Menopausal PatientsPhase 4NCT06254118
Treatment of Periodontitis in Menopausal Patients
A Phase 4 study testing Polyunsaturated Fatty Acids and olive oil in people with Menopausal Patients and Chronic Periodontitis, run by Hadir F. El-Dessouky at 1 site in Saudi Arabia.
Trial summary
The goal of this clinical trial is to compare the effectiveness of polyunsaturated fatty acids (PUFAs) [omega-3] as an adjunctive treatment to scaling and root planing for menopausal women with periodontitis versus scaling and root alone as a non- surgical treatment . . Read more about this study
- Who is it for?
- Ages 45 to 55 years, women only
- Conditions the study is for
- Menopausal Patients, Chronic Periodontitis, Omega 3 Fatty Acids
- What is being tested?
- Polyunsaturated Fatty Acids and olive oil
- 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 siteSaudi Arabia
- Study dates
- 22 Jan 2020to 30 Jan 2023
- Phase
- Phase 4
- 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 45 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- patients diagnosed as; periodontitis patients
- presence of a minimum of 6 teeth in the mouth
- at least 3 periodontal sites with probing pocket depth more or equal to 5mm
- women experiencing menopause for at least a year
Who cannot join
- women suffering from any systemic disorder that might affect the periodontal tissues such as; Diabetes Mellitus, immune disorders,..
- anemic patients
- smokers
- patients taking NSAIDs, supplements, antibiotics regularly used mouthwashes within the last 3 months
- participants in any other clinical trials
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-Surgical Treatment of Periodontitis in Menopausal Patients
The goal of this clinical trial is to compare the effectiveness of polyunsaturated fatty acids (PUFAs) [omega-3] as an adjunctive treatment to scaling and root planing for menopausal women with periodontitis versus scaling and root alone as a non- surgical treatment .
. The main question it aims to answer is:
Read more
- to investigate the effect of systemic administration of Omega-3 fatty acids in addition to SRP on clinical periodontal parameters and GCF levels of osteocalcin and AST in menopausal women.
Participants will given * a soft gelatin capsules containing PUFAs to be consumed directly once daily for 12 months along with non-surgical treatment (group2)
** a soft gelatin capsules containing olive oil to be consumed directly once daily for 12 months along with non-surgical treatment (group1)
Researchers will compare group 1 to group 2 to see if PUFAs has an effect on clinical periodontal parameters and GCF levels of osteocalcin and AST in menopausal women. .
Read the detailed description
Menopause is typically accompanied by significant systemic and oral manifestations, including hormonal changes and increased susceptibility to periodontal disease, which may involve inflammatory biomarkers like aspartate aminotransferase (AST) and Osteocalcin in gingival crevicular fluid (GCF). The study aims to evaluate the effectiveness of regular inoculation of polyunsaturated fatty acids (PUFAs) as an adjunctive treatment for menopausal women's periodontitis.
Methods: Twenty elderly women with chronic periodontitis were split evenly into two groups by random assignment. Patients in group II (the research group) were given soft gelatin capsules containing PUFAs to be consumed directly once daily for 12 months, as opposed to the group I (the control group), who received soft gelatin capsules containing some olive oil (placebo). Scaling and root planning (SRP) were used to address periodontal disease in all cases.
At baseline, six and twelve months after treatment, clinical indicators and AST and Osteocalcin amounts in the GCF will be noted.
- Being tested
- Polyunsaturated Fatty Acids, olive oil
- Keywords
- Periodontitis, GCF, Osteocalcin.
- Medical subject headings
- Chronic Periodontitis, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyunsaturated Fatty AcidsDrug
Also called omega-3 fatty acids
1000mg omega-3 fatty acids taken once daily with meals for 12 months
olive oilDietary supplement
1000mg olive oil taken once daily with meals for 12 months
| Study group | Role | What they receive |
|---|---|---|
| group 2 polyunsaturated fatty acids | Experimental | intervention: systemic administration of 1000 mg polyunsaturated fatty acids. to be taken once daily with meals for 12 months
patients treated by scaling and root planing and oral systemic administration of Omega-3 fatty acids a soft gelatinous capsule containing 1000 mg polyunsaturated fatty acids (PUFAs) Receives: Drug: Polyunsaturated Fatty Acids |
| group 1 control | Sham comparator | control group, patients treated by scaling and root planing and an oral soft gelatinous capsule containing olive oil to be taken once daily with meals for 12 months Receives: Dietary Supplement: olive oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
aspartate aminotransferase (AST) in gingival crevicular fluid (GCF).
AST in GCF will be measured in 20 participants, evaluation of AST in the collected GCF. The assessment was done using the VITROS Dry Technology 60 Chemistry System which can provide accurate results using even very small amounts of GCF (~10 µl). The principle behind the test is to evaluate the enzymatic activity of AST to convert the amino group of aspartates where the oxidation process of nicotinamide adenine dinucleotide (NAD) + hydrogen (H) (NADH+). This activity is measured by the Reflectance Spectrophotometry at 340nm wavelength and 37°C. The change in rate assesses the enzymatic activity as per Bergmeyer et al. method.
