Adjunctive Laser for Periodontal Intrabony Defects

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04847830
• Other study ID #: 276918
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2021
• Est. completion date: June 2023

Study information

• Verified date: April 2021
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: Luigi Nibali
• Phone: 0044 2071887188
• Email: luigi.nibali[@]kcl.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 28
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Periodontitis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pocket resolution	Number of sites with absence of PPD >5mm following adjunctive laser treatment with RSD (= no need for surgery)	12 months
Secondary	Gain bone height	Radiographic improvement in bone levels	12 months
Secondary	Patient-related outcomes	Questionnaire-based patient-reported outcomes	12 months
Secondary	GCF biomarkers	Change in GCF concentration Biomarkers	12 months
Secondary	Recession	Changes in gingival recession measurement	12 months
Secondary	CAL	Changes in clinical attachment level	12 months
Secondary	Mobility	Changes in mobility scores	12 months