Chronic PeriodontitisPhase 1/2NCT03519152
To Compare Efficacy of Low Dose Diclofenac (25mg) in Management of Postoperative Pain After Periodontal Flap Surgery
A Phase 1/2 study testing low dose diclofenac in people with Chronic Periodontitis, run by Tatyasaheb Kore Dental College at 1 site in India.
Trial summary
Pain after periodontal surgical procedures is a common manifestation. The perception of pain is highly subjective and varies substantially among individuals. Many factors affect pain perception, such as the nature, duration, and extent of the surgery and psychological aspects (e.g., stress and anxiety). Read more about this study
- Who is it for?
- Ages 17 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- low dose diclofenac
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteIndia
- Study dates
- 20 Mar 2016to 21 May 2017
- Phase
- Phase 1/2
- 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 17 to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Generalized moderate/severe chronic periodontitis
- The probing depth (PD) of the surgical sites in the both group ranged from 5 to 8 mm.
- The clinical attachment level (CAL) at the surgical sites in both the group ranged from 5 to 9 mm.
- Quadrant with the presence of atleast 6 teeth will be selected for study.
Who cannot join
- Tobacco in any form and alcoholics.
- Pregnant and lactating mother.
- Patients with history of systemic ailments, patients under ant-inflammatory/antibiotic 3 months prior to recruitment for study.
- Subjects who had received periodontal treatment within the previous 6 months.
- Patient who have history of intolerance or hypersensitivity to Diclofenac and with gastric diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Compare Efficacy of Low Dose Diclofenac (25mg) in Management of Postoperative Pain After Periodontal Flap Surgery: A Clinical Trail.
Pain after periodontal surgical procedures is a common manifestation. The perception of pain is highly subjective and varies substantially among individuals. Many factors affect pain perception, such as the nature, duration, and extent of the surgery and psychological aspects (e.g., stress and anxiety). Pain after periodontal surgery is an example of acute dental pain of mild to moderate severity. Non-steroidal anti-inflammatory drugs (NSAIDs) have a significant advantage in the control of pain after periodontal or oral surgical procedures.
Diclofenac is a powerful anti-inflammatory and analgesic drug that is well suited for local use in the oral cavity. Diclofenac competes with arachidonic acid in a dose dependent manner for binding with platelet COX. This results in decreased production of PG and thus reduces inflammation, swelling and pain.
As Diclofenac associated with many adverse effects, like gastric irritability, nausea, headache, dizziness. Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms. As many of clinical trials have suggested Diclofeanc 50 mg alleviates the postoperative pain. So main aim of the study was to evaluate the effectiveness of low dose Diclofenac(25mg) in reducing the post operative pain after periodontal flap surgeries. Thus comparing the effects of low dose Diclofenac and Diclofenac 50mg for reducing post-operative pain.
Read the detailed description
The present split mouth, single blind randomized controlled clinical trial was carried out in the
Department of Periodontology and source of the patients was from the outpatient section of Tatyasaheb Kore Dental College \& Research Centre, New Pargaon.
Patients were enrolled in the study between November 2016 and June 2017. Based ' on the power of study that was l 80% with alpha of 0.05 with SD of ±1.47, we required
18 experimental quadrants and 18 control quadrants. Considering 10% dropout " sample size was finalized at 20.
The study included 20 patients [14 males and 6 females] with generalized chronic periodontitis.
With age ranging from 17-55 years, the selected patient had atleast 20 natural teeth, and with no history of previous periodontal therapy preceding six months of study. Medically compromised patients, pregnant and lactating mothers, smokers and alcoholics, and those with a history of taking anticoagulant therapy, patient reporting intake of steroidal or non-steroidal antiinflammatory drugs (previous 3 months) or antibiotics in previous six month were excluded from the study. Patient with known hypersensitivity to Diclofenac and gastric diseases were also not considered.
