Adjunctive Laser for Periodontal Intrabony Defects

Not Applicable

• Conditions: Periodontitis
• Interventions: Procedure: root surface dbridement

• Registration Number: NCT04847830
• Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust

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.

Study Timeline

• Status Verified: 2021-04
• Study Start: 2021-04
• Study First Submitted: 2021-04-01
• Study First Submitted QC: 2021-04-15
• Last Update Submitted: 2021-04-15
• Study First Posted: 2021-04-19
• Last Update Posted: 2021-04-19
• Primary Completion: 2023-06
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laser	root surface dbridement	One side of the mouth will undergo root surface debridement using hand instruments and ultrasonic scaler, with the addition of the Er:YAG laser
Control	root surface dbridement	The other side of the mouth undergo root surface debridement using hand instruments and ultrasonic scaler alone

Primary Outcome Measures

Name	Time	Method
Pocket resolution	12 months	Number of sites with absence of PPD \>5mm following adjunctive laser treatment with RSD (= no need for surgery)

Secondary Outcome Measures

Name	Time	Method
Recession	12 months	Changes in gingival recession measurement
Gain bone height	12 months	Radiographic improvement in bone levels
Patient-related outcomes	12 months	Questionnaire-based patient-reported outcomes
GCF biomarkers	12 months	Change in GCF concentration Biomarkers
CAL	12 months	Changes in clinical attachment level
Mobility	12 months	Changes in mobility scores