Adjunctive Laser for Periodontal Intrabony Defects

Guy's and St Thomas' NHS Foundation Trust

Status: Unknown

Conditions: Periodontitis

Treatments: Procedure: root surface dbridement; Device: Er:YAG laser (Waterlase)

Study type: Interventional

Funder types: Other

Identifiers

NCT04847830

276918

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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28 participants in 2 patient groups, including a placebo group

Laser

Experimental group

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

Treatment:

Procedure: root surface dbridement

Device: Er:YAG laser (Waterlase)

Control

Placebo Comparator group

Description:

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

Treatment:

Procedure: root surface dbridement