwash. Following the administration of local anaesthesia 2% lignocaine hydrochloride ( with 1:80,000 epinephrine) ,intracrevicular incision will be placed with the help of 15c Bard Parker surgical blade , full thickness mucoperiosteal flap will be elevated .
Debridement of granulation tissue will be done and flap will be suture back in position using 3-0 black breaded silk suture, the site will be covered with non eugenol periodontal dressing for protection.
Postoperative instructions will be given to the patient. 2 ml blood will be collected at baseline(sample 1) , at 5 minutes (sample 2) and within 20-30 minutes (sample 3) of starting the procedure Receives: Procedure: flap surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of bacteremia using PCR
Bacteremia in venous blood before starting the procedure, after 5 minutes and within 30 minutes of the start of the procedure
Measured: After 24 hours of collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2019
- Study start1 Jan 2020
- Primary completion30 Dec 2020 (estimated)
- Study completion10 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study was performed according to split- mouth design, and all teeth in the mouth were treated randomly using either the left or the right side of the maxilla and mandible for control , and the opposite side for the therapy. Each patient was entered into a clinical protocol consisting of two different treatment modalities. Group I (n=10) - Test group ( diode laser + flap surgery) Group II (n=10) - control group (flap surgery)
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Prabhuji MLV, Krishnadevaraya College of Dental Sciences & Hospital
- Investigators
- Akanksha Dubey, MDS, Principal investigator, Rajiv Gandhi University of Health SciencesMLV Prabhuji, MDS, Study director, Rajiv Gandhi University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04207034
- Sponsor's protocol ID
- 02_D012_91549
- Status last verified
- Dec 2020
- First submitted
- 10 Dec 2019
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Diode Laser on Bacteremia Associated With Periodontal Flap Surgery: A Clinico-Microbiological Study
- ClinicalTrials.gov ID
- NCT04207034
- Acronym / sponsor ID
- 02_D012_91549
- Conditions
- Chronic Periodontitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Krishnadevaraya College of Dental Sciences & HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 10 Jan 2021 (estimated)
- First posted
- 20 Dec 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 objective of the present study is
- To study the incidence and magnitude of bacteremia after periodontal flap surgery .
- To compare and evaluate the effect of diode laser on frequency of bacteremia associated with periodontal flap surgery .
- To study the incidence of bacteremia after laser therapy
Detailed description
SOURCE OF DATA Patient visiting the Outpatient Section of the Department of Periodontology, Krishnadevaraya College of Dental Sciences and Hospital will be screened and randomly recruited for the study as per inclusion and exclusion criteria. The eligible subjects will be informed of the nature and benefits of the participation of the study and a written signed consent will be obtained. The study population will consist of twenty (n=20) subjects who will be age (30 to 40 years) and sex matched.
Sample Size The study was performed according to split- mouth design, and all teeth in the mouth were treated randomly using either the left or the right side of the maxilla and mandible for control , and the opposite side for the therapy. Each patient was entered into a clinical protocol consisting of two different treatment modalities.
Group I (n=10) - Test group ( diode laser + flap surgery) Group II (n=10) - control group (flap surgery)
SURGICAL PROCEDURE GROUP I (TEST GROUP) Patient will be asked to rinse with 0.2% chlorhexidine mouthwash. Following the administration of local anaesthesia 2% lignocaine hydrochloride ( with 1: 80,000 epinephrine) , Laser application will be carried out , with the help of 810 nm (A.R.C LASER FoxTM) diode laser with a flexible optic tip of 300µm . The sulci will be lased with a repeated beam ( 0.2 sec on 0.3 sec off) at an output power of 1.0 W.
Intracrevicular incision will be placed with the help of 15c Bard Parker surgical blade , full thickness mucoperiosteal flap will be elevated .
Debridement of granulation tissue will be done and flap will be suture back in position using 3-0 black breaded silk suture, the site will be covered with non eugenol periodontal dressing for protection.
