PeriodontitisNCT04061460
Periodontal Treatment in Non Smokers, Former Smokers and Smokers
A study of Periodontitis, run by University of Liege.
Trial summary
The present study was designed as a prospective controlled study focusing on the effect of oral hygiene instructions and periodontal nonsurgical treatment( PNST) on clinical outcomes and patients related outcomes (PROMs) in smokers versus former smokers versus non smoker patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontitis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2014to 1 Jul 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged of minimum 18 years old
- chronic periodontitis
- presence of a minimum of 6 teeth at each arch
- a minimum of 6 teeth with pocket depth of 5 mm
- signed the informed consent
Who cannot join
- aggressive periodontitis
- diabetes
- connective tissue disease
- pregnancy
- radio-therapy
- chemotherapy
- psychological disease
- previous periodontal therapy
About this study
Official title: Respective Effects of Periodontal Oral Hygiene Instructions and Non-surgical Treatment on Clinical and Patient Related Outcomes: a Controlled Study in Non Smoker, Former Smoker and Smoker
The present study was designed as a prospective controlled study focusing on the effect of oral hygiene instructions and periodontal nonsurgical treatment( PNST) on clinical outcomes and patients related outcomes (PROMs) in smokers versus former smokers versus non smoker patients.
Read the detailed description
75 consecutive patients presenting chronic periodontitis and who needed periodontal treatment were recruited in the Department of Periodontology and Oral Surgery at the University Hospital of Liège, Belgium (CHU, Sart-Tilman) according to the inclusion criteria.
The patients were subdivided between three groups: non-smoker (25), former smoker (25), and smoker patients(25).
Patients received informations about periodontitis genesis, the demonstration of oral hygiene instructions (OHI), the goal of PNST and the follow-up time were given ( baseline, after OHI, 3 months after PNST).
Periodontal clinical parameters and PROMS were collecetd and compared between 3 groups, at each visit.
Data collection:Periodontal clinical measurements and PROMS
The periodontal examination was conducted by a single periodontist (L.S) and included: probing depth (PD), gingival recession (RD), clinical attachment level (CAL), bleeding on probing (BOP), plaque score index (PI), Furcation (Furc), tooth mobility , the percentage of sites of PD ≥ 6mm and the number of missing tooth was recorded A graduated manual periodontal probe was used to take measurements at the 6 sites of each tooth. BOP (%) and plaque score (%) were collected as well as tooth mobility with a score from 1 to 3 . The furcation impairments were diagnosed with a Nabers probe according to the classification of Hamp and the Inflamed Surface Area (PISA) was calculated. Patients were classified according to the new periodontal classification identifying the grade, the stage and the extend of the periodontitis.
Patient-reported outcome measures (PROMs) A questionnaire using a visual analogue scale (VAS) was given to all participants regarding their oral hygiene habits, and perception about oral esthetic. The following questions were subjected to the patients: nine questions graduated scale from 0 to 10: 1/"How do you judge your degree of oral hygiene?", 2/"What is the frequency of utilization of interdental brushing?", 3/"Do you like the color of your teeth? , 4/"Your teeth are there sensitive to cold? , 5/ "How do you judge your degree of gingival health? , 6/ "How do you judge the esthetic aspect of you gum?", 7/ "Do you like the color of your gum? ", 8/ "Does your gum bleed during brushing?", 9/ "How do you judge your breath?".
sample size: The study was powered to detect a minimum clinically significant difference in probing depth (PD) of 0.5 mm between patients, using α= 0.05. The probing depth at baseline was considered covariate.
- Conditions
- Periodontitis
- Being tested
- mechanical plaque control
- Keywords
- smoking, oral hygiene
- Medical subject headings
- Periodontitis, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mechanical plaque controlProcedure or surgery
supra and sub gingival debridment ( plaque control)
| Study group | Role | What they receive |
|---|---|---|
| non smokers | Other | patient who never smoked Receives: Procedure: mechanical plaque control |
| former smoker | Other | patient who smoked in the past Receives: Procedure: mechanical plaque control |
| smoker | Other | patient who still smoke Receives: Procedure: mechanical plaque control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of probing depth (PD)
PD was measured , in millimetern with periodontal probe, at 6 sites of each tooth
Measured: 2 weeks after baseline and 3 month after PNST
Secondary outcomes (1)
Change from baseline of BOP (bleeding on probing)
BOP was measured , in percentage of bleeding, at 6 sites of each tooth
Measured: 2 weeks after baseline and 3 month after PNST
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2019
- Study start1 Sep 2014
- Primary completion1 Jul 2015
- Study completion1 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- at baseline, patients recieved oral hygiene instructions The same examiner (LS) performed an oral demonstration including teeth brushing, interdental cleaning and tong wash. Each patient received proper head and interdental brushes demonstration, moreover, patients were educated to brush their ventral face of their tong A single periodontist (L.S) performed the supra gingival debridment at the second appointment (2 weeks after receiving OHI) , followed 2 weeks after by a full month debridement using ultrason piezoelectric device (Newtron P5 XS Bled, Acteon, Satelec , France) with specific micro-inserts (H1, H3, H4L, H4R)
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leila Salhi, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04061460
- Sponsor's protocol ID
- B707201421977
- Status last verified
- Aug 2019
- First submitted
- 14 Aug 2019
- Last updated
- 22 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respective Effects of Periodontal Oral Hygiene Instructions and Non-surgical Treatment on Clinical and Patient Related Outcomes: a Controlled Study in Non Smoker, Former Smoker and Smoker
- ClinicalTrials.gov ID
- NCT04061460
- Acronym / sponsor ID
- B707201421977
- Conditions
- Periodontitis
- Keywords
- smoking, oral hygiene
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 1 Sep 2014 (actual)
- Primary completion
- 1 Jul 2015 (actual)
- Study completion
- 1 Jul 2016 (actual)
- First posted
- 19 Aug 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.
