ObesityNCT02508987
Obesity and Oxidative Stress in Patients With Different Periodontal Status
An observational study of Obesity and Periodontitis, run by Ondokuz Mayıs University.
Trial summary
The aim of the study is to evaluate the effect of obesity on periodontally healthy or diseased tissues.Normal weight and obese subjects were analyzed in 6 groups. Clinical periodontal status was determined through plaque index, gingival index, bleeding on probing, pocket probing depth, clinical attacment level and… Read more about this study
- Who is it for?
- Ages 35 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Periodontitis, Gingivitis
- How many people
- 93 participants
- Where
- No sites listed yet
- Study dates
- Sep 2012to Mar 2014
- Phase
- Observational
- 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 35 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Systemically healthy 45 normal weight adults and 48 class I obese adults
Who may be able to join
- ≥ 18 years of age and having ≥ 16 teeth; (ii) no periodontal therapy in the 6 months prior to data collection; (iii) no systemic problems or chemotherapy within the 6 weeks prior to data collection; (iv) no previous history of smoking.
Who cannot join
- medical history of cancer, rheumatoid arthritis, diabetes mellitus, or cardiovascular disease; (ii) compromised immune system; (iii) pregnancy, menopause, or lactation; (iv) ongoing drug therapy that might affect the clinical characteristics of periodontitis; (v) use of systemic antimicrobials during the 6 weeks prior to data collection; (vi) dental treatment during the 6 months prior to data collection.
About this study
Official title: Obesity and Oxidative Stress in Patients With Different Periodontal Status: A Cross-sectional Study
The aim of the study is to evaluate the effect of obesity on periodontally healthy or diseased tissues.Normal weight and obese subjects were analyzed in 6 groups. Clinical periodontal status was determined through plaque index, gingival index, bleeding on probing, pocket probing depth, clinical attacment level and radiographs.
Oxidative stress is known to contribute to various diseases by affecting cellular functions through the oxidation of proteins, lipids and DNA. Oxidative stress can be assessed by measuring the products of oxidative damage found in proteins, lipids and DNA or reductions in total antioxidant capacity Malondialdehyde, protein carbonyl and total antioxidant capacity levels are biomarkers of oxidative stress in gingival crevicular fluid.
Read the detailed description
This cross-sectional study was conducted with 93 subjects (45 normal-weight, and 48 class I obese) recruited from the Periodontology Department at the Ondokuz Mayıs University Faculty of Dentistry; Endocrinology and Metabolic Diseases Department at the Ondokuz Mayıs University Faculty of Medicine in Turkey, between September 2012 and March 2014.
The study protocol was approved by the Local Ethics Committee, and written informed consent was obtained from all study participants in accordance with the Helsinki Declaration (revised in 2000).
Oxidative stress occurs when the balance between reactive oxygen species and antioxidants become unbalanced. OS can be determined by evaluation of oxidative damage products in proteins, lipids and DNA or the reduction of total antioxidant capacity.
Malondialdehyde level is the biomarker of oxidative stress in lipids. Protein carbonyl level is the biomarker of oxidative stress in proteins.Total antioxidant capacity level is another biomarker of oxidative stress. Malondialdehyde, protein carbonyl and total antioxidant levels in crevicular fluid were examined by ELISA method.
Obesity was diagnosed according to World Health Organization criteria using body mass index. Body mass index is defined as a person's weight, in kilograms (kg), divided by the square of height in meters (m), and it is classified as follows:
≤18.49 kg/m2: Under-weight 18.50-24.99 kg/m2: Normal-weight 25.00-29.99 kg/m2: Overweight 30.00-34.9 kg/m2: Obesity class I 35.00-39.99 kg/m2: Obesity class II
≥40.00 kg/m2: Obesity class III (morbid obesity)
Periodontal status was determined through plaque index, gingival index, bleeding on probing, pocket probing depth, clinical attachment level and radiographs. Periodontal status was classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions as either 'periodontally healthy', 'gingivitis' or 'generalized chronic periodontitis'. Study participants were then grouped according to body mass index and periodontal status as follows:
Group 1: Group normal weight +periodontally healthy subjects Group 2: Group normal weight + gingivitis subjects Group 3: Group normal weight + generalized chronic periodontitis subjects Group 4: Group obese + periodontally healthy subjects Group 5: Group obese + gingivitis subjects Group 6: Group obese + generalized chronic periodontitis subjects All clinical examinations and gingival crevicular fluid collection were performed by a single examiner. All laboratory procedures were performed by another researcher blinded to the study.
