Adjunctive Laser for Periodontal Intrabony Defects

Study Overview
=================
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.

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

Conditions
-----------------
Periodontitis

Intervention / Treatment
-----------------
* Device: Er:YAG laser (Waterlase)
* Procedure: root surface dbridement


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: non-surgical periodontal therapy with or without laser adjunct
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laser<br>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)<br>* 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.<br>Procedure: root surface dbridement<br>* root surface debridement under local anaesthesia<br>|
| Placebo Comparator: Control<br>The other side of the mouth undergo root surface debridement using hand instruments and ultrasonic scaler alone | Procedure: root surface dbridement<br>* root surface debridement under local anaesthesia<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pocket resolution | Number of sites with absence of PPD >5mm following adjunctive laser treatment with RSD (= no need for surgery) | 12 months | 

Secondary Outcome Measures

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