Periodontal DiseasesNCT06604013
Gingival Crevicular Fluid of Adiponectin and Resistin As Predictable Implement in Staging and Grading System of Periodontitis
A study testing non-surgical full-mouth periodontal therapy without using adjunct disinfectants and GCF level of adiponectin and resistin in people with Periodontal Diseases and Obesity, Morbid, run by Al-Azhar University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to evaluate the relationship between obesity and gingival crevicular fluid resistin and adiponectin in periodontitis patients as well as assess the effect of non-surgical periodontal therapy on their levels using ELISA in obese individuals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontal Diseases, Obesity, Morbid
- What is being tested?
- non-surgical full-mouth periodontal therapy without using adjunct disinfectants and GCF level of adiponectin and resistin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Sep 2023to 29 Aug 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- obese persons with Body Mass Index (BMI) more than 40 and suffering from periodontitis
Who cannot join
- Patients receiving either antibiotics or non-steroidal anti- inflammatory at least 3 months prior to samples collection.
- Patients subjected to previous periodontal therapy 6 months before sampling. Patients with systemic or local inflammatory conditions other than periodontal disease.
- Neither lactating nor pregnant.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dental Medicine, Al-Azhar University Assiut Branch
Asyut, Asyut Governorate, 71524
About this study
Official title: Class III Obesity and Periodontitis: Gingival Crevicular Fluid of Adiponectin and Resistin As Predictable Implement in Staging and Grading System and Effects of Periodontal Therapy
The goal of this clinical trial is to evaluate the relationship between obesity and gingival crevicular fluid resistin and adiponectin in periodontitis patients as well as assess the effect of non-surgical periodontal therapy on their levels using ELISA in obese individuals. Researchers will compare different stages of periodontitis to see if degrees of inflammation and periodontal therapy related obesity
- Conditions
- Periodontal Diseases, Obesity, Morbid
- Being tested
- non-surgical full-mouth periodontal therapy without using adjunct disinfectants, GCF level of adiponectin and resistin
- Keywords
- resistin, adiponectin, periodontitis Grading, periodontal therapy
- Medical subject headings
- Periodontal Diseases, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-surgical full-mouth periodontal therapy without using adjunct disinfectantsProcedure or surgery
Supragingival scaling was performed by Ultrasonic Scaler and manual scaling by sickle scaler . Subgingival scaling and root planing were accomplished with either universal or area specific Gracey curettes
GCF level of adiponectin and resistinDiagnostic test
Gingival crevicular fluid (GCF) samples were gathered and relocated in phosphate buffer saline inside Eppendorf tube then t they were manipulated by commercially available enzyme-linked immuno-sorbent assay
| Study group | Role | What they receive |
|---|---|---|
| mild periodontitis (first stage, grade B) | Active comparator | mild periodontitis (first stage, grade B) manifesting CAL ≥ 1-2 mm, in corporation with percentage of bone loss level divided by age was 0.25-1% very year. patients received non-surgical full-mouth periodontal therapy without using adjunct disinfectants. Receives: Procedure: non-surgical full-mouth periodontal therapy without using adjunct disinfectants; Diagnostic Test: GCF level of adiponectin and resistin |
| moderate periodontitis (second stage, grade B) | Active comparator | moderate periodontitis (second stage, grade B) manifesting CAL ≥ 3-4mm in corporation with percentage of bone loss level divided by age was 0.25-1% very year. patients received non-surgical full-mouth periodontal therapy without using adjunct disinfectants. Receives: Procedure: non-surgical full-mouth periodontal therapy without using adjunct disinfectants; Diagnostic Test: GCF level of adiponectin and resistin |
| severe periodontitis (third stage, grade B) | Active comparator | severe periodontitis (third stage, grade B) manifesting CAL ≥ 5mm , in corporation with BoP increased than (30%), percentage of bone loss level divided by age was 0.25-1% very year. patients received non-surgical full-mouth periodontal therapy without using adjunct disinfectants Receives: Procedure: non-surgical full-mouth periodontal therapy without using adjunct disinfectants; Diagnostic Test: GCF level of adiponectin and resistin |
| very severe periodontitis (forth stage, grade C) | Active comparator | very severe periodontitis (forth stage, grade C) manifesting CAL ≥ 5mm in corporation of percentage of bone loss level divided by age more than 1% very year. patients received non-surgical full-mouth periodontal therapy without using adjunct disinfectants Receives: Procedure: non-surgical full-mouth periodontal therapy without using adjunct disinfectants; Diagnostic Test: GCF level of adiponectin and resistin |
What is being measured
The primary outcome is the main question the study is designed to answer.