Measured: baseline, 6 months, 12 months
Osteocalcin in gingival crevicular fluid (GCF).
Osteocalcin in GCF, The evaluation of the level of osteocalcin in the GCF sample, using enzyme-linked immunosorbent assay (ELISA) kits (Ani Biotech Oy, AvioBion, Finland), is the next step in the study. The osteocalcin levels are measured in nanograms per milliliter (ng/mL) when assessed using ELISA kits. The principle applied in the sandwich-type ELISA kit is the presence of a monoclonal osteocalcin which is adsorbed onto the well of the kit and then binds to the osteocalcin (present in the sample). The amount of osteocalcin present was assessed using standard curves based on dilutions and measured at the color intensity of 450nm.
Measured: baseline, 6 months, 12 months
Secondary outcomes (4)
Plaque Index (PI)
The PI was conducted according to O'Leary et al. (1972), this precise index records the presence of supra-gingival plaque on all four tooth surfaces. For this test, the plaque is disclosed using a disclosing tablet. and the stained surfaces around the gingival margins were recorded. the presence or absence of plaque is recorded in a simple chart, the plaque incidence in the oral cavity is expressed as an exact percentage, maximum index is 100%, minimum index is 0%.
Measured: baseline, 6 months, 12 months
Gingival index (GI)
GI was recorded according to Loe and Silness (1963), the gingival index records gingival inflammation in three grades. It is measured on six selected teeth, on facial, lingual, mesial and distal sites. Grades range from 0-3. 0= normal gingiva; no inflammation, no discoloration (erythema), no bleeding. 1= mild inflammation; slight erythema, no bleeding. 2= moderate inflammation; erythema bleeding on probing. (the symptom of bleeding comprises a score of 2). 3= severe inflammation, severe erythema and swelling, tendency to spontaneous bleeding.
Measured: baseline, 6 months, 12 months
Probing pocket depth (PPD)
The examination of PPD was conducted using a UNC-15 periodontal probe (UNC-15, Hu-Friedy, Chicago, IL, USA). PPD was measured at 6 points around each tooth Mesiobuccal (MB), midbuccal (B), Distobuccal (DB), Mesiolingual (ML), midlingual (L), and Distolingual (DL).
UNC-15 periodontal probe measures 15mm, PPD of 5mm or more were recorded.
Measured: baseline, 6 months, 12 months
Clinical attachment level (CAL)
The examination of CAL was conducted using a UNC-15 periodontal probe (UNC-15, Hu-Friedy, Chicago, IL, USA). CAL was measured at 6 points around each tooth Mesiobuccal (MB), midbuccal (B), Distobuccal (DB), Mesiolingual (ML), midlingual (L), and Distolingual (DL).
UNC-15 periodontal probe measures 15mm, CAL of 1mm or more were recorded.
Measured: baseline, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start22 Jan 2020
- Primary completion22 Jan 2022
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Menopausal PatientsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadir F. El-Dessouky
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hadir F. El-Dessouky, King Abdulaziz University
- Investigators
- ELDESSOUKY, Principal investigator, King Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06254118
- Sponsor's protocol ID
- HElDessouky
- Status last verified
- Feb 2024
- First submitted
- 28 Jan 2024
- Last updated
- 12 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no IPD to be shared
Publications
Eldessouky HF, Marie M. Nonsurgical Treatment of Periodontitis in Menopausal Patients: A Randomized Control Trial. Biomed Res Int. 2024 Mar 13;2024:6997142. doi: 10.1155/2024/6997142. eCollection 2024.
PubMed 38510979
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Surgical Treatment of Periodontitis in Menopausal Patients
- ClinicalTrials.gov ID
- NCT06254118
- Acronym / sponsor ID
- HElDessouky
- Keywords
- Periodontitis, GCF, Osteocalcin.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hadir F. El-DessoukyUniversity, hospital or other
- Study start
- 22 Jan 2020 (actual)
- Primary completion
- 22 Jan 2022 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 12 Feb 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 compare the effectiveness of polyunsaturated fatty acids (PUFAs) [omega-3] as an adjunctive treatment to scaling and root planing for menopausal women with periodontitis versus scaling and root alone as a non- surgical treatment .
. The main question it aims to answer is:
- to investigate the effect of systemic administration of Omega-3 fatty acids in addition to SRP on clinical periodontal parameters and GCF levels of osteocalcin and AST in menopausal women.
Participants will given * a soft gelatin capsules containing PUFAs to be consumed directly once daily for 12 months along with non-surgical treatment (group2)
** a soft gelatin capsules containing olive oil to be consumed directly once daily for 12 months along with non-surgical treatment (group1)
Researchers will compare group 1 to group 2 to see if PUFAs has an effect on clinical periodontal parameters and GCF levels of osteocalcin and AST in menopausal women. .