A total of 108 gingival crevicular fluid samples were taken from the Group 5 (18 subjects x 6 sites) and 90 samples from each of the remaining 5 groups (15 subjects per group x 6 sites). All samples were collected between 8-10 am on the day following periodontal status assessment. Samples were collected from the sites in the chronic periodontitis group that fit the following criteria: pocket probing depth≥5mm, clinical attachment level≥5mm and ≥30% radiographic alveolar bone loss. Accordingly, gingival crevicular fluid samples were collected from 2 molar teeth, 2 premolar teeth and 2 incisors. Gingival crevicular fluid samples were collected from the same 6 sites in the gingivitis and periodontally healthy groups in order to maintain consistency of sampling.
- Conditions
- Obesity, Periodontitis, Gingivitis
- Keywords
- Obesity, oxidative stress, antioxidants, periodontal disease
- Medical subject headings
- Obesity, Periodontitis, Gingivitis, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions as periodontally healthy.Periodontal status was determined by evaluating the following clinical parameters: Silness \& Löe plaque index; Löe \& Silness gingival index; probing pocket depth; clinical attachment level; bleeding on probing. Obesity was diagnosed according to World Health Organization criteria using body mass index. 18.50-24.99 kg/m2: Normal-weight | |
| Group 2 | Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions as gingivitis. Periodontal status was determined by evaluating the following clinical parameters: Silness \& Löe plaque index; Löe \& Silness gingival index; probing pocket depth; clinical attachment level; bleeding on probing. Obesity was diagnosed according to World Health Organization criteria using body mass index. 18.50-24.99 kg/m2: Normal-weight | |
| Group 3 | Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions as 'generalized chronic periodontitis'. Periodontal status was determined by evaluating the following clinical parameters: Silness \& Löe plaque index; Löe \& Silness gingival index; probing pocket depth; clinical attachment level; bleeding on probing. Obesity was diagnosed according to World Health Organization criteria using body mass index.18.50-24.99 kg/m2: Normal-weight | |
| Group 4 | Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions as either 'periodontally healthy'. Periodontal status was determined by evaluating the following clinical parameters: Silness \& Löe plaque index; Löe \& Silness gingival index; probing pocket depth; clinical attachment level; bleeding on probing. Obesity was diagnosed according to World Health Organization criteria using body mass index. 30.00-34.9 kg/m2: Obesity class I | |
| Group 5 | Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions as 'gingivitis'. Periodontal status was determined by evaluating the following clinical parameters: Silness \& Löe plaque index; Löe \& Silness gingival index; probing pocket depth; clinical attachment level; bleeding on probing. Obesity was diagnosed according to World Health Organization criteria using body mass index. 30.00-34.9 kg/m2: Obesity class I | |
| Group 6 | Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions as 'generalized chronic periodontitis'. Periodontal status was determined by evaluating the following clinical parameters: Silness \& Löe plaque index; Löe \& Silness gingival index; probing pocket depth; clinical attachment level; bleeding on probing. Obesity was diagnosed according to World Health Organization criteria using body mass index. 30.00-34.9 kg/m2: Obesity class I |
What is being measured
The primary outcome is the main question the study is designed to answer.
Malondialdehyde levels in gingival crevicular fluid as measured an oxidative stress marker in lipids
Malondialdehyde is the most specific and most used molecule for measurement of biological lipid oxidation.
Measured: between 8-10 am on the day following periodontal status assessment.
Protein Carbonyl levels in gingival crevicular fluid as measured an oxidative stress marker in proteins
Protein carbonyl is another biomarker of oxidative stress
Measured: between 8-10 am on the day following periodontal status assessment.
