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Adjunctive Laser for Periodontal Intrabony Defects

Primary Purpose

Periodontitis

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Er:YAG laser (Waterlase)

root surface dbridement

About this trial

This is an interventional treatment trial for Periodontitis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Laser

Control

Arm Description

One side of the mouth will undergo root surface debridement using hand instruments and ultrasonic scaler, with the addition of the Er:YAG laser

The other side of the mouth undergo root surface debridement using hand instruments and ultrasonic scaler alone

Outcomes

Primary Outcome Measures

Pocket resolution

Number of sites with absence of PPD >5mm following adjunctive laser treatment with RSD (= no need for surgery)

Secondary Outcome Measures

Gain bone height

Radiographic improvement in bone levels

Patient-related outcomes

Questionnaire-based patient-reported outcomes

GCF biomarkers

Change in GCF concentration Biomarkers

Recession

Changes in gingival recession measurement

CAL

Changes in clinical attachment level

Mobility

Changes in mobility scores

Full Information

NCT ID

NCT04847830

First Posted

April 1, 2021

Last Updated

April 15, 2021

Sponsor

Guy's and St Thomas' NHS Foundation Trust

1. Study Identification

Unique Protocol Identification Number

NCT04847830

Brief Title

Adjunctive Laser for Periodontal Intrabony Defects

Official Title

Effects of Adjunctive Er, Cr :YSGG Laser Treatment to Nonsurgical Periodontal Treatment on Healing of Intrabony Periodontal Defects: a Randomised Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Unknown status

Study Start Date

April 2021 (Anticipated)

Primary Completion Date

June 2023 (Anticipated)

Study Completion Date

June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Guy's and St Thomas' NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Periodontitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

non-surgical periodontal therapy with or without laser adjunct

Masking

ParticipantInvestigatorOutcomes 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.

Allocation

Randomized

Enrollment

28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Laser

Arm Type

Experimental

Arm Description

One side of the mouth will undergo root surface debridement using hand instruments and ultrasonic scaler, with the addition of the Er:YAG laser

Arm Title

Control

Arm Type

Placebo Comparator

Arm Description

The other side of the mouth undergo root surface debridement using hand instruments and ultrasonic scaler alone

Intervention Type

Device

Intervention Name(s)

Er:YAG laser (Waterlase)

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

root surface dbridement

Intervention Description

root surface debridement under local anaesthesia

Primary Outcome Measure Information:

Title

Pocket resolution

Description

Number of sites with absence of PPD >5mm following adjunctive laser treatment with RSD (= no need for surgery)

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Gain bone height

Description

Radiographic improvement in bone levels

Time Frame

12 months

Title

Patient-related outcomes

Description

Questionnaire-based patient-reported outcomes

Time Frame

12 months

Title

GCF biomarkers

Description

Change in GCF concentration Biomarkers

Time Frame

12 months

Title

Recession

Description

Changes in gingival recession measurement

Time Frame

12 months

Title

CAL

Description

Changes in clinical attachment level

Time Frame

12 months

Title

Mobility

Description

Changes in mobility scores

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Luigi Nibali

Phone

0044 2071887188

luigi.nibali@kcl.ac.uk

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Adjunctive Laser for Periodontal Intrabony Defects

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