The protocol of the study was explained to each patient, and informed consent was obtained after explanation of the study. A split mouth design was used. A total of 40 quadrants in 20 patients (two quadrants in each patient) were operated. Complete medical evaluations of all the patients were done to rule out any systemic conditions.
All patients were scheduled for open flap debridement surgery on at least two quadrants >1 weeks apart. Each quadrant was randomly allocated (coin test) a different medication regimen for postoperative pain control. So in one patient two quadrant were operated one quadrant received Low Dose Diclofenac tablets (25mg Diclofenac and 325 mg paracetamol), BID for 3 days, whereas the other operated quadrant received Diclofenac (50mg Diclofenac and 325mg paracetamol), BID for 3 days.
A flap was raised under local anesthesia (2% lignocaine with 1:80,000 epinephrine). In both the quadrants same technique of anesthesia was employed. The location and the extent of surgery, volume of the local anesthesia given, and time required to perform the surgical procedure was noted in the patient file (Table/Fig 4). Participants were instructed to complete VAS chart once in the morning and once in evening for 3 days with the gap of 8 hours in between and recalled on 4thday and asked about any discomfort noted during following postoperative dayss in the form of questionnaire [Table/fig 5]. For measuring the clinical pain intensity the participants were provided with the visual analog scale (VAS). The VAS consists of a 10-cm line anchored by two extremes: no pain and pain that could not be more severe.
Participants were asked to make a mark on the line representing their level of perceived pain.
STATISTICAL ANALYSIS:- Data were analyzed using statistical software. The P value was set at 0.05 for all tests. The postsurgical pain parameters were presented as mean - SD and were compared using the independent t test.
While for the intra group analysis repeated measures of analysis of variance (ANOVA) test was used and data were presented as mean.
- Conditions
- Chronic Periodontitis
- Being tested
- low dose diclofenac
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low dose diclofenacDrug
Also called periodontal flap surgery, scaling and root planning
it is a split mouth design in which one side recieved low dose diclofenac(25mg) after periodontal flap surgery and in next week second side will recieve diclofenac 50mg after flap surgery.
| Study group | Role | What they receive |
|---|---|---|
| study group one side | Experimental | All patients were scheduled for open flap debridement surgery on at least two quadrants ≥1 weeks apart.One group will receive Low Dose Diclofenac tablets (25mg Diclofeanc and 325 mg paracetamol), BID for 3 days. The patients who are diagnosed with generalized moderate/severe chronic periodontitis will be included in study. For each quadrant, a flap was raised under local anesthesia (2% lignocaine with 1:80,000 epinephrine). In both the quadrants same technique of anesthesia will be employed. The location and the extent of surgery, volume of the local anesthesia given, and time required to perform the surgical procedure will be recorded in the patient file. Patients will be instructed to complete a pain diary chart for 3 days. Receives: Drug: low dose diclofenac |
| study group second side | Placebo comparator | Other group will receive Diclofeanc (50mg Diclofenac and 325mg paracetamol), BID for 3 days. The patients who are diagnosed with generalized moderate/severe chronic periodontitis were included in study. For each quadrant, aperiodontal flap was raised under local anesthesia (2% lignocaine with 1:80,000 epinephrine). In both the quadrants same technique of anesthesia will be employed. The location and the extent of surgery, volume of the local anesthesia given, and time required to perform the surgical procedure was recorded in the patient file. Patients were instructed to complete a pain diary chart for 3 days. Receives: Drug: low dose diclofenac |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analog scale VAS
it messures pain intensity it is an 10cm line anchored by two extremes 0 for no pain and 10 for extreme pain
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2018
- Study start20 Mar 2016
- Primary completion20 May 2017
- Study completion21 May 2017
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tatyasaheb Kore Dental College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.Kshitij .K. Karmkar, Tatyasaheb Kore Dental College
- Investigators
- Dilip Khambete, MDS, Study chair, tatayasaheb kore dental college and hospital new pargaon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03519152
- Sponsor's protocol ID
- tatyasaheb kore dental college
- Status last verified
- May 2018
- First submitted
- 1 Feb 2017
- Last updated
- 14 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Compare Efficacy of Low Dose Diclofenac (25mg) in Management of Postoperative Pain After Periodontal Flap Surgery: A Clinical Trail.
