Gingivitis and Periodontal DiseasesCSTF3PGPSRNCT03620396
Comparison of Serum Trefoil Factor 3 in Patients With Gingivitis and Periodontitis After Scaling and Root Planing
A study testing Scaling and root planing in people with Gingivitis and Periodontal Diseases, run by Dr.K.Sai Priyanka.
Trial summary
This study is intended to measure serum trefoil factor 3 at baseline and 3 months after, following nonsurgical periodontal therapy in patients with Gingivitis and Chronic Periodontitis. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Gingivitis and Periodontal Diseases
- What is being tested?
- Scaling and root planing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2016to 19 Feb 2017
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- For Gingivitis:
- Gingival Index: 1.1 to 2.
- Modifies Plaque Index: 1.0 to 1.9
- For Periodontitis:
- Gingival Index: 1.1 to 2.
- Modifies Plaque Index: 1.0 to 1.9
- Probing depth > 4mm
- Clinical attachment loss > 2mm
Who cannot join
- For Gingivitis:
- Presence of gingival recession.
- Presence of clinical attachment loss.
- Presence of furcation.
- Presence of systemic infections like diabetes, infections.
- Smokers.
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- Antibiotic therapy received preceding 3 months.
- Patients who underwent periodontal therapy within 3 months.
- Pregnant and Lactating women.
- For Periodontitis:
- Presence of any systemic conditions like diabetes, infections.
- Smokers.
- Antibiotic therapy received preceding 3 months.
- Patients who underwent periodontal therapy within 3 months.
- Pregnant and Lactating women.
About this study
Official title: Comparison of Serum Levels of Trefoil Factor 3 in Patients With Gingivitis and Periodontitis Following Non Surgical Periodontal Therapy
This study is intended to measure serum trefoil factor 3 at baseline and 3 months after, following nonsurgical periodontal therapy in patients with Gingivitis and Chronic Periodontitis.
Read the detailed description
A goal of periodontal diagnostic procedure is to provide useful information to the clinician regarding the present periodontal disease type and severity. Advances in diagnostic research are moving towards methods where periodontal risk can be identified and quantified by objective measures such as Biomarkers.
Trefoil factors (TFFs) are one such secreted molecules derived from mucin producing epithelial cells of the gastro intestinal tracts and other tissues such as Salivary glands, Parotid ducts and oral mucosa. Among three Trefoil factors reported, Trefoil Factor 3 (TFF3) is the modifying factor for signalling pathway involved in cell survival, cell proliferation and cell migration of oral keratinocytes. Hence assessing the marker levels would achieve beneficial effects on diagnosing the disease severity.
- Conditions
- Gingivitis and Periodontal Diseases
- Being tested
- Scaling and root planing
- Medical subject headings
- Gingivitis, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scaling and root planingProcedure or surgery
After the serum collection is done from the patient for the assessment of trefoil factor 3, Non surgical periodontal therapy is carried out.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Interventional | Experimental | Group A patients consists of Gingivitis patients whose serum is collected at base line and treated with Scaling and root planing and after three months serum is collected for assessment of Trefoil factor 3. Receives: Procedure: Scaling and root planing |
| Experimental Interventional | Experimental | Group B patients consists of Periodontitis patients whose serum is collected at base line and treated with Scaling and Root Planing and after three months serum is collected for assessment of Trefoil factor 3. Receives: Procedure: Scaling and root planing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trefoil factor 3
Blood samples were collected by venepuncture of anti-cubital vein. 2ml of blood was collected in each test tube. 10 minutes after collection, the test tube containing 2ml blood was subjected to centrifugation at 3000rpm for 10 min. The supernatant straw colored fluid (serum) was separated into storage vials (Eppendorf tubes) for serum Trefoil Factor 3.
Measured: 3 months.
Secondary outcomes (4)
Change in the Gingival Index.
The severity of gingivitis is scored on all surfaces of selected teeth using Williams Periodontal probe.
Index teeth- 16, 12, 24, 36, 32, 44. Score around each tooth is totalled and divided by 4-score of tooth. 0.1-1.0: Mild gingivitis. 1.1-2.0:Moderate gingivitis 2.1-3.0:Severe gingivitis
Measured: 3 months
Change in Modified Plaque Index
Examination of all the surfaces of the teeth are done using an explorer. The scores for individual teeth may be grouped and totalled and divided by the number of teeth.
Excellent:0 Good:0.1-0.9 Fair:1.0-1.9 Poor:2-3
Measured: 3 months
Change in Probing depth
The distance from the gingival margin to the depth of the pocket is measured using Williams periodontal probe.
Measured: 3 months
Change in Clinical Attachment loss
The distance from the cementoenamel junction to the tip of the alveolar crest is measures using Williams periodontal probe.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start15 Oct 2016
- Primary completion17 Jan 2017
- Study completion19 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gingivitis and Periodontal DiseasesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be equally divided into two test groups.Group A consists of Gingivitis patients and Group B consists of Periodontitis patients. Both the group patients have been evaluated for Serum Trefoil factor 3 at baseline and treated with non surgical periodontal therapy. After three months both the group patients were again assessed for serum trefoil factor 3.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr.K.Sai Priyanka
- Sponsor type
- University, hospital or other
- Collaborators
- Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
- Responsible party
- Sponsor-investigator, Dr.K.Sai Priyanka, Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03620396
- Sponsor's protocol ID
- Panineeya Mahavidyalaya
- Other IDs
- D159206045
- Acronym
- CSTF3PGPSR
- Status last verified
- Aug 2018
- First submitted
- 3 Aug 2018
- Last updated
- 13 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chaiyarit P, Chayasadom A, Wara-Aswapati N, Hormdee D, Sittisomwong S, Nakaresisoon S, Samson MH, Pitiphat W, Giraud AS. Trefoil factors in saliva and gingival tissues of patients with chronic periodontitis. J Periodontol. 2012 Sep;83(9):1129-38. doi: 10.1902/jop.2011.110431. Epub 2011 Dec 19.