Reduction of total antioxidant capacity levels in gingival crevicular fluid as measured an oxidative stress marker
Total antioxidant capacity provides an overview of the biological interaction between an individuals' antioxidant status and how well these antioxidants are able to protect host cells during periods of oxidative stress. Due to the potential synergistic effects of different antioxidant molecules, the measurement of total antioxidant capacity can provide a more accurate assessment of antioxidant status than the separate measurement of individual molecules.
Measured: between 8-10 am on the day following periodontal status assessment.
Secondary outcomes (5)
Plaque index
Measured: the day before gingival crevicular fluid samples were collected
Gingival index
Measured: the day before gingival crevicular fluid samples were collected
Bleeding on probing
Measured: the day before gingival crevicular fluid samples were collected
Pocket probing depth
Measured: the day before gingival crevicular fluid samples were collected
Clinical attachment level
Measured: the day before gingival crevicular fluid samples were collected
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2015 (estimated)
- Study startSep 2012
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs 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
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vadim Ekrem Atabay, Ondokuz Mayıs University
- Investigators
- Vadim E Atabay, phd, Principal investigator, research assistant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02508987
- Sponsor's protocol ID
- PYO.DIS.1904.13.002
- Status last verified
- Jul 2015
- First submitted
- 22 Jul 2015
- Last updated
- 27 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Obesity: preventing and managing the global epidemic. Report of a WHO consultation. World Health Organ Tech Rep Ser. 2000;894:i-xii, 1-253.
PubMed 11234459Armitage GC. Development of a classification system for periodontal diseases and conditions. Ann Periodontol. 1999 Dec;4(1):1-6. doi: 10.1902/annals.1999.4.1.1.
PubMed 10863370LOE H, SILNESS J. PERIODONTAL DISEASE IN PREGNANCY. I. PREVALENCE AND SEVERITY. Acta Odontol Scand. 1963 Dec;21:533-51. doi: 10.3109/00016356309011240. No abstract available.
PubMed 14121956SILNESS J, LOE H. PERIODONTAL DISEASE IN PREGNANCY. II. CORRELATION BETWEEN ORAL HYGIENE AND PERIODONTAL CONDTION. Acta Odontol Scand. 1964 Feb;22:121-35. doi: 10.3109/00016356408993968. No abstract available.
PubMed 14158464
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obesity and Oxidative Stress in Patients With Different Periodontal Status: A Cross-sectional Study
- ClinicalTrials.gov ID
- NCT02508987
- Acronym / sponsor ID
- PYO.DIS.1904.13.002
- Conditions
- Obesity, Periodontitis, Gingivitis
- Keywords
- Obesity, oxidative stress, antioxidants, periodontal disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 27 Jul 2015 (estimated)
- 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 aim of the study is to evaluate the effect of obesity on periodontally healthy or diseased tissues.Normal weight and obese subjects were analyzed in 6 groups. Clinical periodontal status was determined through plaque index, gingival index, bleeding on probing, pocket probing depth, clinical attacment level and radiographs.
Oxidative stress is known to contribute to various diseases by affecting cellular functions through the oxidation of proteins, lipids and DNA. Oxidative stress can be assessed by measuring the products of oxidative damage found in proteins, lipids and DNA or reductions in total antioxidant capacity Malondialdehyde, protein carbonyl and total antioxidant capacity levels are biomarkers of oxidative stress in gingival crevicular fluid.
Detailed description
This cross-sectional study was conducted with 93 subjects (45 normal-weight, and 48 class I obese) recruited from the Periodontology Department at the Ondokuz Mayıs University Faculty of Dentistry; Endocrinology and Metabolic Diseases Department at the Ondokuz Mayıs University Faculty of Medicine in Turkey, between September 2012 and March 2014.
The study protocol was approved by the Local Ethics Committee, and written informed consent was obtained from all study participants in accordance with the Helsinki Declaration (revised in 2000).
Oxidative stress occurs when the balance between reactive oxygen species and antioxidants become unbalanced. OS can be determined by evaluation of oxidative damage products in proteins, lipids and DNA or the reduction of total antioxidant capacity.