- ClinicalTrials.gov ID
- NCT03519152
- Acronym / sponsor ID
- tatyasaheb kore dental college
- Conditions
- Chronic Periodontitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Tatyasaheb Kore Dental CollegeUniversity, hospital or other
- Study start
- 20 Mar 2016 (actual)
- Primary completion
- 20 May 2017 (actual)
- Study completion
- 21 May 2017 (actual)
- First posted
- 8 May 2018 (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.
Pain after periodontal surgical procedures is a common manifestation. The perception of pain is highly subjective and varies substantially among individuals. Many factors affect pain perception, such as the nature, duration, and extent of the surgery and psychological aspects (e.g., stress and anxiety). Pain after periodontal surgery is an example of acute dental pain of mild to moderate severity. Non-steroidal anti-inflammatory drugs (NSAIDs) have a significant advantage in the control of pain after periodontal or oral surgical procedures.
Diclofenac is a powerful anti-inflammatory and analgesic drug that is well suited for local use in the oral cavity. Diclofenac competes with arachidonic acid in a dose dependent manner for binding with platelet COX. This results in decreased production of PG and thus reduces inflammation, swelling and pain.
As Diclofenac associated with many adverse effects, like gastric irritability, nausea, headache, dizziness. Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms. As many of clinical trials have suggested Diclofeanc 50 mg alleviates the postoperative pain. So main aim of the study was to evaluate the effectiveness of low dose Diclofenac(25mg) in reducing the post operative pain after periodontal flap surgeries. Thus comparing the effects of low dose Diclofenac and Diclofenac 50mg for reducing post-operative pain.
Detailed description
The present split mouth, single blind randomized controlled clinical trial was carried out in the
Department of Periodontology and source of the patients was from the outpatient section of Tatyasaheb Kore Dental College \& Research Centre, New Pargaon.
Patients were enrolled in the study between November 2016 and June 2017. Based ' on the power of study that was l 80% with alpha of 0.05 with SD of ±1.47, we required
18 experimental quadrants and 18 control quadrants. Considering 10% dropout " sample size was finalized at 20.
The study included 20 patients [14 males and 6 females] with generalized chronic periodontitis.
With age ranging from 17-55 years, the selected patient had atleast 20 natural teeth, and with no history of previous periodontal therapy preceding six months of study. Medically compromised patients, pregnant and lactating mothers, smokers and alcoholics, and those with a history of taking anticoagulant therapy, patient reporting intake of steroidal or non-steroidal antiinflammatory drugs (previous 3 months) or antibiotics in previous six month were excluded from the study. Patient with known hypersensitivity to Diclofenac and gastric diseases were also not considered.
The protocol of the study was explained to each patient, and informed consent was obtained after explanation of the study. A split mouth design was used. A total of 40 quadrants in 20 patients (two quadrants in each patient) were operated. Complete medical evaluations of all the patients were done to rule out any systemic conditions.
All patients were scheduled for open flap debridement surgery on at least two quadrants >1 weeks apart. Each quadrant was randomly allocated (coin test) a different medication regimen for postoperative pain control. So in one patient two quadrant were operated one quadrant received Low Dose Diclofenac tablets (25mg Diclofenac and 325 mg paracetamol), BID for 3 days, whereas the other operated quadrant received Diclofenac (50mg Diclofenac and 325mg paracetamol), BID for 3 days.
A flap was raised under local anesthesia (2% lignocaine with 1:80,000 epinephrine). In both the quadrants same technique of anesthesia was employed. The location and the extent of surgery, volume of the local anesthesia given, and time required to perform the surgical procedure was noted in the patient file (Table/Fig 4). Participants were instructed to complete VAS chart once in the morning and once in evening for 3 days with the gap of 8 hours in between and recalled on 4thday and asked about any discomfort noted during following postoperative dayss in the form of questionnaire [Table/fig 5]. For measuring the clinical pain intensity the participants were provided with the visual analog scale (VAS). The VAS consists of a 10-cm line anchored by two extremes: no pain and pain that could not be more severe.
