Chronic PeriodontitisNCT03803176
Tissue Plasminogen Activator & Plasminogen Activator Inhibitor Type-1 In Gingival Tissues Of Chronic Periodontitis
An observational study of Chronic Periodontitis, run by Cairo University at 1 site in Egypt.
Trial summary
Tissue Plasminogen Activator and Plasminogen Activator Inhibitor Type-1 Gene Expression will be evaluated clinically and histopathologically through Hematoxylin and eosin as well as by quantitative reverse transcription polymerase chain reaction in the gingival tissues of chronic periodontitis in an attempt to… Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- Open Flap Debridement
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Feb 2018to 14 Aug 2018
- How long will I take part?
- 4 Months
- 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 30 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Study population includes 30 subjects recruited from the outpatient clinic of Oral Medicine \& Periodontology department, Faculty of Dentistry, Cairo University. Ages range from 30-50 years old.
Who may be able to join
- Patients with severe chronic periodontitis
- Pocket depth (PD) of ≥5 mm
- Clinical attachment level (CAL) ≥5 mm
Who cannot join
- Pregnant women
- Subjects taking any type of medication and/or antibiotic therapy during the 3 months before the study
- Subjects who received periodontal treatment within the past 6 months
- Smokers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect Of Periodontal Surgery On Tissue Plasminogen Activator And Plasminogen Activator Inhibitor Type-1 Gene Expression In Gingival Tissues Of Chronic Periodontitis Patients
Tissue Plasminogen Activator and Plasminogen Activator Inhibitor Type-1 Gene Expression will be evaluated clinically and histopathologically through Hematoxylin and eosin as well as by quantitative reverse transcription polymerase chain reaction in the gingival tissues of chronic periodontitis in an attempt to investigate whether the expression of these proteins could be involved in the disease pathogenesis or not, and to assess as well if their expression will be affected by the applied surgical periodontal treatment.
Read the detailed description
30 subjects were enrolled in this study and divided into: Group I (Control Group): 10 periodontally healthy volunteers, Group II (Chronic Periodontitis Group): 20 patients suffering severe CP and Group III (Treated Group): 20 patients who were scheduled for OFD. Gingival samples were collected from all subjects at baseline and at 3 months after OFD from the CP patients. Then, Hematoxylin and eosin (H\&E) stained slides were examined and gene expression levels of t-PA and PAI-1 were measured in the gingiva through quantitative reverse transcription polymerase chain reaction (RT-PCR).
- Conditions
- Chronic Periodontitis
- Being tested
- Open Flap Debridement
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open Flap DebridementProcedure or surgery
Full thickness flaps are elevated to fully expose the periodontaldefects. Defects are then fully debrided and the roots are carefully planned. Flaps are repositioned and sutured to obtain primary closure of the interdental space. This will be done for chronic periodontitis patients
| Study group | Role | What they receive |
|---|---|---|
| Periodontally healthy subjects | Healthy subjects who attended the restorative dental clinic and have clinically healthy gingiva with zero plaque index (PI), gingival index (GI), and CAL (≤3 mm PD). Oral hygeine instructions will be given to these patients. | |
| Chronic Periodontitis | Patients with severe Chronic Periodontitis having a pocket depth (PD) of ≥5 mm and a clinical attachment level (CAL) ≥5 mm. Open flap debridement (surgical periodontal therapy) will be carried out for these patients after scaling \& root planing. Receives: Procedure: Open Flap Debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical attachment level
CAL
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2019
- Study start12 Feb 2018
- Primary completion11 Jun 2018
- Study completion14 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PeriodontitisStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
- Target duration
- 4 Months
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gihane Gharib Madkour, Cairo University
- Investigators
- Gihane G Madkour, Ass Prof, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03803176
- Sponsor's protocol ID
- 12081976
- Status last verified
- Jan 2019
- First submitted
- 10 Jan 2019
- Last updated
- 14 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Periodontal Surgery On Tissue Plasminogen Activator And Plasminogen Activator Inhibitor Type-1 Gene Expression In Gingival Tissues Of Chronic Periodontitis Patients
- ClinicalTrials.gov ID
- NCT03803176
- Acronym / sponsor ID
- 12081976
- Conditions
- Chronic Periodontitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 12 Feb 2018 (actual)
- Primary completion
- 11 Jun 2018 (actual)
- Study completion
- 14 Aug 2018 (actual)
- First posted
- 14 Jan 2019 (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.
Tissue Plasminogen Activator and Plasminogen Activator Inhibitor Type-1 Gene Expression will be evaluated clinically and histopathologically through Hematoxylin and eosin as well as by quantitative reverse transcription polymerase chain reaction in the gingival tissues of chronic periodontitis in an attempt to investigate whether the expression of these proteins could be involved in the disease pathogenesis or not, and to assess as well if their expression will be affected by the applied surgical periodontal treatment.
Detailed description
30 subjects were enrolled in this study and divided into: Group I (Control Group): 10 periodontally healthy volunteers, Group II (Chronic Periodontitis Group): 20 patients suffering severe CP and Group III (Treated Group): 20 patients who were scheduled for OFD. Gingival samples were collected from all subjects at baseline and at 3 months after OFD from the CP patients. Then, Hematoxylin and eosin (H\&E) stained slides were examined and gene expression levels of t-PA and PAI-1 were measured in the gingiva through quantitative reverse transcription polymerase chain reaction (RT-PCR).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 4 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Periodontally healthy subjects | – | –Healthy subjects who attended the restorative dental clinic and have clinically healthy gingiva with zero plaque index (PI), gingival index (GI), and CAL (≤3 mm PD). Oral hygeine instructions will be given to these patients. |
| Chronic Periodontitis | – | Procedure: Open Flap DebridementPatients with severe Chronic Periodontitis having a pocket depth (PD) of ≥5 mm and a clinical attachment level (CAL) ≥5 mm. Open flap debridement (surgical periodontal therapy) will be carried out for these patients after scaling \& root planing. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Study population includes 30 subjects recruited from the outpatient clinic of Oral Medicine \& Periodontology department, Faculty of Dentistry, Cairo University. Ages range from 30-50 years old.
Key inclusion criteria (3 listed)
- Patients with severe chronic periodontitis
- Pocket depth (PD) of ≥5 mm
- Clinical attachment level (CAL) ≥5 mm
Key exclusion criteria (4 listed)
- Pregnant women
- Subjects taking any type of medication and/or antibiotic therapy during the 3 months before the study
- Subjects who received periodontal treatment within the past 6 months
- 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 |
|---|---|---|
| Open Flap DebridementFull thickness flaps are elevated to fully expose the periodontaldefects. Defects are then fully debrided and the roots are carefully planned. Flaps are repositioned and sutured to obtain primary closure of the interdental space. This will be done for chronic periodontitis patients | Procedure or surgery | Chronic Periodontitis |
Primary outcome
Clinical attachment level
Time frame: 4 weeks
CAL
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 14 Jan 2019.
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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.
Gihane G Madkour, Ass Prof principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Periodontitis, run by Cairo 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 3 inclusion and 4 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 14 Jan 2019. 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?
Clinical attachment level (time frame: 4 weeks). 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 14 Jan 2019.