adiponectin level in gingival crevicular fluid
Measured: From enrollment to the end of treatment results assessment at 12 weeks
resistin level in gingival crevicular fluid
Measured: From enrollment to the end of treatment results assessment at 12 weeks
Secondary outcomes (4)
O'Leary Plaque score
Measured: From enrollment to the end of treatment results assessment at 12 weeks
bleeding on probing percentage (BoP)
Measured: From enrollment to the end of treatment results assessment at 12 weeks
clinical attachment level (CAL)
Measured: From enrollment to the end of treatment results assessment at 12 weeks
probing pocket depth
Measured: From enrollment to the end of treatment results assessment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start10 Sep 2023
- Primary completion23 Apr 2024
- Study completion29 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe 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
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asem Mohammed Kamel Ali, Al-Azhar University
- Investigators
- Bahaa Mohammed Badr, associate professor, Study director, Faculty of dental medicine Al-Azhar university Assiut BranchAsem Mohammed kamel, lecturer, Study director, Faculty of dental medicine Al-Azhar university Assiut Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06604013
- Sponsor's protocol ID
- Obesity and Periodontitis
- Status last verified
- Sep 2024
- First submitted
- 16 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Kusminski CM, McTernan PG, Kumar S. Role of resistin in obesity, insulin resistance and Type II diabetes. Clin Sci (Lond). 2005 Sep;109(3):243-56. doi: 10.1042/CS20050078.
PubMed 16104844Filkova M, Haluzik M, Gay S, Senolt L. The role of resistin as a regulator of inflammation: Implications for various human pathologies. Clin Immunol. 2009 Nov;133(2):157-70. doi: 10.1016/j.clim.2009.07.013. Epub 2009 Sep 8.
PubMed 19740705Cugini MA, Haffajee AD, Smith C, Kent RL Jr, Socransky SS. The effect of scaling and root planing on the clinical and microbiological parameters of periodontal diseases: 12-month results. J Clin Periodontol. 2000 Jan;27(1):30-6. doi: 10.1034/j.1600-051x.2000.027001030.x.
PubMed 10674959
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Class III Obesity and Periodontitis: Gingival Crevicular Fluid of Adiponectin and Resistin As Predictable Implement in Staging and Grading System and Effects of Periodontal Therapy
- ClinicalTrials.gov ID
- NCT06604013
- Acronym / sponsor ID
- Obesity and Periodontitis
- Conditions
- Periodontal Diseases, Obesity, Morbid
- Keywords
- resistin, adiponectin, periodontitis Grading, periodontal therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 10 Sep 2023 (actual)
- Primary completion
- 23 Apr 2024 (actual)
- Study completion
- 29 Aug 2024 (actual)
- First posted
- 19 Sep 2024 (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 goal of this clinical trial is to evaluate the relationship between obesity and gingival crevicular fluid resistin and adiponectin in periodontitis patients as well as assess the effect of non-surgical periodontal therapy on their levels using ELISA in obese individuals. Researchers will compare different stages of periodontitis to see if degrees of inflammation and periodontal therapy related obesity
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| mild periodontitis (first stage, grade B) | Active comparator | Procedure: non-surgical full-mouth periodontal therapy without using adjunct disinfectants, Diagnostic Test: GCF level of adiponectin and resistinmild periodontitis (first stage, grade B) manifesting CAL ≥ 1-2 mm, in corporation with percentage of bone loss level divided by age was 0.25-1% very year. patients received non-surgical full-mouth periodontal therapy without using adjunct disinfectants. |
| moderate periodontitis (second stage, grade B) | Active comparator | Procedure: non-surgical full-mouth periodontal therapy without using adjunct disinfectants, Diagnostic Test: GCF level of adiponectin and resistinmoderate periodontitis (second stage, grade B) manifesting CAL ≥ 3-4mm in corporation with percentage of bone loss level divided by age was 0.25-1% very year. patients received non-surgical full-mouth periodontal therapy without using adjunct disinfectants. |
| severe periodontitis (third stage, grade B) | Active comparator | Procedure: non-surgical full-mouth periodontal therapy without using adjunct disinfectants, Diagnostic Test: GCF level of adiponectin and resistinsevere periodontitis (third stage, grade B) manifesting CAL ≥ 5mm , in corporation with BoP increased than (30%), percentage of bone loss level divided by age was 0.25-1% very year. patients received non-surgical full-mouth periodontal therapy without using adjunct disinfectants |
| very severe periodontitis (forth stage, grade C) | Active comparator | Procedure: non-surgical full-mouth periodontal therapy without using adjunct disinfectants, Diagnostic Test: GCF level of adiponectin and resistinvery severe periodontitis (forth stage, grade C) manifesting CAL ≥ 5mm in corporation of percentage of bone loss level divided by age more than 1% very year. patients received non-surgical full-mouth periodontal therapy without using adjunct disinfectants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- obese persons with Body Mass Index (BMI) more than 40 and suffering from periodontitis
Key exclusion criteria (3 listed)
- Patients receiving either antibiotics or non-steroidal anti- inflammatory at least 3 months prior to samples collection.
