Treatment of Periodontitis Using Er:YAG Laser vs. Conventional Treatment Modalities

Study Overview
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Brief Summary
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Conventional non-surgical periodontal treatment, that is, root debridement using manual and ultrasonic means at baseline and surgery using the same means after 6 months in case of persistent deep pockets (Group 1)/ Er:YAG laser used in a non-surgical approach at baseline and surgery using the same laser after 6 months in case of persistent deep pockets (Group 2)/ Surgery at baseline using manual and ultrasonic means (Group 3). All patients will undergo supragingival maintenance on a yearly basis.

Official Title
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Randomized Controlled Trial to Evaluate the Efficacy of Er:YAG Laser and Surgical Therapy in Treatment of Chronic Periodontitis

Conditions
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Chronic Periodontitis

Intervention / Treatment
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* Procedure: Er: YAG Laser
* Procedure: Conventional treatment 1(ultrasonic and manual means)
* Procedure: Conventional treatment 2 (ultrasonic and manual means)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: at least 35 years of age at least 18 teeth present that can be retained by means of therapy among which 4 multirooted teeth or more(wisdom teeth excluded) presence of at least one deep pocket per quadrant (6 mm PPD or more) with radiographic evidence of bone loss (>= 30% of root length) Exclusion Criteria: pregnancy removable prosthesis

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Scaling and root planing at baseline and surgery for remaining deep pockets after 6 months both using Er:YAG laser | Procedure: Er: YAG Laser<br>* Scaling and root planing at baseline and surgery for remaining deep pockets after 6 months both using Er:YAG laser<br>|
| Active Comparator: 2<br>Scaling and root planing at baseline and surgery for remaining deep pockets after 6 months both using conventional methods (ultrasonic and manual means) | Procedure: Conventional treatment 1(ultrasonic and manual means)<br>* Scaling and root planing at baseline and surgery for remaining deep pockets after 6 months both using conventional methods : ultrasonic and manual means<br>|
| Active Comparator: 3<br>Surgery at baseline for all deep pockets using conventional methods (ultrasonic and manual means) | Procedure: Conventional treatment 2 (ultrasonic and manual means)<br>* Surgery at baseline for all deep pockets using conventional methods: ultrasonic and manual means<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probing pocket depth, Clinical attachment level and microbiological analysis |  | At baseline, 3, 6, 12, 24, 36, 48 and 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gingivitis index, plaque index, bleeding on probing at the same time intervals + the number of interventions |  | After 5 years | 
| Consumed time per treatment/ Patient satisfaction/comfort ( Oral Health impact Profile : OHIP )/ The estimated financial costs based on average data delivered for instance by the Belgian Society of Periodontology |  | After 5 years | 
| Adverse effects described by the patient (number of painkillers taken, visual analogue scale to monitor post-operative pain, tooth sensitivity) |  | After 5 years |