Participants were asked to make a mark on the line representing their level of perceived pain.
STATISTICAL ANALYSIS:- Data were analyzed using statistical software. The P value was set at 0.05 for all tests. The postsurgical pain parameters were presented as mean - SD and were compared using the independent t test.
While for the intra group analysis repeated measures of analysis of variance (ANOVA) test was used and data were presented as mean.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group one side | Experimental | Drug: low dose diclofenacAll patients were scheduled for open flap debridement surgery on at least two quadrants ≥1 weeks apart.One group will receive Low Dose Diclofenac tablets (25mg Diclofeanc and 325 mg paracetamol), BID for 3 days. The patients who are diagnosed with generalized moderate/severe chronic periodontitis will be included in study. For each quadrant, a flap was raised under local anesthesia (2% lignocaine with 1:80,000 epinephrine). In both the quadrants same technique of anesthesia will be employed. The location and the extent of surgery, volume of the local anesthesia given, and time required to perform the surgical procedure will be recorded in the patient file. Patients will be instructed to complete a pain diary chart for 3 days. |
| study group second side | Placebo comparator | Drug: low dose diclofenacOther group will receive Diclofeanc (50mg Diclofenac and 325mg paracetamol), BID for 3 days. The patients who are diagnosed with generalized moderate/severe chronic periodontitis were included in study. For each quadrant, aperiodontal flap was raised under local anesthesia (2% lignocaine with 1:80,000 epinephrine). In both the quadrants same technique of anesthesia will be employed. The location and the extent of surgery, volume of the local anesthesia given, and time required to perform the surgical procedure was recorded in the patient file. Patients were instructed to complete a pain diary chart for 3 days. |
Who may qualify
- Ages
- 17 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Generalized moderate/severe chronic periodontitis
- The probing depth (PD) of the surgical sites in the both group ranged from 5 to 8 mm.
- The clinical attachment level (CAL) at the surgical sites in both the group ranged from 5 to 9 mm.
- Quadrant with the presence of atleast 6 teeth will be selected for study.
Key exclusion criteria (5 listed)
- Tobacco in any form and alcoholics.
- Pregnant and lactating mother.
- Patients with history of systemic ailments, patients under ant-inflammatory/antibiotic 3 months prior to recruitment for study.
- Subjects who had received periodontal treatment within the previous 6 months.
- Patient who have history of intolerance or hypersensitivity to Diclofenac and with gastric diseases
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 |
|---|---|---|
| low dose diclofenacAlso: periodontal flap surgery, scaling and root planningit is a split mouth design in which one side recieved low dose diclofenac(25mg) after periodontal flap surgery and in next week second side will recieve diclofenac 50mg after flap surgery. | Drug | study group one side, study group second side |
Primary outcome
visual analog scale VAS
Time frame: 3 days
it messures pain intensity it is an 10cm line anchored by two extremes 0 for no pain and 10 for extreme pain
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 14 May 2018.
- Individual participant dataSharing planned: No
Related trials for Chronic Periodontitis
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Effect of Cyperus Articulatus on Bacterial Reduction and Postoperative Pain
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Prevalence and Associated Factors of High BMI and Periodontitis in Thai Adults Aged Under 60 Years
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Evaluation of Masticatory Performance in Patients With Periodontitis
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Postoperative Pain and Success of Single-Visit Root Canal Treatment Using Different Root Canal Sealers in Asymptomatic Teeth
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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.
Dilip Khambete, MDS study chair
tatayasaheb kore dental college and hospital new pargaon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing low dose diclofenac in people with Chronic Periodontitis, run by Tatyasaheb Kore Dental College 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 5 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 14 May 2018. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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?
visual analog scale VAS (time frame: 3 days). 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 14 May 2018.