Postoperative instructions will be given to the patient. 2 ml blood will be collected at baseline(sample 1) , at 5 minutes (sample 2) and within 20-30 minutes (sample 3) of starting the procedure.
GROUP II (CONTROL GROUP) Patient will be asked to rinse with 0.2% chlorhexidine mouthwash. Following the administration of local anaesthesia 2% lignocaine hydrochloride ( with 1:80,000 epinephrine) ,intracrevicular incision will be placed with the help of 15c Bard Parker surgical blade , full thickness mucoperiosteal flap will be elevated .
Debridement of granulation tissue will be done and flap will be suture back in position using 3-0 black breaded silk suture, the site will be covered with non eugenol periodontal dressing for protection.
Postoperative instructions will be given to the patient. 2 ml blood will be collected at baseline(sample 1) , at 5 minutes (sample 2) and within 20-30 minutes (sample 3) of starting the procedure
Collection of blood samples Six millilitres (6 ml) of blood samples will be drawn from the patient through an antecubital vein using strict aseptic technique via a 22- gauge sterile plastic cannula and sent for for qPCR analysis to quantify total bacterial load.
PCR ANALYSIS The polymerase chain reaction (PCR) is a laboratory technique for DNA replication that allows the "target" DNA sequence to be selectively amplified. The PCR involves the primer mediated enzymatic amplification of DNA. In this study Quantitive polymerase chain reaction is done.
- DNA from the blood samples will be extracted using the QIAamp DNA Blood Mini Kit according to the manufacture's recommendations.
- In order to quantify the total bacterial load, qPCR will be carried out using a universal primer to the 16S ribosomal RNA gene.
- Analysis was performed in a total volume of 6 ml blood.
- Samples for qPCR will be dispensed into well plates, sealed and centrifuged.
- Amplification will be done , settings for qPCR will be as follows: 95 degree centigrade for 10 minutes followed by 40 amplification cycles at 95 degree centigrade for 1 minute, 52 degree centigrade for 1 minute , 72 degree centigrade for 1 minute.
- After each cycle , PCR products will be monitored for the increase in fluorescence of SYBR green.
- All measurements will be performed in triplicate for both test and controls.
- For the negative control , ultrapure water will be used replacing the clinical sample.
- To determine the specificity of the amplified products, a melting curve will be obtained from 60 degree centigrade to ninty five degree centigrade, with continuous florescence measurement at each 1% increase in temperature.
- Data acquisition and analysis will be performed using the ABI 7500 software.
Statistical analysis Data will be subjected for normality test. Best on the data parametric or non parametric test will be performed. P value < 0.05 will be considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study was performed according to split- mouth design, and all teeth in the mouth were treated randomly using either the left or the right side of the maxilla and mandible for control , and the opposite side for the therapy. Each patient was entered into a clinical protocol consisting of two different treatment modalities. Group I (n=10) - Test group ( diode laser + flap surgery) Group II (n=10) - control group (flap surgery)
| Arm | Type | Receives |
|---|---|---|
| flap surgery and diode laser | Experimental | Procedure: flap surgery with diode laserPatient will be asked to rinse with 0.2% chlorhexidine mouthwash. Following the administration of local anaesthesia 2% lignocaine hydrochloride ( with 1: 80,000 epinephrine) , Laser application will be carried out , with the help of 810 nm (A.R.C LASER FoxTM) diode laser with a flexible optic tip of 300µm . The sulci will be lased with a repeated beam ( 0.2 sec on 0.3 sec off) at an output power of 1.0 W. Intracrevicular incision will be placed with the help of 15c Bard Parker surgical blade , full thickness mucoperiosteal flap will be elevated . Debridement of granulation tissue will be done and flap will be suture back in position using 3-0 black breaded silk suture, the site will be covered with non eugenol periodontal dressing for protection. Postoperative instructions will be given to the patient. 2 ml blood will be collected at baseline(sample 1) , at 5 minutes (sample 2) and within 20-30 minutes (sample 3) of starting the procedure. |
| flap surgery | Active comparator | Procedure: flap surgeryPatient will be asked to rinse with 0.2% chlorhexidine mouthwash. Following the administration of local anaesthesia 2% lignocaine hydrochloride ( with 1:80,000 epinephrine) ,intracrevicular incision will be placed with the help of 15c Bard Parker surgical blade , full thickness mucoperiosteal flap will be elevated . Debridement of granulation tissue will be done and flap will be suture back in position using 3-0 black breaded silk suture, the site will be covered with non eugenol periodontal dressing for protection. Postoperative instructions will be given to the patient. 2 ml blood will be collected at baseline(sample 1) , at 5 minutes (sample 2) and within 20-30 minutes (sample 3) of starting the procedure |
Who may qualify
- Ages
- 30 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adult patient with age 30 -40 years .
