ObesityNCT07571850
Gingival Crevicular Fluid Levels of Prolactin Hormone in Obese Patients With Stage ii and Iii Periodontitis Before and After Non-surgical Periodontal Therapy
A study testing Obese patients with stage II and III periodontitis and non surgical peridontal therapy in people with Obesity and Periodontal Diseases, run by Alexandria University at 1 site in Egypt.
Trial summary
Obesity and periodontitis are among the most common chronic disorders affecting the world population, while Prolactin (PRL) is a neuroendocrine hormone that within the physiological range stimulates bone formation while mild to marked increase in its level induces bone resorption and inhibits bone formation. Read more about this study
- Who is it for?
- Ages 25 to 55 years, women only
- Conditions the study is for
- Obesity, Periodontal Diseases
- What is being tested?
- Obese patients with stage II and III periodontitis and non surgical peridontal therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2024to 30 Jun 2025
- 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 25 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Body mass index (more than 29.9 kg/m2).
- stage II and III periodontitis
Who cannot join
- Pregnancy or lactation.
- Any known systemic disease other than obesity
- Previous periodontal treatment (surgical or non-surgical) in last 6 months;
- Antibiotics in the past 3 months.
- Smoking
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient Clinic of Periodontology and Oral medicine Department, Faculty of Dentistry, Alexandria University, Egypt
Alexandria
About this study
Official title: Gingival Crevicular Fluid Levels of Prolactin Hormone in Obese Patients With Stage ii and Iii Periodontitis Before and After Non-surgical Periodontal Therapy (a Comparative Clinical Study)
Obesity and periodontitis are among the most common chronic disorders affecting the world population, while Prolactin (PRL) is a neuroendocrine hormone that within the physiological range stimulates bone formation while mild to marked increase in its level induces bone resorption and inhibits bone formation.
Aim of the study: study aims to investigate prolactin (PRL) levels in gingival crevicular fluid (GCF) in obese (O) patients with and without stage II and III periodontitis (P). Further, to evaluate the effect of non-surgical periodontal therapy on these levels compared to controls.
- Conditions
- Obesity, Periodontal Diseases
- Being tested
- Obese patients with stage II and III periodontitis and non surgical peridontal therapy, obese patients with healthy periodontium with no intervention
- Medical subject headings
- Obesity, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obese patients with stage II and III periodontitis and non surgical peridontal therapyOther
Patients had BMI of more than 29.9 kg/m2. charaterized by Stage II periodontitis with clinical attachment loss of 3-4 mm, radiographic bone loss confined to the coronal third, and no history of tooth loss due to infection and Stage III signifies severe destruction with attachment loss of more th toan or equal 5 mm, bone loss extending into the middle or apical third of the root, and potential tooth loss of up to four teeth. Patients will undergo full mouth scaling and root planning for two sessions
obese patients with healthy periodontium with no interventionOther
Patients had BMI of more than 29.9 kg/m2 but with healthy peridontium
| Study group | Role | What they receive |
|---|---|---|
| Patients with peridontal disease | Experimental | Not described Receives: Other: Obese patients with stage II and III periodontitis and non surgical peridontal therapy |
| Patients without peridontal disease | Active comparator | Not described Receives: Other: obese patients with healthy periodontium with no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in clinical attachment level
Clinical attachment level (CAL) using a Williams probe (which manufactured in Europe from AISI 304 Stainless steel) from a fixed reference point on the crown to the base of the pocket.
Measured: Baseline and 3 months
change in GCF levels of prolactin hormone
Gingival crevicular fluid sample will be obtained from the buccal aspects of two interproximal sites in teeth that will have the highest signs of inflammation and attachment loss
Measured: Baseline and 3 months
Secondary outcomes (3)
change in Probing depth
measured from the margin of the gingiva to the base of the pocket until slight resistance is encountered using a Williams probe (which manufactured in Europe from AISI 304 Stainless steel).
