Chronic PeriodontitisEarly Phase 1NCT04355416
Clinical and Anti-inflammatory Effect of Curcumin Oral Gel as Adjuncts in Treatment of Periodontal Pocket
A Early Phase 1 study testing curcumin Oral gel and subgingival scaling and root planing in people with Chronic Periodontitis, run by University of Baghdad at 1 site in Iraq.
Trial summary
application of 1% curcumin gel in clinical study design will be used . The study will be conducted in Al-Najaf specialised dentistry center. The group of patients will be consist of 25 patients, belonging to both sex, age between 30-45 years. 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?
- curcumin Oral gel and subgingival scaling and root planing
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteIraq
- Study dates
- 20 Apr 2020to 30 Jun 2020
- Phase
- Early Phase 1
- 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
- Age group of 30-45 years.
- Belonging to both sexes.
- Chronic periodontitis patients.
- Probing pocket depth (PPD) 5-7 mm.
Who cannot join
- Subjects having taken antibiotics prior to or during the trial.
- Patients on medication likely to induce gingival enlargement.
- Pregnant or lactating women.
- Smokers.
- Tobacco chewers.
- Allergy to curcumin oral gel.
- Patients with systemic disease.
Trial locations and contacts
1 site in 1 country.
Iraq1 site, 1 recruiting
- Recruiting
university of Baghdad college of dentistry
Baghdad, +964
Haider Th Farhood, B.D.S, +9647811967728, haideralhisnawi19.12.88@gmail.com
Basima Gh Ali, MSc, +9647705027397, Dr.basimaali@gmail.com
About this study
Official title: Clinical Evaluation of 1% Curcumin Oral Gel and Its Effect on the Clinical Attachment Level and the Level of IL-8 in GCF in Treatment of Periodontal Pocket
application of 1% curcumin gel in clinical study design will be used . The study will be conducted in Al-Najaf specialised dentistry center. The group of patients will be consist of 25 patients, belonging to both sex, age between 30-45 years. All patients will be diagnosed as chronic periodontitis with periodontal pockets of depth 5-7mm bilaterally to be randomly selected.
Read the detailed description
Abstract:
Background: Complete removal of irritants is not possible with mechanical therapy alone. Adjunctive use of systemic administration of antibiotics results in the distribution of drug throughout the body, which can give rise to toxicity. Curcumin (diferuloylmethane), a constituent of Curcuma longa plant, which possess antioxidant, anti-inflammatory, and anti-microbial properties. The aim of the study is to determine the effect of curcumin oral gel on the anti-inflammatory chemokines (IL_8) in the gingival crevicular fluid and to compare the effects of the curcumin gel as an adjunct to sub gingival scaling and root planing with the effect achieved using sub gingival scaling and root planing alone.
Twenty systemically healthy patients either male or female with chronic periodontitis aged between 30 and 45 years with pocket depth of 5-7 mm affecting at least two nonadjacent sites will be included. A split mouth design will be followed and the patients will receive a complete prophylaxis including scaling and root planning. In the experimental site scaling and root planing to be performed, followed by placement of the curcumin gel and periodontal pack application. In the control site, sub gingival scaling and root planning alone will be performed followed by periodontal pack application. collecting of GCF from the pocket which will be followed the same site for each visit to determine the level of IL_8 by ELISA and measurement of the clinical Parameters to be included: PLI (plaque index), BOP (bleeding on probing), PPD (probing pocket depth) and RAL (relative attachment level). These parameters will be recorded on day 0 and 30 days.
The aim of the study :
To determine the effect of curcumin oral gel on the anti inflammatory chemokines (IL_8) in the gingival crevicular fluid and to compare the effects of the curcumin gel as an adjunct to sub gingival scaling and root planning with the effect achieved using sub gingival scaling and root planing alone in the treatment of (5-7 mm) periodontal pockets on clinical Parameters: PLI (plaque index), BOP (bleeding on probing) , PPD (probing pocket depth) and RAL (relative attachment level).
Objectives:
- To evaluate the efficacy of sub gingival application of curcumin gel as an adjunct to SRP in the treatment of (5-7 mm) periodontal pockets on clinical periodontal parameter.
- To measure the concentration of IL-8 in gingival crevicular fluid before and after treatment.
Hypothesis:
Curcumin gel may have anti-inflammatory effect by reducing IL-8 and may have effect on clinical Parameters: PLI (plaque index), BOP (bleeding on probing) , PPD (probing pocket depth) and RAL (relative attachment level) in the treatment of periodontal pockets .
Alternative hypothesis:
There may be no difference in treatment of periodontal pocket by scaling and root planning and by scaling and root planning adjunct by curcumin oral gel.
Methodology:
Study design: Double blind, prospective , bio clinical research.
Setting: AL-Najaf dental specialized center.
Study design and population:
Twenty systemically healthy patients either male or female with chronic periodontitis aged between 30 and 45 years with pocket depth of 5-7 mm affecting at least two nonadjacent sites will be included. A split mouth design will be followed and the patients will receive a complete prophylaxis including scaling and root planing. Selected sites will be randomized into control and experimental sites. In the experimental site scaling and root planing to be performed, followed by placement of the curcumin gel and periodontal pack application. In the control site, sub gingival scaling and root planing alone will be performed followed by periodontal pack application. collecting of GCF from the pocket which will be followed the same site for each visit to determine the level of IL_8 by ELISA and measurement of the clinical Parameters to be included: PLI (plaque index), BOP (bleeding on probing), PPD (probing pocket depth) and RAL (relative attachment level). These parameters will be recorded on day 0 and 30 days.
Procedure/intervention:
collecting of GCF from the pocket which will be followed the same site for each visit to determine the level of IL_8 by ELISA and measuring of the clinical parameters: PLI (plaque index), BOP (bleeding on probing) , PPD (probing pocket depth) and RAL (relative attachment level) prior to the each procedure. The pocket will randomly have selected for both groups. PD will be measured with UNC 15 mm probe, acrylic stent as a guide for reproducibility from the gingival margin to base of the pocket. To achieve concealment, the patient will be blinded about intervention which side is test and which side is control. Before baseline (baseline regarded as first visit) we do oral hygiene motivation and supra gingival scaling only. At first visit (baseline ) day 0 will include collecting GCF from pocket of both side ( test and control ) to determine the level of IL_8 by ELISA and measurement of the clinical parameters : PLI (plaque index) , BOP (bleeding on probing), PPD (probing pocket depth) and RAL (relative attachment level) it also include sub gingival scaling and root planing for both side and curcumin gel will be inserted to the pocket of tested group with a 2 ml disposable syringe equipped with a blunted 25-gauge needle, which is bent along its shank after that periodontal dressing (Coe- Pak) will be used to cover the pocket on both side so as to prevent the ingress of oral fluids as well as to allow the retention of the material within the pocket. The first visit will also include oral hygiene instructions. Subjects will be recalled after 7 days, for periodontal dressing to be removed and curcumin gel will be inserted to the pocket of tested group.
The second visit (after thirty day)will include collecting GCF from the same previous site of pocket on both side to determine the level of IL_8 by ELISA and measurement of the clinical parameters : PLI (plaque index) , BOP (bleeding on probing), PPD (probing pocket depth) and RAL (relative attachment level).To ensure excellent collection of GCF, we must make sure the sites should be dried and not contaminated by saliva or blood, using cotton rolls, gentle force should be applied to avoid bleeding and the periocol strip should be inserted for 30 seconds, the sample will be transferred into eppendrof tubes and stored in -20 c until the completion of the samples collections, the tube will be allocated to the patient'code.
Assessment of the clinical parameters in the recall visit, separation of the GCF will be done by the following procedure : each sample will be micro centerfuged at 400-500g for 4-5 min then diluted by 500 microliter phosphate buffered saline and stored overnight in 4c to achieve optimal protein elusion. the periocol is then removed and the supernatants will be assayed by ELISA.
The total level of the IL_8 will be determined by using ELISA kits according to the manufacture instruction.
- Conditions
- Chronic Periodontitis
- Being tested
- curcumin Oral gel, subgingival scaling and root planing
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
curcumin Oral gelDrug
application of curcumin oral gel after scaling and root planing
subgingival scaling and root planingProcedure or surgery
subgingival scaling and root planing without application of curcumin gel
| Study group | Role | What they receive |
|---|---|---|
| curcumin oral gel | Experimental | Not described Receives: Drug: curcumin Oral gel; Procedure: subgingival scaling and root planing |
| subgingival scaling and root planing | Other | Not described Receives: Procedure: subgingival scaling and root planing |
What is being measured
The primary outcome is the main question the study is designed to answer.
measuring interleukin -8
measuring interleukin -8 in gingival crevicular fluid by using ELISA
Measured: one month
measuring plaque accumulation
measuring plaque accumulation on the teeth by measuring the plaque index using periodontal probe
Measured: one month
measuring gingival inflammation
measuring gingival inflammation by measuring the gingival index by using periodontal probe
Measured: one month
measuring periodontal pocket erosion
measuring periodontal pocket erosion and destruction by measuring bleeding on probing index using periodontal probe
Measured: one month
measuring the periodontal pocket depth
measuring the periodontal pocket depth by using periodontal pocket depth index using periodontal probe
Measured: one month
measuring periodontal attachment level
measuring periodontal attachment level by measuring clinical attachment level index using periodontal probe
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start20 Apr 2020
- Primary completion30 May 2020 (estimated)
- Study completion30 Jun 2020 (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.
- More trials run by University of BaghdadThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Twenty five systemically healthy patients either male or female with chronic periodontitis aged between 30 and 45 years with pocket depth of 5-7 mm affecting at least two nonadjacent sites will be included. A split mouth design will be followed Selected sites will be randomized into control and experimental sites. In the experimental site scaling and root planing to be performed, followed by placement of the curcumin gel and periodontal pack application. In the control site, sub gingival scaling and root planing alone will be performed followed by periodontal pack application. collecting of GCF from the pocket to determine the level of IL\_8 by ELISA and measurement of the clinical Parameters to be included: PLI (plaque index), BOP (bleeding on probing), PPD (probing pocket depth) and RAL (relative attachment level). These parameters will be recorded on day 0 and 30 days.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Collaborators
- Najaf dental specialized center
- Responsible party
- Principal investigator, Haider Thabit, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04355416
- Sponsor's protocol ID
- college of dentistry
- Status last verified
- Apr 2020
- First submitted
- 15 Apr 2020
- Last updated
- 21 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of 1% Curcumin Oral Gel and Its Effect on the Clinical Attachment Level and the Level of IL-8 in GCF in Treatment of Periodontal Pocket
- ClinicalTrials.gov ID
- NCT04355416
- Acronym / sponsor ID
- college of dentistry
- Conditions
- Chronic Periodontitis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Collaborators
- Najaf dental specialized center
- Study start
- 20 Apr 2020 (actual)
- Primary completion
- 30 May 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 21 Apr 2020 (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.
application of 1% curcumin gel in clinical study design will be used . The study will be conducted in Al-Najaf specialised dentistry center. The group of patients will be consist of 25 patients, belonging to both sex, age between 30-45 years. All patients will be diagnosed as chronic periodontitis with periodontal pockets of depth 5-7mm bilaterally to be randomly selected.
Detailed description
Abstract:
Background: Complete removal of irritants is not possible with mechanical therapy alone. Adjunctive use of systemic administration of antibiotics results in the distribution of drug throughout the body, which can give rise to toxicity. Curcumin (diferuloylmethane), a constituent of Curcuma longa plant, which possess antioxidant, anti-inflammatory, and anti-microbial properties. The aim of the study is to determine the effect of curcumin oral gel on the anti-inflammatory chemokines (IL_8) in the gingival crevicular fluid and to compare the effects of the curcumin gel as an adjunct to sub gingival scaling and root planing with the effect achieved using sub gingival scaling and root planing alone.