- Systemically healthy patients.
- Patients having probing depth of ≥ 5mm and ≤ 8 mm at minimum of two sites and good level of oral hygiene after initial therapy.
- No signs of gingival inflammation
Key exclusion criteria (6 listed)
- Patient with history of smoking, antibiotic therapy within the previous three months.
- Patient with subgingival restorations and use of antiseptic mouthwash.
- Congenital or acquired cardiac defects, cardiac prosthesis.
- Hematological disorder.
- Immunocompromised patients
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 |
|---|---|---|
| flap surgery with diode laserPatient will be asked to rinse with 0.2% chlorhexidine mouthwash. Following the administration of local anaesthesia 2% lignocaine hydrochloride ( with 1: 80,000 epinephrine) , Laser application will be carried out , with the help of 810 nm (A.R.C LASER FoxTM) diode laser with a flexible optic tip of 300µm . The sulci will be lased with a repeated beam ( 0.2 sec on 0.3 sec off) at an output power of 1.0 W. Intracrevicular incision will be placed with the help of 15c Bard Parker surgical blade , full thickness mucoperiosteal flap will be elevated . Debridement of granulation tissue will be done and flap will be suture back in position using 3-0 black breaded silk suture, the site will be covered with non eugenol periodontal dressing for protection. Postoperative instructions will be given to the patient. 2 ml blood will be collected at baseline(sample 1) , at 5 minutes (sample 2) and within 20-30 minutes (sample 3) of starting the procedure. | Procedure or surgery | flap surgery and diode laser |
| flap surgeryPatient will be asked to rinse with 0.2% chlorhexidine mouthwash. Following the administration of local anaesthesia 2% lignocaine hydrochloride ( with 1:80,000 epinephrine) ,intracrevicular incision will be placed with the help of 15c Bard Parker surgical blade , full thickness mucoperiosteal flap will be elevated . Debridement of granulation tissue will be done and flap will be suture back in position using 3-0 black breaded silk suture, the site will be covered with non eugenol periodontal dressing for protection. Postoperative instructions will be given to the patient. 2 ml blood will be collected at baseline(sample 1) , at 5 minutes (sample 2) and within 20-30 minutes (sample 3) of starting the procedure | Procedure or surgery | flap surgery |
Primary outcome
Assessment of bacteremia using PCR
Time frame: After 24 hours of collection
Bacteremia in venous blood before starting the procedure, after 5 minutes and within 30 minutes of the start of the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
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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.
Akanksha Dubey, MDS principal investigator
Rajiv Gandhi University of Health Sciences
MLV Prabhuji, MDS study director
Rajiv Gandhi University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing flap surgery with diode laser and flap surgery in people with Chronic Periodontitis, run by Krishnadevaraya College of Dental Sciences & Hospital 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 6 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 17 Dec 2020. 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. 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?
Results are not available in the source record.
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?
Assessment of bacteremia using PCR (time frame: After 24 hours of collection). 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 17 Dec 2020.