Measured: Baseline and 3 months
change in gingival index
Gingival Index evaluates the severity of gingivitis by scoring the color, consistency, and bleeding tendency of the soft tissues on a scale of 0 to 3, where a score of 2 indicates bleeding upon probing and a 3 signifies spontaneous bleeding
Measured: Baseline and 3 months
change in plaque index
Plaque Index focuses exclusively on the thickness of the microbial biofilm at the gingival margin, ranging from a score of 1, where plaque is only detectable by running a probe across the surface, to a score of 3, characterized by an abundance of visible soft matter.
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start1 Oct 2024
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07571850
- Sponsor's protocol ID
- 0857-02/2024
- Status last verified
- Apr 2026
- First submitted
- 18 Apr 2026
- Last updated
- 6 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gingival Crevicular Fluid Levels of Prolactin Hormone in Obese Patients With Stage ii and Iii Periodontitis Before and After Non-surgical Periodontal Therapy (a Comparative Clinical Study)
- ClinicalTrials.gov ID
- NCT07571850
- Acronym / sponsor ID
- 0857-02/2024
- Conditions
- Obesity, Periodontal Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 6 May 2026 (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.
Obesity and periodontitis are among the most common chronic disorders affecting the world population, while Prolactin (PRL) is a neuroendocrine hormone that within the physiological range stimulates bone formation while mild to marked increase in its level induces bone resorption and inhibits bone formation.
Aim of the study: study aims to investigate prolactin (PRL) levels in gingival crevicular fluid (GCF) in obese (O) patients with and without stage II and III periodontitis (P). Further, to evaluate the effect of non-surgical periodontal therapy on these levels compared to controls.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with peridontal disease | Experimental | Other: Obese patients with stage II and III periodontitis and non surgical peridontal therapy |
| Patients without peridontal disease | Active comparator | Other: obese patients with healthy periodontium with no intervention |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body mass index (more than 29.9 kg/m2).
- stage II and III periodontitis
Key exclusion criteria (5 listed)
- Pregnancy or lactation.
- Any known systemic disease other than obesity
- Previous periodontal treatment (surgical or non-surgical) in last 6 months;
- Antibiotics in the past 3 months.
- Smoking
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 |
|---|---|---|
| Obese patients with stage II and III periodontitis and non surgical peridontal therapyPatients had BMI of more than 29.9 kg/m2. charaterized by Stage II periodontitis with clinical attachment loss of 3-4 mm, radiographic bone loss confined to the coronal third, and no history of tooth loss due to infection and Stage III signifies severe destruction with attachment loss of more th toan or equal 5 mm, bone loss extending into the middle or apical third of the root, and potential tooth loss of up to four teeth. Patients will undergo full mouth scaling and root planning for two sessions | Other | Patients with peridontal disease |
| obese patients with healthy periodontium with no interventionPatients had BMI of more than 29.9 kg/m2 but with healthy peridontium | Other | Patients without peridontal disease |
Primary outcome
change in clinical attachment level
Time frame: Baseline and 3 months
Clinical attachment level (CAL) using a Williams probe (which manufactured in Europe from AISI 304 Stainless steel) from a fixed reference point on the crown to the base of the pocket.
change in GCF levels of prolactin hormone
Time frame: Baseline and 3 months
Gingival crevicular fluid sample will be obtained from the buccal aspects of two interproximal sites in teeth that will have the highest signs of inflammation and attachment loss
3 secondary outcomes
change in Probing depth
Time frame: Baseline and 3 months
change in gingival index
Time frame: Baseline and 3 months
change in plaque index
Time frame: Baseline and 3 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 6 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Obese patients with stage II and III periodontitis and non surgical peridontal therapy in people with Obesity and Periodontal Diseases, run by Alexandria 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 2 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 6 May 2026. 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?
change in clinical attachment level (time frame: Baseline and 3 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?
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 6 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.