The present study was designed as a prospective controlled study focusing on the effect of oral hygiene instructions and periodontal nonsurgical treatment( PNST) on clinical outcomes and patients related outcomes (PROMs) in smokers versus former smokers versus non smoker patients.
Detailed description
75 consecutive patients presenting chronic periodontitis and who needed periodontal treatment were recruited in the Department of Periodontology and Oral Surgery at the University Hospital of Liège, Belgium (CHU, Sart-Tilman) according to the inclusion criteria.
The patients were subdivided between three groups: non-smoker (25), former smoker (25), and smoker patients(25).
Patients received informations about periodontitis genesis, the demonstration of oral hygiene instructions (OHI), the goal of PNST and the follow-up time were given ( baseline, after OHI, 3 months after PNST).
Periodontal clinical parameters and PROMS were collecetd and compared between 3 groups, at each visit.
Data collection:Periodontal clinical measurements and PROMS
The periodontal examination was conducted by a single periodontist (L.S) and included: probing depth (PD), gingival recession (RD), clinical attachment level (CAL), bleeding on probing (BOP), plaque score index (PI), Furcation (Furc), tooth mobility , the percentage of sites of PD ≥ 6mm and the number of missing tooth was recorded A graduated manual periodontal probe was used to take measurements at the 6 sites of each tooth. BOP (%) and plaque score (%) were collected as well as tooth mobility with a score from 1 to 3 . The furcation impairments were diagnosed with a Nabers probe according to the classification of Hamp and the Inflamed Surface Area (PISA) was calculated. Patients were classified according to the new periodontal classification identifying the grade, the stage and the extend of the periodontitis.
Patient-reported outcome measures (PROMs) A questionnaire using a visual analogue scale (VAS) was given to all participants regarding their oral hygiene habits, and perception about oral esthetic. The following questions were subjected to the patients: nine questions graduated scale from 0 to 10: 1/"How do you judge your degree of oral hygiene?", 2/"What is the frequency of utilization of interdental brushing?", 3/"Do you like the color of your teeth? , 4/"Your teeth are there sensitive to cold? , 5/ "How do you judge your degree of gingival health? , 6/ "How do you judge the esthetic aspect of you gum?", 7/ "Do you like the color of your gum? ", 8/ "Does your gum bleed during brushing?", 9/ "How do you judge your breath?".
sample size: The study was powered to detect a minimum clinically significant difference in probing depth (PD) of 0.5 mm between patients, using α= 0.05. The probing depth at baseline was considered covariate.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- at baseline, patients recieved oral hygiene instructions The same examiner (LS) performed an oral demonstration including teeth brushing, interdental cleaning and tong wash. Each patient received proper head and interdental brushes demonstration, moreover, patients were educated to brush their ventral face of their tong A single periodontist (L.S) performed the supra gingival debridment at the second appointment (2 weeks after receiving OHI) , followed 2 weeks after by a full month debridement using ultrason piezoelectric device (Newtron P5 XS Bled, Acteon, Satelec , France) with specific micro-inserts (H1, H3, H4L, H4R)
| Arm | Type | Receives |
|---|---|---|
| non smokers | Other | Procedure: mechanical plaque controlpatient who never smoked |
| former smoker | Other | Procedure: mechanical plaque controlpatient who smoked in the past |
| smoker | Other | Procedure: mechanical plaque controlpatient who still smoke |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- aged of minimum 18 years old
- chronic periodontitis
- presence of a minimum of 6 teeth at each arch
- a minimum of 6 teeth with pocket depth of 5 mm
- signed the informed consent
Key exclusion criteria (8 listed)
- aggressive periodontitis
- diabetes
- connective tissue disease
- pregnancy
- radio-therapy
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 |
|---|---|---|
| mechanical plaque controlsupra and sub gingival debridment ( plaque control) | Procedure or surgery | former smoker, non smokers, smoker |
Primary outcome
Change from baseline of probing depth (PD)
Time frame: 2 weeks after baseline and 3 month after PNST
PD was measured , in millimetern with periodontal probe, at 6 sites of each tooth
1 secondary outcome
Change from baseline of BOP (bleeding on probing)
Time frame: 2 weeks after baseline and 3 month after PNST
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 22 Aug 2019.
- Individual participant dataSharing planned: Undecided
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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 of Periodontitis, run by University of Liege.
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 5 inclusion and 8 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 22 Aug 2019. 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?
Change from baseline of probing depth (PD) (time frame: 2 weeks after baseline and 3 month after PNST). 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 22 Aug 2019.