PubMed 22181686Storesund T, Schreurs O, Messelt EB, Kolltveit KM, Schenck K. Trefoil factor family 3 expression in the oral cavity. Eur J Oral Sci. 2009 Dec;117(6):636-43. doi: 10.1111/j.1600-0722.2009.00679.x.
PubMed 20121925
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Serum Levels of Trefoil Factor 3 in Patients With Gingivitis and Periodontitis Following Non Surgical Periodontal Therapy
- ClinicalTrials.gov ID
- NCT03620396
- Acronym / sponsor ID
- CSTF3PGPSR / Panineeya Mahavidyalaya
- Conditions
- Gingivitis and Periodontal Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Dr.K.Sai PriyankaUniversity, hospital or other
- Collaborators
- Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
- Study start
- 15 Oct 2016 (actual)
- Primary completion
- 17 Jan 2017 (actual)
- Study completion
- 19 Feb 2017 (actual)
- First posted
- 8 Aug 2018 (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.
This study is intended to measure serum trefoil factor 3 at baseline and 3 months after, following nonsurgical periodontal therapy in patients with Gingivitis and Chronic Periodontitis.
Detailed description
A goal of periodontal diagnostic procedure is to provide useful information to the clinician regarding the present periodontal disease type and severity. Advances in diagnostic research are moving towards methods where periodontal risk can be identified and quantified by objective measures such as Biomarkers.
Trefoil factors (TFFs) are one such secreted molecules derived from mucin producing epithelial cells of the gastro intestinal tracts and other tissues such as Salivary glands, Parotid ducts and oral mucosa. Among three Trefoil factors reported, Trefoil Factor 3 (TFF3) is the modifying factor for signalling pathway involved in cell survival, cell proliferation and cell migration of oral keratinocytes. Hence assessing the marker levels would achieve beneficial effects on diagnosing the disease severity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be equally divided into two test groups.Group A consists of Gingivitis patients and Group B consists of Periodontitis patients. Both the group patients have been evaluated for Serum Trefoil factor 3 at baseline and treated with non surgical periodontal therapy. After three months both the group patients were again assessed for serum trefoil factor 3.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Interventional | Experimental | Procedure: Scaling and root planingGroup A patients consists of Gingivitis patients whose serum is collected at base line and treated with Scaling and root planing and after three months serum is collected for assessment of Trefoil factor 3. |
| Experimental Interventional | Experimental | Procedure: Scaling and root planingGroup B patients consists of Periodontitis patients whose serum is collected at base line and treated with Scaling and Root Planing and after three months serum is collected for assessment of Trefoil factor 3. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Gingival Index: 1.1 to 2.
- Modifies Plaque Index: 1.0 to 1.9
- Gingival Index: 1.1 to 2.
- Modifies Plaque Index: 1.0 to 1.9
- Probing depth > 4mm
Key exclusion criteria (15 listed)
- Presence of gingival recession.
- Presence of clinical attachment loss.
- Presence of furcation.
- Presence of systemic infections like diabetes, infections.
- Smokers.
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 |
|---|---|---|
| Scaling and root planingAfter the serum collection is done from the patient for the assessment of trefoil factor 3, Non surgical periodontal therapy is carried out. | Procedure or surgery | Experimental Interventional, Experimental: Interventional |
Primary outcome
Trefoil factor 3
Time frame: 3 months.
Blood samples were collected by venepuncture of anti-cubital vein. 2ml of blood was collected in each test tube. 10 minutes after collection, the test tube containing 2ml blood was subjected to centrifugation at 3000rpm for 10 min. The supernatant straw colored fluid (serum) was separated into storage vials (Eppendorf tubes) for serum Trefoil Factor 3.
4 secondary outcomes
Change in the Gingival Index.
Time frame: 3 months
Change in Modified Plaque Index
Time frame: 3 months
Change in Probing depth
Time frame: 3 months
Change in Clinical Attachment loss
Time frame: 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 13 Aug 2018.
- Background: PubMed 22181686Chaiyarit P, Chayasadom A, Wara-Aswapati N, Hormdee D, Sittisomwong S, Nakaresisoon S, Samson MH, Pitiphat W, Giraud AS. Trefoil factors in saliva and gingival tissues of patients with chronic periodontitis. J Periodontol. 2012 Sep;83(9):1129-38. doi: 10.1902/jop.2011.110431. Epub 2011 Dec 19.
- Background: PubMed 20121925Storesund T, Schreurs O, Messelt EB, Kolltveit KM, Schenck K. Trefoil factor family 3 expression in the oral cavity. Eur J Oral Sci. 2009 Dec;117(6):636-43. doi: 10.1111/j.1600-0722.2009.00679.x.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Scaling and root planing in people with Gingivitis and Periodontal Diseases, run by Dr.K.Sai Priyanka.
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 8 inclusion and 15 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 13 Aug 2018. 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?
Trefoil factor 3 (time frame: 3 months.). 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 NCT03620396, which also lists 2 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 13 Aug 2018.