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Adjunctive Laser for Periodontal Intrabony Defects

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ClinicalTrials.gov Identifier: NCT04847830
Recruitment Status : Not yet recruiting
First Posted : April 19, 2021
Last Update Posted : April 19, 2021
Sponsor:
Information provided by (Responsible Party):
Guy's and St Thomas' NHS Foundation Trust

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment Phase
Periodontitis Device: Er:YAG laser (Waterlase) Procedure: root surface dbridement Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: non-surgical periodontal therapy with or without laser adjunct
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Randomisation for the site receiving the additional test procedure (laser) will be carried out between baseline and visit 2. The randomisation will be carried out by Postgraduate Students independent of the study. Random permuted block sizes of 4 will be employed. The centralised randomisation service 'Sealed envelope' will be used for randomisation and to ensure allocation concealment. A sealed envelope will be enclosed with the patient's notes by personnel not directly involved in the study. The therapist will only be informed about treatment allocation by opening the envelope following completion of non-surgical therapy (when the laser will need to be employed on the test site). No minimization or stratification is planned. The randomisation code will only be revealed after statistical analysis. The randomisation will be done by a different postgraduate student who will be masked and is not involved in the study.
Primary Purpose: Treatment
Official Title: Effects of Adjunctive Er, Cr :YSGG Laser Treatment to Nonsurgical Periodontal Treatment on Healing of Intrabony Periodontal Defects: a Randomised Controlled Trial
Estimated Study Start Date : April 2021
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023
Arms and Interventions
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Arm Intervention/treatment
Experimental: Laser
One side of the mouth will undergo root surface debridement using hand instruments and ultrasonic scaler, with the addition of the Er:YAG laser
 Device: 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.

Procedure: root surface dbridement
root surface debridement under local anaesthesia
Placebo Comparator: Control
The other side of the mouth undergo root surface debridement using hand instruments and ultrasonic scaler alone
 Procedure: root surface dbridement
root surface debridement under local anaesthesia


Outcome Measures
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Primary Outcome Measures :
  1. Pocket resolution [ Time Frame: 12 months ]
    Number of sites with absence of PPD >5mm following adjunctive laser treatment with RSD (= no need for surgery)


Secondary Outcome Measures :
  1. Gain bone height [ Time Frame: 12 months ]
    Radiographic improvement in bone levels

  2. Patient-related outcomes [ Time Frame: 12 months ]
    Questionnaire-based patient-reported outcomes

  3. GCF biomarkers [ Time Frame: 12 months ]
    Change in GCF concentration Biomarkers

  4. Recession [ Time Frame: 12 months ]
    Changes in gingival recession measurement

  5. CAL [ Time Frame: 12 months ]
    Changes in clinical attachment level

  6. Mobility [ Time Frame: 12 months ]
    Changes in mobility scores


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Inclusion:

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.

Exclusion:

  • 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.
  • Pregnant patients
  • Teeth with hopeless prognosis indicated for extraction (Cortellini et al 2011)
  • Patients with a non-adequate level of English
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04847830


Contacts
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Contact: Luigi Nibali 0044 2071887188 luigi.nibali@kcl.ac.uk

Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
More Information
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Responsible Party: Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04847830    
Other Study ID Numbers: 276918
First Posted: April 19, 2021    Key Record Dates
Last Update Posted: April 19, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases