Chronic PeriodontitisNCT02861326
RELATIONSHIP BETWEEN INITIAL PROBING DEPTH AND CHANGES IN CLINICAL PARAMETERS FOLLOWING NON-SURGICAL PERIODONTAL TREATMENT IN CHRONIC PERIODONTITIS PATIENTS
A study testing Gracey Curettes in people with Chronic Periodontitis, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
Aim: The aim of this study was to evaluate the relationship between initial probing depth (IPD) and changes in clinical parameters following non-surgical periodontal treatment (NPT) in chronic periodontitis patients. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- Gracey Curettes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2014to Jan 2015
- 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 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Systemically healthy,
- Non-smoker,
- Chronic periodontitis diagnosed according to Armitage 1,
- Aged between 35 and 65,
- Not received any periodontal treatment within the last 3 months, • Have horizontal bone loss radiographically,
- Presence at least 20 natural teeth except third molars
- Consent to participate in the study.
Who cannot join
- Any systemic disease that might interfere with the prognosis of periodontal disease (i.e. diabetes mellitus, HIV infection),
- Smoking,
- Antibiotics, anti-inflammatory drugs or any other medication taken within the previous 6 months that may affect the outcome of the study,
- Any physical limitations or restrictions that might preclude normal oral hygiene procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Aim: The aim of this study was to evaluate the relationship between initial probing depth (IPD) and changes in clinical parameters following non-surgical periodontal treatment (NPT) in chronic periodontitis patients.
Material and Methods: A total of 1672 periodontal pockets having 3 mm≤IPD≤9 mm in 15 chronic periodontitis patients were included. NPT consisting of oral hygiene instructions, scaling and root planing was applied in two sessions. Probing depth (PD), clinical attachment level, gingival recession (GR) were measured before and eight weeks after treatment. Pocket sites were grouped according to their IPD and root number of teeth as single- or multi-rooted.
- Conditions
- Chronic Periodontitis
- Being tested
- Gracey Curettes
- Keywords
- chronic periodontitis, dental scaling, periodontal pockets
- Medical subject headings
- Chronic Periodontitis, Periodontal Pocket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gracey CurettesDevice
Also called Hu-Friedy, SG 5/6, 7/8, 11/12, 13/14, Hu-Friedy Ins. Co., USA
| Study group | Role | What they receive |
|---|---|---|
| Patients | Other | Non-surgical periodontal treatment has performed to patients. Scaling and root planing were performed with Gracey curettes until the operator feels that root surface is clean, hard and smooth. Receives: Device: Gracey Curettes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing Depth
Probing depth is defined as the distance from the free gingival margin to the bottom of the periodontal pocket.
Measured: 8 week
Secondary outcomes (2)
Clinical attachment level
Clinical attachment level is defined as the distance from the cementoenamel junction to the bottom of the periodontal pocket
Measured: 8 week
Gingival recession
Gingival recession is defined as the distance from cementoenamel junction to free gingival margin.
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2016 (estimated)
- Study startJan 2014
- Primary completionJan 2015
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02861326
- Sponsor's protocol ID
- Meseli
- Status last verified
- Aug 2016
- First submitted
- 5 Aug 2016
- Last updated
- 10 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RELATIONSHIP BETWEEN INITIAL PROBING DEPTH AND CHANGES IN CLINICAL PARAMETERS FOLLOWING NON-SURGICAL PERIODONTAL TREATMENT IN CHRONIC PERIODONTITIS PATIENTS
- ClinicalTrials.gov ID
- NCT02861326
- Acronym / sponsor ID
- Meseli
- Conditions
- Chronic Periodontitis
- Keywords
- chronic periodontitis, dental scaling, periodontal pockets
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2015 (actual)
- First posted
- 10 Aug 2016 (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.
Aim: The aim of this study was to evaluate the relationship between initial probing depth (IPD) and changes in clinical parameters following non-surgical periodontal treatment (NPT) in chronic periodontitis patients.
Material and Methods: A total of 1672 periodontal pockets having 3 mm≤IPD≤9 mm in 15 chronic periodontitis patients were included. NPT consisting of oral hygiene instructions, scaling and root planing was applied in two sessions. Probing depth (PD), clinical attachment level, gingival recession (GR) were measured before and eight weeks after treatment. Pocket sites were grouped according to their IPD and root number of teeth as single- or multi-rooted.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | Other | Device: Gracey CurettesNon-surgical periodontal treatment has performed to patients. Scaling and root planing were performed with Gracey curettes until the operator feels that root surface is clean, hard and smooth. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Systemically healthy,
- Non-smoker,
- Chronic periodontitis diagnosed according to Armitage 1,
- Aged between 35 and 65,
- Not received any periodontal treatment within the last 3 months, • Have horizontal bone loss radiographically,
Key exclusion criteria (4 listed)
- Any systemic disease that might interfere with the prognosis of periodontal disease (i.e. diabetes mellitus, HIV infection),
- Smoking,
- Antibiotics, anti-inflammatory drugs or any other medication taken within the previous 6 months that may affect the outcome of the study,
- Any physical limitations or restrictions that might preclude normal oral hygiene procedures.
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 |
|---|---|---|
| Gracey CurettesAlso: Hu-Friedy, SG 5/6, 7/8, 11/12, 13/14, Hu-Friedy Ins. Co., USA | Device | Patients |
Primary outcome
Probing Depth
Time frame: 8 week
Probing depth is defined as the distance from the free gingival margin to the bottom of the periodontal pocket.
2 secondary outcomes
Clinical attachment level
Time frame: 8 week
Gingival recession
Time frame: 8 week
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 10 Aug 2016.
- Individual participant dataSharing planned: No
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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 Gracey Curettes in people with Chronic Periodontitis, run by Marmara University at 1 site in Turkey (Türkiye).
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 7 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 10 Aug 2016. 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 Turkey (Türkiye). 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?
Probing Depth (time frame: 8 week). 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 10 Aug 2016.