Malondialdehyde level is the biomarker of oxidative stress in lipids. Protein carbonyl level is the biomarker of oxidative stress in proteins.Total antioxidant capacity level is another biomarker of oxidative stress. Malondialdehyde, protein carbonyl and total antioxidant levels in crevicular fluid were examined by ELISA method.
Obesity was diagnosed according to World Health Organization criteria using body mass index. Body mass index is defined as a person's weight, in kilograms (kg), divided by the square of height in meters (m), and it is classified as follows:
≤18.49 kg/m2: Under-weight 18.50-24.99 kg/m2: Normal-weight 25.00-29.99 kg/m2: Overweight 30.00-34.9 kg/m2: Obesity class I 35.00-39.99 kg/m2: Obesity class II
≥40.00 kg/m2: Obesity class III (morbid obesity)
Periodontal status was determined through plaque index, gingival index, bleeding on probing, pocket probing depth, clinical attachment level and radiographs. Periodontal status was classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions as either 'periodontally healthy', 'gingivitis' or 'generalized chronic periodontitis'. Study participants were then grouped according to body mass index and periodontal status as follows:
Group 1: Group normal weight +periodontally healthy subjects Group 2: Group normal weight + gingivitis subjects Group 3: Group normal weight + generalized chronic periodontitis subjects Group 4: Group obese + periodontally healthy subjects Group 5: Group obese + gingivitis subjects Group 6: Group obese + generalized chronic periodontitis subjects All clinical examinations and gingival crevicular fluid collection were performed by a single examiner. All laboratory procedures were performed by another researcher blinded to the study.
A total of 108 gingival crevicular fluid samples were taken from the Group 5 (18 subjects x 6 sites) and 90 samples from each of the remaining 5 groups (15 subjects per group x 6 sites). All samples were collected between 8-10 am on the day following periodontal status assessment. Samples were collected from the sites in the chronic periodontitis group that fit the following criteria: pocket probing depth≥5mm, clinical attachment level≥5mm and ≥30% radiographic alveolar bone loss. Accordingly, gingival crevicular fluid samples were collected from 2 molar teeth, 2 premolar teeth and 2 incisors. Gingival crevicular fluid samples were collected from the same 6 sites in the gingivitis and periodontally healthy groups in order to maintain consistency of sampling.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions as periodontally healthy.Periodontal status was determined by evaluating the following clinical parameters: Silness \& Löe plaque index; Löe \& Silness gingival index; probing pocket depth; clinical attachment level; bleeding on probing. Obesity was diagnosed according to World Health Organization criteria using body mass index. 18.50-24.99 kg/m2: Normal-weight |
| Group 2 | – | –Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions as gingivitis. Periodontal status was determined by evaluating the following clinical parameters: Silness \& Löe plaque index; Löe \& Silness gingival index; probing pocket depth; clinical attachment level; bleeding on probing. Obesity was diagnosed according to World Health Organization criteria using body mass index. 18.50-24.99 kg/m2: Normal-weight |
| Group 3 | – | –Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions as 'generalized chronic periodontitis'. Periodontal status was determined by evaluating the following clinical parameters: Silness \& Löe plaque index; Löe \& Silness gingival index; probing pocket depth; clinical attachment level; bleeding on probing. Obesity was diagnosed according to World Health Organization criteria using body mass index.18.50-24.99 kg/m2: Normal-weight |
| Group 4 | – | –Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions as either 'periodontally healthy'. Periodontal status was determined by evaluating the following clinical parameters: Silness \& Löe plaque index; Löe \& Silness gingival index; probing pocket depth; clinical attachment level; bleeding on probing. Obesity was diagnosed according to World Health Organization criteria using body mass index. 30.00-34.9 kg/m2: Obesity class I |
| Group 5 | – | –Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions as 'gingivitis'. Periodontal status was determined by evaluating the following clinical parameters: Silness \& Löe plaque index; Löe \& Silness gingival index; probing pocket depth; clinical attachment level; bleeding on probing. Obesity was diagnosed according to World Health Organization criteria using body mass index. 30.00-34.9 kg/m2: Obesity class I |
| Group 6 | – | –Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions as 'generalized chronic periodontitis'. Periodontal status was determined by evaluating the following clinical parameters: Silness \& Löe plaque index; Löe \& Silness gingival index; probing pocket depth; clinical attachment level; bleeding on probing. Obesity was diagnosed according to World Health Organization criteria using body mass index. 30.00-34.9 kg/m2: Obesity class I |
Who may qualify
- Ages
- 35 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Systemically healthy 45 normal weight adults and 48 class I obese adults
Key inclusion criteria (1 listed)
- ≥ 18 years of age and having ≥ 16 teeth; (ii) no periodontal therapy in the 6 months prior to data collection; (iii) no systemic problems or chemotherapy within the 6 weeks prior to data collection; (iv) no previous history of smoking.
