Chronic PeriodontitisNCT00669253
Treatment of Periodontitis Using Er:YAG Laser vs. Conventional Treatment Modalities
A study testing Er: YAG Laser, Conventional treatment 1(ultrasonic and manual means) and Conventional treatment 2 (ultrasonic and manual means) in people with Chronic Periodontitis, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Conventional non-surgical periodontal treatment, that is, root debridement using manual and ultrasonic means at baseline and surgery using the same means after 6 months in case of persistent deep pockets (Group 1)/ Er:YAG laser used in a non-surgical approach at baseline and surgery using the same laser after 6 months… Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- Er: YAG Laser, Conventional treatment 1(ultrasonic and manual means) and Conventional treatment 2 (ultrasonic and manual means)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2008to Dec 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least 35 years of age
- at least 18 teeth present that can be retained by means of therapy among which 4 multirooted teeth or more(wisdom teeth excluded)
- presence of at least one deep pocket per quadrant (6 mm PPD or more) with radiographic evidence of bone loss (>= 30% of root length)
Who cannot join
- pregnancy
- removable prosthesis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial to Evaluate the Efficacy of Er:YAG Laser and Surgical Therapy in Treatment of Chronic Periodontitis
Conventional non-surgical periodontal treatment, that is, root debridement using manual and ultrasonic means at baseline and surgery using the same means after 6 months in case of persistent deep pockets (Group 1)/ Er:YAG laser used in a non-surgical approach at baseline and surgery using the same laser after 6 months in case of persistent deep pockets (Group 2)/ Surgery at baseline using manual and ultrasonic means (Group 3). All patients will undergo supragingival maintenance on a yearly basis.
- Conditions
- Chronic Periodontitis
- Being tested
- Er: YAG Laser, Conventional treatment 1(ultrasonic and manual means), Conventional treatment 2 (ultrasonic and manual means)
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Er: YAG LaserProcedure or surgery
Scaling and root planing at baseline and surgery for remaining deep pockets after 6 months both using Er:YAG laser
Conventional treatment 1(ultrasonic and manual means)Procedure or surgery
Scaling and root planing at baseline and surgery for remaining deep pockets after 6 months both using conventional methods : ultrasonic and manual means
Conventional treatment 2 (ultrasonic and manual means)Procedure or surgery
Surgery at baseline for all deep pockets using conventional methods: ultrasonic and manual means
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Scaling and root planing at baseline and surgery for remaining deep pockets after 6 months both using Er:YAG laser Receives: Procedure: Er: YAG Laser |
| 2 | Active comparator | Scaling and root planing at baseline and surgery for remaining deep pockets after 6 months both using conventional methods (ultrasonic and manual means) Receives: Procedure: Conventional treatment 1(ultrasonic and manual means) |
| 3 | Active comparator | Surgery at baseline for all deep pockets using conventional methods (ultrasonic and manual means) Receives: Procedure: Conventional treatment 2 (ultrasonic and manual means) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing pocket depth, Clinical attachment level and microbiological analysis
Measured: At baseline, 3, 6, 12, 24, 36, 48 and 60 months
Secondary outcomes (3)
Gingivitis index, plaque index, bleeding on probing at the same time intervals + the number of interventions
Measured: After 5 years
Consumed time per treatment/ Patient satisfaction/comfort ( Oral Health impact Profile : OHIP )/ The estimated financial costs based on average data delivered for instance by the Belgian Society of Periodontology
Measured: After 5 years
Adverse effects described by the patient (number of painkillers taken, visual analogue scale to monitor post-operative pain, tooth sensitivity)
Measured: After 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2008 (estimated)
- Study startJun 2008
- Primary completionDec 2010
- Study completionDec 2012
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 University Hospital, GhentThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hugo De Bruyn, MD, Phd, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00669253
- Sponsor's protocol ID
- 2008/189
- Status last verified
- Dec 2014
- First submitted
- 25 Apr 2008
- Last updated
- 5 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial to Evaluate the Efficacy of Er:YAG Laser and Surgical Therapy in Treatment of Chronic Periodontitis
- ClinicalTrials.gov ID
- NCT00669253
- Acronym / sponsor ID
- 2008/189
- Conditions
- Chronic Periodontitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 30 Apr 2008 (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.
Conventional non-surgical periodontal treatment, that is, root debridement using manual and ultrasonic means at baseline and surgery using the same means after 6 months in case of persistent deep pockets (Group 1)/ Er:YAG laser used in a non-surgical approach at baseline and surgery using the same laser after 6 months in case of persistent deep pockets (Group 2)/ Surgery at baseline using manual and ultrasonic means (Group 3). All patients will undergo supragingival maintenance on a yearly basis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Er: YAG LaserScaling and root planing at baseline and surgery for remaining deep pockets after 6 months both using Er:YAG laser |
| 2 | Active comparator | Procedure: Conventional treatment 1(ultrasonic and manual means)Scaling and root planing at baseline and surgery for remaining deep pockets after 6 months both using conventional methods (ultrasonic and manual means) |
| 3 | Active comparator | Procedure: Conventional treatment 2 (ultrasonic and manual means)Surgery at baseline for all deep pockets using conventional methods (ultrasonic and manual means) |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- at least 35 years of age
- at least 18 teeth present that can be retained by means of therapy among which 4 multirooted teeth or more(wisdom teeth excluded)
- presence of at least one deep pocket per quadrant (6 mm PPD or more) with radiographic evidence of bone loss (>= 30% of root length)
Key exclusion criteria (2 listed)
- pregnancy
- removable prosthesis
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 |
|---|---|---|
| Er: YAG LaserScaling and root planing at baseline and surgery for remaining deep pockets after 6 months both using Er:YAG laser | Procedure or surgery | 1 |
| Conventional treatment 1(ultrasonic and manual means)Scaling and root planing at baseline and surgery for remaining deep pockets after 6 months both using conventional methods : ultrasonic and manual means | Procedure or surgery | 2 |
| Conventional treatment 2 (ultrasonic and manual means)Surgery at baseline for all deep pockets using conventional methods: ultrasonic and manual means | Procedure or surgery | 3 |
Primary outcome
Probing pocket depth, Clinical attachment level and microbiological analysis
Time frame: At baseline, 3, 6, 12, 24, 36, 48 and 60 months
3 secondary outcomes
Gingivitis index, plaque index, bleeding on probing at the same time intervals + the number of interventions
Time frame: After 5 years
Consumed time per treatment/ Patient satisfaction/comfort ( Oral Health impact Profile : OHIP )/ The estimated financial costs based on average data delivered for instance by the Belgian Society of Periodontology
Time frame: After 5 years
Adverse effects described by the patient (number of painkillers taken, visual analogue scale to monitor post-operative pain, tooth sensitivity)
Time frame: After 5 years
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 5 Dec 2014.
- Related InfoLink provided by the sponsor.
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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.
Hugo De Bruyn, MD, Phd principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Er: YAG Laser, Conventional treatment 1(ultrasonic and manual means) and Conventional treatment 2 (ultrasonic and manual means) in people with Chronic Periodontitis, run by University Hospital, Ghent at 1 site in Belgium.
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 2 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 5 Dec 2014. 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 Belgium. 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 pocket depth, Clinical attachment level and microbiological analysis (time frame: At baseline, 3, 6, 12, 24, 36, 48 and 60 months). 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 5 Dec 2014.