- Patients subjected to previous periodontal therapy 6 months before sampling. Patients with systemic or local inflammatory conditions other than periodontal disease.
- Neither lactating nor pregnant.
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 |
|---|---|---|
| non-surgical full-mouth periodontal therapy without using adjunct disinfectantsSupragingival scaling was performed by Ultrasonic Scaler and manual scaling by sickle scaler . Subgingival scaling and root planing were accomplished with either universal or area specific Gracey curettes | Procedure or surgery | mild periodontitis (first stage, grade B), moderate periodontitis (second stage, grade B), severe periodontitis (third stage, grade B), very severe periodontitis (forth stage, grade C) |
| GCF level of adiponectin and resistinGingival crevicular fluid (GCF) samples were gathered and relocated in phosphate buffer saline inside Eppendorf tube then t they were manipulated by commercially available enzyme-linked immuno-sorbent assay | Diagnostic test | mild periodontitis (first stage, grade B), moderate periodontitis (second stage, grade B), severe periodontitis (third stage, grade B), very severe periodontitis (forth stage, grade C) |
Primary outcome
adiponectin level in gingival crevicular fluid
Time frame: From enrollment to the end of treatment results assessment at 12 weeks
resistin level in gingival crevicular fluid
Time frame: From enrollment to the end of treatment results assessment at 12 weeks
4 secondary outcomes
O'Leary Plaque score
Time frame: From enrollment to the end of treatment results assessment at 12 weeks
bleeding on probing percentage (BoP)
Time frame: From enrollment to the end of treatment results assessment at 12 weeks
clinical attachment level (CAL)
Time frame: From enrollment to the end of treatment results assessment at 12 weeks
probing pocket depth
Time frame: From enrollment to the end of treatment results assessment at 12 weeks
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 19 Sep 2024.
- Background: PubMed 16104844Kusminski CM, McTernan PG, Kumar S. Role of resistin in obesity, insulin resistance and Type II diabetes. Clin Sci (Lond). 2005 Sep;109(3):243-56. doi: 10.1042/CS20050078.
- Background: PubMed 19740705Filkova M, Haluzik M, Gay S, Senolt L. The role of resistin as a regulator of inflammation: Implications for various human pathologies. Clin Immunol. 2009 Nov;133(2):157-70. doi: 10.1016/j.clim.2009.07.013. Epub 2009 Sep 8.
- Background: PubMed 10674959Cugini MA, Haffajee AD, Smith C, Kent RL Jr, Socransky SS. The effect of scaling and root planing on the clinical and microbiological parameters of periodontal diseases: 12-month results. J Clin Periodontol. 2000 Jan;27(1):30-6. doi: 10.1034/j.1600-051x.2000.027001030.x.
- 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.
Bahaa Mohammed Badr, associate professor study director
Faculty of dental medicine Al-Azhar university Assiut Branch
Asem Mohammed kamel, lecturer study director
Faculty of dental medicine Al-Azhar university Assiut Branch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non-surgical full-mouth periodontal therapy without using adjunct disinfectants and GCF level of adiponectin and resistin in people with Periodontal Diseases and Obesity, Morbid, run by Al-Azhar University at 1 site in Egypt.
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 3 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 19 Sep 2024. 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 Egypt. 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?
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?
adiponectin level in gingival crevicular fluid (time frame: From enrollment to the end of treatment results assessment at 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06604013, which also lists 3 linked publications.
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 19 Sep 2024.