Detailed description
Menopause is typically accompanied by significant systemic and oral manifestations, including hormonal changes and increased susceptibility to periodontal disease, which may involve inflammatory biomarkers like aspartate aminotransferase (AST) and Osteocalcin in gingival crevicular fluid (GCF). The study aims to evaluate the effectiveness of regular inoculation of polyunsaturated fatty acids (PUFAs) as an adjunctive treatment for menopausal women's periodontitis.
Methods: Twenty elderly women with chronic periodontitis were split evenly into two groups by random assignment. Patients in group II (the research group) were given soft gelatin capsules containing PUFAs to be consumed directly once daily for 12 months, as opposed to the group I (the control group), who received soft gelatin capsules containing some olive oil (placebo). Scaling and root planning (SRP) were used to address periodontal disease in all cases.
At baseline, six and twelve months after treatment, clinical indicators and AST and Osteocalcin amounts in the GCF will be noted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 2 polyunsaturated fatty acids | Experimental | Drug: Polyunsaturated Fatty Acidsintervention: systemic administration of 1000 mg polyunsaturated fatty acids. to be taken once daily with meals for 12 months patients treated by scaling and root planing and oral systemic administration of Omega-3 fatty acids a soft gelatinous capsule containing 1000 mg polyunsaturated fatty acids (PUFAs) |
| group 1 control | Sham comparator | Dietary Supplement: olive oilcontrol group, patients treated by scaling and root planing and an oral soft gelatinous capsule containing olive oil to be taken once daily with meals for 12 months |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- patients diagnosed as; periodontitis patients
- presence of a minimum of 6 teeth in the mouth
- at least 3 periodontal sites with probing pocket depth more or equal to 5mm
- women experiencing menopause for at least a year
Key exclusion criteria (5 listed)
- women suffering from any systemic disorder that might affect the periodontal tissues such as; Diabetes Mellitus, immune disorders,..
- anemic patients
- smokers
- patients taking NSAIDs, supplements, antibiotics regularly used mouthwashes within the last 3 months
- participants in any other clinical trials
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 |
|---|---|---|
| Polyunsaturated Fatty AcidsAlso: omega-3 fatty acids1000mg omega-3 fatty acids taken once daily with meals for 12 months | Drug | group 2 polyunsaturated fatty acids |
| olive oil1000mg olive oil taken once daily with meals for 12 months | Dietary supplement | group 1 control |
Primary outcome
aspartate aminotransferase (AST) in gingival crevicular fluid (GCF).
Time frame: baseline, 6 months, 12 months
AST in GCF will be measured in 20 participants, evaluation of AST in the collected GCF. The assessment was done using the VITROS Dry Technology 60 Chemistry System which can provide accurate results using even very small amounts of GCF (~10 µl). The principle behind the test is to evaluate the enzymatic activity of AST to convert the amino group of aspartates where the oxidation process of nicotinamide adenine dinucleotide (NAD) + hydrogen (H) (NADH+). This activity is measured by the Reflectance Spectrophotometry at 340nm wavelength and 37°C. The change in rate assesses the enzymatic activity as per Bergmeyer et al. method.
Osteocalcin in gingival crevicular fluid (GCF).
Time frame: baseline, 6 months, 12 months
Osteocalcin in GCF, The evaluation of the level of osteocalcin in the GCF sample, using enzyme-linked immunosorbent assay (ELISA) kits (Ani Biotech Oy, AvioBion, Finland), is the next step in the study. The osteocalcin levels are measured in nanograms per milliliter (ng/mL) when assessed using ELISA kits. The principle applied in the sandwich-type ELISA kit is the presence of a monoclonal osteocalcin which is adsorbed onto the well of the kit and then binds to the osteocalcin (present in the sample). The amount of osteocalcin present was assessed using standard curves based on dilutions and measured at the color intensity of 450nm.
4 secondary outcomes
Plaque Index (PI)
Time frame: baseline, 6 months, 12 months
Gingival index (GI)
Time frame: baseline, 6 months, 12 months
Probing pocket depth (PPD)
Time frame: baseline, 6 months, 12 months
Clinical attachment level (CAL)
Time frame: baseline, 6 months, 12 months
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 12 Feb 2024.
- Derived from this study: PubMed 38510979Eldessouky HF, Marie M. Nonsurgical Treatment of Periodontitis in Menopausal Patients: A Randomized Control Trial. Biomed Res Int. 2024 Mar 13;2024:6997142. doi: 10.1155/2024/6997142. eCollection 2024.
- Individual participant dataSharing planned: No. no IPD to be shared
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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.
ELDESSOUKY principal investigator
King Abdulaziz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Polyunsaturated Fatty Acids and olive oil in people with Menopausal Patients and Chronic Periodontitis, run by Hadir F. El-Dessouky at 1 site in Saudi Arabia.
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 12 Feb 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 Saudi Arabia. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
aspartate aminotransferase (AST) in gingival crevicular fluid (GCF). (time frame: baseline, 6 months, 12 months). 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 NCT06254118, which also lists 1 linked publication.
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 12 Feb 2024.