PeriodontitisNCT04847830
Adjunctive Laser for Periodontal Intrabony Defects
A study testing Er:YAG laser (Waterlase) and root surface dbridement in people with Periodontitis, run by Guy's and St Thomas' NHS Foundation Trust.
Trial summary
Participants with periodontitis and presence of bilateral intrabony defect will be randomised to have one side of the mouth undergo root surface debridement using hand instruments and ultrasonic scaler alone, while the contralateral side will receive the same treatment, with the addition of the Er:YAG laser. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Periodontitis
- What is being tested?
- Er:YAG laser (Waterlase) and root surface dbridement
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- Apr 2021to Jun 2023
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Minimum of 20 teeth. Diagnosis of Severe Periodontitis (Diagnosis of Periodontitis stage III or IV (grade A, B or C) (Tonetti et al. 2018)
- Presence of at least 2 teeth with ≥ 6 mm pockets and minimum of 3 mm intrabony defect, in opposing quadrants of the upper or lower arch.
- Minimum of 20 teeth. Diagnosis of Severe Periodontitis (Diagnosis of Periodontitis stage III or IV (grade A, B or C) (Tonetti et al. 2018)
- Presence of at least 2 teeth with ≥ 6 mm pockets and minimum of 3 mm intrabony defect, in opposing quadrants of the upper or lower arch.
Who cannot join
- Wearing of a removable appliance/denture
- Wearing of orthodontic appliances.
- Current smoking - any history of smoking or vaping within last 5 years
- Relevant medical history likely to affect periodontal disease or taking relevant medication, including diabetes, as judged by the examining clinician
- Periodontal treatment (surgical/non-surgical root surface debridement under local anaesthesia) within last 12 months, as judged by the examining clinician
- History of any antibiotic use within last 3 months.
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- Pregnant patients
- Teeth with hopeless prognosis indicated for extraction (Cortellini et al 2011)
- Patients with a non-adequate level of English
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effects of Adjunctive Er, Cr :YSGG Laser Treatment to Nonsurgical Periodontal Treatment on Healing of Intrabony Periodontal Defects: a Randomised Controlled Trial
Participants with periodontitis and presence of bilateral intrabony defect will be randomised to have one side of the mouth undergo root surface debridement using hand instruments and ultrasonic scaler alone, while the contralateral side will receive the same treatment, with the addition of the Er:YAG laser. Outcomes studies will be periodontal clinical parameters at 3 months, 6 months, 9 months and 12 months after treatment, radiographic parameters at 12 months, patient-reported parameters and laboratory analyses.
Read the detailed description
The study is a Double-masked randomised controlled trial with split-mouth design.
Participants with periodontitis will be randomised to have one side of the mouth undergo root surface debridement using hand instruments and ultrasonic scaler alone, while the contralateral side will receive the same treatment, with the addition of the Er:YAG laser. Outcomes studies will be periodontal clinical parameters at 3 months, 6 months, 9 months and 12 months after treatment, radiographic parameters at 12 months, patient-reported parameters and laboratory analyses.
- Conditions
- Periodontitis
- Being tested
- Er:YAG laser (Waterlase), root surface dbridement
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Er:YAG laser (Waterlase)Device
The WaterLase iPlus tissue cutting system is a unique device with diverse, hard- and soft-tissue dental applications. It utilizes advanced laser and water atomization technologies to safely and effectively cut, shave, contour, roughen, etch, and resect oral hard-tissue, and direct laser energy to perform oral soft-tissue removal, incision, excision, ablation and coagulation.
root surface dbridementProcedure or surgery
root surface debridement under local anaesthesia
| Study group | Role | What they receive |
|---|---|---|
| Laser | Experimental | One side of the mouth will undergo root surface debridement using hand instruments and ultrasonic scaler, with the addition of the Er:YAG laser Receives: Device: Er:YAG laser (Waterlase); Procedure: root surface dbridement |
| Control | Placebo comparator | The other side of the mouth undergo root surface debridement using hand instruments and ultrasonic scaler alone Receives: Procedure: root surface dbridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pocket resolution
Number of sites with absence of PPD >5mm following adjunctive laser treatment with RSD (= no need for surgery)
Measured: 12 months
Secondary outcomes (6)
Gain bone height
Radiographic improvement in bone levels
Measured: 12 months
Patient-related outcomes
Questionnaire-based patient-reported outcomes
Measured: 12 months
GCF biomarkers
Change in GCF concentration Biomarkers
Measured: 12 months
Recession
Changes in gingival recession measurement
Measured: 12 months
CAL
Changes in clinical attachment level
Measured: 12 months
Mobility
Changes in mobility scores
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study startApr 2021 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
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.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe 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
- Model description
- non-surgical periodontal therapy with or without laser adjunct
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04847830
- Sponsor's protocol ID
- 276918
- Status last verified
- Apr 2021
- First submitted
- 1 Apr 2021
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Adjunctive Er, Cr :YSGG Laser Treatment to Nonsurgical Periodontal Treatment on Healing of Intrabony Periodontal Defects: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04847830
- Acronym / sponsor ID
- 276918
- Conditions
- Periodontitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- Apr 2021 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 19 Apr 2021 (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.