Key exclusion criteria (1 listed)
- medical history of cancer, rheumatoid arthritis, diabetes mellitus, or cardiovascular disease; (ii) compromised immune system; (iii) pregnancy, menopause, or lactation; (iv) ongoing drug therapy that might affect the clinical characteristics of periodontitis; (v) use of systemic antimicrobials during the 6 weeks prior to data collection; (vi) dental treatment during the 6 months prior to data collection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Malondialdehyde levels in gingival crevicular fluid as measured an oxidative stress marker in lipids
Time frame: between 8-10 am on the day following periodontal status assessment.
Malondialdehyde is the most specific and most used molecule for measurement of biological lipid oxidation.
Protein Carbonyl levels in gingival crevicular fluid as measured an oxidative stress marker in proteins
Time frame: between 8-10 am on the day following periodontal status assessment.
Protein carbonyl is another biomarker of oxidative stress
Reduction of total antioxidant capacity levels in gingival crevicular fluid as measured an oxidative stress marker
Time frame: between 8-10 am on the day following periodontal status assessment.
Total antioxidant capacity provides an overview of the biological interaction between an individuals' antioxidant status and how well these antioxidants are able to protect host cells during periods of oxidative stress. Due to the potential synergistic effects of different antioxidant molecules, the measurement of total antioxidant capacity can provide a more accurate assessment of antioxidant status than the separate measurement of individual molecules.
5 secondary outcomes
Plaque index
Time frame: the day before gingival crevicular fluid samples were collected
Gingival index
Time frame: the day before gingival crevicular fluid samples were collected
Bleeding on probing
Time frame: the day before gingival crevicular fluid samples were collected
Pocket probing depth
Time frame: the day before gingival crevicular fluid samples were collected
Clinical attachment level
Time frame: the day before gingival crevicular fluid samples were collected
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 27 Jul 2015.
- Background: PubMed 11234459Obesity: preventing and managing the global epidemic. Report of a WHO consultation. World Health Organ Tech Rep Ser. 2000;894:i-xii, 1-253.
- Background: PubMed 10863370Armitage GC. Development of a classification system for periodontal diseases and conditions. Ann Periodontol. 1999 Dec;4(1):1-6. doi: 10.1902/annals.1999.4.1.1.
- Background: PubMed 14121956LOE H, SILNESS J. PERIODONTAL DISEASE IN PREGNANCY. I. PREVALENCE AND SEVERITY. Acta Odontol Scand. 1963 Dec;21:533-51. doi: 10.3109/00016356309011240. No abstract available.
- Background: PubMed 14158464SILNESS J, LOE H. PERIODONTAL DISEASE IN PREGNANCY. II. CORRELATION BETWEEN ORAL HYGIENE AND PERIODONTAL CONDTION. Acta Odontol Scand. 1964 Feb;22:121-35. doi: 10.3109/00016356408993968. No abstract available.
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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.
Vadim E Atabay, phd principal investigator
research assistant
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Periodontitis, run by Ondokuz Mayıs University.
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 1 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 27 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Malondialdehyde levels in gingival crevicular fluid as measured an oxidative stress marker in lipids (time frame: between 8-10 am on the day following periodontal status assessment.). The study lists 3 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 NCT02508987, which also lists 4 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 27 Jul 2015.