Chronic PeriodontitisPhase 2/3NCT03836781
Teh Effect of Subgingival Irrigation Wif Ketorolac and Chlorhexidine in Patients Wif Chronic Periodontist
A Phase 2/3 study testing Ketorolac and Chlorhexidine 2% in people with Chronic Periodontitis, run by Amirhossein Farahmand at 1 site in Iran.
Trial summary
In this study, 40 patients with a history of Mild- Periodontitis who were diagnosed with clinical and radiographic findings showed that all of the periodontal parameters before the treatment, during the treatment period Then, scaling \& Root planing and oral hygiene instructions were given to the patients, and after 2… Read more about this study
- Who is it for?
- Ages 30 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- Ketorolac and Chlorhexidine 2%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteIran
- Study dates
- 10 Apr 2018to 15 Jun 2019
- 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 30 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 40 patients with periodontitis chronic and has a 2 molar symmetrically in the lower jaw pockets of the periodontal depth of at least 5 mm and CAL 1-2 mm in at least one of the surfaces of the teeth, were selected
Who cannot join
- systemic disease
- pregnancy or breastfeeding
- allergy drug used
- smoking
- medication 6. not willing to consent to participate in the study
- 7-Trismus 8-The type of disease periodontal (Aggressive) 9. History of periodontal treatment in the previous 6 months 10-orthodontic treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Teh TEMPEffect of Subgingival Irrigation Wif Ketorolac and Chlorhexidine in Patients Wif Chronic Periodontist.
In this study, 40 patients with a history of Mild- Periodontitis who were diagnosed with clinical and radiographic findings showed that all of the periodontal parameters before the treatment, during the treatment period Then, scaling \& Root planing and oral hygiene instructions were given to the patients, and after 2 weeks, the patients who received the study were randomly divided into two groups (Balanced Block Randomization) with four blocks according to the visit time. To group A, oral chlorohexidine and to B group, the drug Ketorolac was given. 5 mm of the drugs required every 15 days the areas underwent a gingival wash with an insulin syringe, which lasted for 3 months.
Read the detailed description
In this study, 40 patients with a history of Mild- Periodontitis who were diagnosed with clinical and radiographic findings showed that all of the periodontal parameters before the treatment, during the treatment period Then, scaling \& Root planing and oral hygiene instructions were given to the patients, and after 2 weeks, the patients who received the study were randomly divided into two groups (Balanced Block Randomization) with four blocks according to the visit time. To group A, oral chlorohexidine (Ghol Darou-Tehran) and to B group, the drug Ketorolac (Exir-Boroujerd) was given. 5 mm of the drugs required every 15 days the areas underwent a gingival wash with an insulin syringe, which lasted for 3 months. Pl, BI, PD were evaluated in the study sessions. At the end of the clinical change, a multiple measure ANOVA test was used to compare the preceding and follow-up sessions in both groups, considering the intervention method as Between subject comparison And measured at the time of measurement as a Repeated Factor.
- Conditions
- Chronic Periodontitis
- Being tested
- Ketorolac, Chlorhexidine 2%
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetorolacDrug
Also called Group A
Ketorolac 3% topical subgingival irrigation was put into the periodontal pocket using an insulin syringe
Chlorhexidine 2%Drug
Also called Group B
Chlorhexidine 2% topical subgingival irrigation was put into the periodontal pocket using an insulin syringe
| Study group | Role | What they receive |
|---|---|---|
| ketorolac 3% | Active comparator | ketorolac 3% topical subgingival irrigation was put into the periodontal pocket using an insulin syringe Receives: Drug: Ketorolac |
| chlorhexidine 2% | Other | chlorhexidine 2% topical subgingival irrigation was put into the periodontal pocket using an insulin syringe Receives: Drug: Chlorhexidine 2% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pocket depth
Clinical periodontal measurements to Williams periodontal probe
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2019
- Study start10 Apr 2018
- Primary completion8 Jun 2019
- Study completion15 Jun 2019
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- split mouth
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amirhossein Farahmand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Amirhossein Farahmand, Islamic Azad University, Sanandaj
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03836781
- Sponsor's protocol ID
- 2037
- Status last verified
- Jul 2019
- First submitted
- 8 Feb 2019
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Teh TEMPEffect of Subgingival Irrigation Wif Ketorolac and Chlorhexidine in Patients Wif Chronic Periodontist.