Participants with periodontitis and presence of bilateral intrabony defect will be randomised to have one side of the mouth undergo root surface debridement using hand instruments and ultrasonic scaler alone, while the contralateral side will receive the same treatment, with the addition of the Er:YAG laser. Outcomes studies will be periodontal clinical parameters at 3 months, 6 months, 9 months and 12 months after treatment, radiographic parameters at 12 months, patient-reported parameters and laboratory analyses.
Detailed description
The study is a Double-masked randomised controlled trial with split-mouth design.
Participants with periodontitis will be randomised to have one side of the mouth undergo root surface debridement using hand instruments and ultrasonic scaler alone, while the contralateral side will receive the same treatment, with the addition of the Er:YAG laser. Outcomes studies will be periodontal clinical parameters at 3 months, 6 months, 9 months and 12 months after treatment, radiographic parameters at 12 months, patient-reported parameters and laboratory analyses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- non-surgical periodontal therapy with or without laser adjunct
| Arm | Type | Receives |
|---|---|---|
| Laser | Experimental | Device: Er:YAG laser (Waterlase), Procedure: root surface dbridementOne side of the mouth will undergo root surface debridement using hand instruments and ultrasonic scaler, with the addition of the Er:YAG laser |
| Control | Placebo comparator | Procedure: root surface dbridementThe other side of the mouth undergo root surface debridement using hand instruments and ultrasonic scaler alone |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Minimum of 20 teeth. Diagnosis of Severe Periodontitis (Diagnosis of Periodontitis stage III or IV (grade A, B or C) (Tonetti et al. 2018)
- Presence of at least 2 teeth with ≥ 6 mm pockets and minimum of 3 mm intrabony defect, in opposing quadrants of the upper or lower arch.
- Minimum of 20 teeth. Diagnosis of Severe Periodontitis (Diagnosis of Periodontitis stage III or IV (grade A, B or C) (Tonetti et al. 2018)
- Presence of at least 2 teeth with ≥ 6 mm pockets and minimum of 3 mm intrabony defect, in opposing quadrants of the upper or lower arch.
Key exclusion criteria (9 listed)
- Wearing of a removable appliance/denture
- Wearing of orthodontic appliances.
- Current smoking - any history of smoking or vaping within last 5 years
- Relevant medical history likely to affect periodontal disease or taking relevant medication, including diabetes, as judged by the examining clinician
- Periodontal treatment (surgical/non-surgical root surface debridement under local anaesthesia) within last 12 months, as judged by the examining clinician
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 laser (Waterlase)The WaterLase iPlus tissue cutting system is a unique device with diverse, hard- and soft-tissue dental applications. It utilizes advanced laser and water atomization technologies to safely and effectively cut, shave, contour, roughen, etch, and resect oral hard-tissue, and direct laser energy to perform oral soft-tissue removal, incision, excision, ablation and coagulation. | Device | Laser |
| root surface dbridementroot surface debridement under local anaesthesia | Procedure or surgery | Control, Laser |
Primary outcome
Pocket resolution
Time frame: 12 months
Number of sites with absence of PPD >5mm following adjunctive laser treatment with RSD (= no need for surgery)
6 secondary outcomes
Gain bone height
Time frame: 12 months
Patient-related outcomes
Time frame: 12 months
GCF biomarkers
Time frame: 12 months
Recession
Time frame: 12 months
CAL
Time frame: 12 months
Mobility
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Er:YAG laser (Waterlase) and root surface dbridement in people with Periodontitis, run by Guy's and St Thomas' NHS Foundation Trust.
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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 19 Apr 2021. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luigi Nibali (0044 2071887188, luigi.nibali@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pocket resolution (time frame: 12 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 19 Apr 2021.