Twenty systemically healthy patients either male or female with chronic periodontitis aged between 30 and 45 years with pocket depth of 5-7 mm affecting at least two nonadjacent sites will be included. A split mouth design will be followed and the patients will receive a complete prophylaxis including scaling and root planning. In the experimental site scaling and root planing to be performed, followed by placement of the curcumin gel and periodontal pack application. In the control site, sub gingival scaling and root planning alone will be performed followed by periodontal pack application. collecting of GCF from the pocket which will be followed the same site for each visit to determine the level of IL_8 by ELISA and measurement of the clinical Parameters to be included: PLI (plaque index), BOP (bleeding on probing), PPD (probing pocket depth) and RAL (relative attachment level). These parameters will be recorded on day 0 and 30 days.
The aim of the study :
To determine the effect of curcumin oral gel on the anti inflammatory chemokines (IL_8) in the gingival crevicular fluid and to compare the effects of the curcumin gel as an adjunct to sub gingival scaling and root planning with the effect achieved using sub gingival scaling and root planing alone in the treatment of (5-7 mm) periodontal pockets on clinical Parameters: PLI (plaque index), BOP (bleeding on probing) , PPD (probing pocket depth) and RAL (relative attachment level).
Objectives:
- To evaluate the efficacy of sub gingival application of curcumin gel as an adjunct to SRP in the treatment of (5-7 mm) periodontal pockets on clinical periodontal parameter.
- To measure the concentration of IL-8 in gingival crevicular fluid before and after treatment.
Hypothesis:
Curcumin gel may have anti-inflammatory effect by reducing IL-8 and may have effect on clinical Parameters: PLI (plaque index), BOP (bleeding on probing) , PPD (probing pocket depth) and RAL (relative attachment level) in the treatment of periodontal pockets .
Alternative hypothesis:
There may be no difference in treatment of periodontal pocket by scaling and root planning and by scaling and root planning adjunct by curcumin oral gel.
Methodology:
Study design: Double blind, prospective , bio clinical research.
Setting: AL-Najaf dental specialized center.
Study design and population:
Twenty systemically healthy patients either male or female with chronic periodontitis aged between 30 and 45 years with pocket depth of 5-7 mm affecting at least two nonadjacent sites will be included. A split mouth design will be followed and the patients will receive a complete prophylaxis including scaling and root planing. Selected sites will be randomized into control and experimental sites. In the experimental site scaling and root planing to be performed, followed by placement of the curcumin gel and periodontal pack application. In the control site, sub gingival scaling and root planing alone will be performed followed by periodontal pack application. collecting of GCF from the pocket which will be followed the same site for each visit to determine the level of IL_8 by ELISA and measurement of the clinical Parameters to be included: PLI (plaque index), BOP (bleeding on probing), PPD (probing pocket depth) and RAL (relative attachment level). These parameters will be recorded on day 0 and 30 days.
Procedure/intervention:
collecting of GCF from the pocket which will be followed the same site for each visit to determine the level of IL_8 by ELISA and measuring of the clinical parameters: PLI (plaque index), BOP (bleeding on probing) , PPD (probing pocket depth) and RAL (relative attachment level) prior to the each procedure. The pocket will randomly have selected for both groups. PD will be measured with UNC 15 mm probe, acrylic stent as a guide for reproducibility from the gingival margin to base of the pocket. To achieve concealment, the patient will be blinded about intervention which side is test and which side is control. Before baseline (baseline regarded as first visit) we do oral hygiene motivation and supra gingival scaling only. At first visit (baseline ) day 0 will include collecting GCF from pocket of both side ( test and control ) to determine the level of IL_8 by ELISA and measurement of the clinical parameters : PLI (plaque index) , BOP (bleeding on probing), PPD (probing pocket depth) and RAL (relative attachment level) it also include sub gingival scaling and root planing for both side and curcumin gel will be inserted to the pocket of tested group with a 2 ml disposable syringe equipped with a blunted 25-gauge needle, which is bent along its shank after that periodontal dressing (Coe- Pak) will be used to cover the pocket on both side so as to prevent the ingress of oral fluids as well as to allow the retention of the material within the pocket. The first visit will also include oral hygiene instructions. Subjects will be recalled after 7 days, for periodontal dressing to be removed and curcumin gel will be inserted to the pocket of tested group.