- ClinicalTrials.gov ID
- NCT03836781
- Acronym / sponsor ID
- 2037
- Conditions
- Chronic Periodontitis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Amirhossein FarahmandUniversity, hospital or other
- Study start
- 10 Apr 2018 (actual)
- Primary completion
- 8 Jun 2019 (actual)
- Study completion
- 15 Jun 2019 (actual)
- First posted
- 11 Feb 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.
In this study, 40 patients with a history of Mild- Periodontitis who were diagnosed with clinical and radiographic findings showed that all of the periodontal parameters before the treatment, during the treatment period Then, scaling \& Root planing and oral hygiene instructions were given to the patients, and after 2 weeks, the patients who received the study were randomly divided into two groups (Balanced Block Randomization) with four blocks according to the visit time. To group A, oral chlorohexidine and to B group, the drug Ketorolac was given. 5 mm of the drugs required every 15 days the areas underwent a gingival wash with an insulin syringe, which lasted for 3 months.
Detailed description
In this study, 40 patients with a history of Mild- Periodontitis who were diagnosed with clinical and radiographic findings showed that all of the periodontal parameters before the treatment, during the treatment period Then, scaling \& Root planing and oral hygiene instructions were given to the patients, and after 2 weeks, the patients who received the study were randomly divided into two groups (Balanced Block Randomization) with four blocks according to the visit time. To group A, oral chlorohexidine (Ghol Darou-Tehran) and to B group, the drug Ketorolac (Exir-Boroujerd) was given. 5 mm of the drugs required every 15 days the areas underwent a gingival wash with an insulin syringe, which lasted for 3 months. Pl, BI, PD were evaluated in the study sessions. At the end of the clinical change, a multiple measure ANOVA test was used to compare the preceding and follow-up sessions in both groups, considering the intervention method as Between subject comparison And measured at the time of measurement as a Repeated Factor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- split mouth
| Arm | Type | Receives |
|---|---|---|
| ketorolac 3% | Active comparator | Drug: Ketorolacketorolac 3% topical subgingival irrigation was put into the periodontal pocket using an insulin syringe |
| chlorhexidine 2% | Other | Drug: Chlorhexidine 2%chlorhexidine 2% topical subgingival irrigation was put into the periodontal pocket using an insulin syringe |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 40 patients with periodontitis chronic and has a 2 molar symmetrically in the lower jaw pockets of the periodontal depth of at least 5 mm and CAL 1-2 mm in at least one of the surfaces of the teeth, were selected
Key exclusion criteria (6 listed)
- systemic disease
- pregnancy or breastfeeding
- allergy drug used
- smoking
- medication 6. not willing to consent to participate in the 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 |
|---|---|---|
| KetorolacAlso: Group AKetorolac 3% topical subgingival irrigation was put into the periodontal pocket using an insulin syringe | Drug | ketorolac 3% |
| Chlorhexidine 2%Also: Group BChlorhexidine 2% topical subgingival irrigation was put into the periodontal pocket using an insulin syringe | Drug | chlorhexidine 2% |
Primary outcome
Pocket depth
Time frame: 3 month
Clinical periodontal measurements to Williams periodontal probe
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 5 Jul 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ketorolac and Chlorhexidine 2% in people with Chronic Periodontitis, run by Amirhossein Farahmand at 1 site in Iran.
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 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: finished, as of the sponsor's last update on 5 Jul 2019. 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 Iran. 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.
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?
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?
Pocket depth (time frame: 3 month). 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 Jul 2019.