The second visit (after thirty day)will include collecting GCF from the same previous site of pocket on both side to determine the level of IL_8 by ELISA and measurement of the clinical parameters : PLI (plaque index) , BOP (bleeding on probing), PPD (probing pocket depth) and RAL (relative attachment level).To ensure excellent collection of GCF, we must make sure the sites should be dried and not contaminated by saliva or blood, using cotton rolls, gentle force should be applied to avoid bleeding and the periocol strip should be inserted for 30 seconds, the sample will be transferred into eppendrof tubes and stored in -20 c until the completion of the samples collections, the tube will be allocated to the patient'code.
Assessment of the clinical parameters in the recall visit, separation of the GCF will be done by the following procedure : each sample will be micro centerfuged at 400-500g for 4-5 min then diluted by 500 microliter phosphate buffered saline and stored overnight in 4c to achieve optimal protein elusion. the periocol is then removed and the supernatants will be assayed by ELISA.
The total level of the IL_8 will be determined by using ELISA kits according to the manufacture instruction.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Twenty five systemically healthy patients either male or female with chronic periodontitis aged between 30 and 45 years with pocket depth of 5-7 mm affecting at least two nonadjacent sites will be included. A split mouth design will be followed Selected sites will be randomized into control and experimental sites. In the experimental site scaling and root planing to be performed, followed by placement of the curcumin gel and periodontal pack application. In the control site, sub gingival scaling and root planing alone will be performed followed by periodontal pack application. collecting of GCF from the pocket to determine the level of IL_8 by ELISA and measurement of the clinical Parameters to be included: PLI (plaque index), BOP (bleeding on probing), PPD (probing pocket depth) and RAL (relative attachment level). These parameters will be recorded on day 0 and 30 days.
| Arm | Type | Receives |
|---|---|---|
| curcumin oral gel | Experimental | Drug: curcumin Oral gel, Procedure: subgingival scaling and root planing |
| subgingival scaling and root planing | Other | Procedure: subgingival scaling and root planing |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age group of 30-45 years.
- Belonging to both sexes.
- Chronic periodontitis patients.
- Probing pocket depth (PPD) 5-7 mm.
Key exclusion criteria (7 listed)
- Subjects having taken antibiotics prior to or during the trial.
- Patients on medication likely to induce gingival enlargement.
- Pregnant or lactating women.
- Smokers.
- Tobacco chewers.
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 |
|---|---|---|
| curcumin Oral gelapplication of curcumin oral gel after scaling and root planing | Drug | curcumin oral gel |
| subgingival scaling and root planingsubgingival scaling and root planing without application of curcumin gel | Procedure or surgery | curcumin oral gel, subgingival scaling and root planing |
Primary outcome
measuring interleukin -8
Time frame: one month
measuring interleukin -8 in gingival crevicular fluid by using ELISA
measuring plaque accumulation
Time frame: one month
measuring plaque accumulation on the teeth by measuring the plaque index using periodontal probe
measuring gingival inflammation
Time frame: one month
measuring gingival inflammation by measuring the gingival index by using periodontal probe
measuring periodontal pocket erosion
Time frame: one month
measuring periodontal pocket erosion and destruction by measuring bleeding on probing index using periodontal probe
measuring the periodontal pocket depth
Time frame: one month
measuring the periodontal pocket depth by using periodontal pocket depth index using periodontal probe
measuring periodontal attachment level
Time frame: one month
measuring periodontal attachment level by measuring clinical attachment level index using periodontal probe
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2020.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing curcumin Oral gel and subgingival scaling and root planing in people with Chronic Periodontitis, run by University of Baghdad at 1 site in Iraq.
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 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 21 Apr 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 Iraq. 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Haider Th Farhood, B.D.S (+9647811967728, haideralhisnawi19.12.88@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measuring interleukin -8 (time frame: one month). The study lists 6 primary outcomes in all. 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 21 Apr 2020.