Combined Er:YAG And Nd:YAG Laser Protocol For Treatment Of Peri-Implantitis
Primary Purpose
Peri-Implantitis
Status
Recruiting
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Lightwalker Laser (Fotona)
standard
Sponsored by
About this trial
This is an interventional treatment trial for Peri-Implantitis focused on measuring laser, Er:YAG, Nd:YAG, periimplantitis, randomized controlled trial
Eligibility Criteria
Inclusion Criteria:
- at least one implant with peri-implantitis
- no serious mobility of the implants
- written informed consent of the voluntary participant in the study
- availability of participant for control visits for a follow-up of at least 12 months without interruptions
Exclusion Criteria:
- serious systematic disease
- pregnancy
- current use of photosensitive drugs, bisphosphonate medication or antibiotics
- patients who do not want to follow post treatment recommendation of oral hygiene and follow-up visits
Sites / Locations
- Instituto Universitário de Ciências da Saude, CESPURecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Laser
Control
Arm Description
For the laser group we will use a Lightwalker Laser (Fotona) with a Er:YAG 2940 nm and Nd:YAG 1064 nm wavelengths units.
Standard periimplantitis treatment will be conducted in the control group.
Outcomes
Primary Outcome Measures
Proportion of participants with treatment success
Treatment success defined as implant survival with the absence of peri-implant probing depths (PD) greater than 5 mm with concomitant bleeding/suppuration and absence of progression of peri-implant bone loss.
Secondary Outcome Measures
Plaque index
(PI)
Plaque index
(PI)
Plaque index
(PI)
Plaque index
(PI)
Bleeding on probing
(BOP) evaluated as present if bleeding was evident within 30 s after probing, or absent, if no bleeding was noticed within 30 s after probing.
Bleeding on probing
evaluated as present if bleeding was evident within 30 s after probing, or absent, if no bleeding was noticed within 30 s after probing.
Bleeding on probing
evaluated as present if bleeding was evident within 30 s after probing, or absent, if no bleeding was noticed within 30 s after probing.
Bleeding on probing
evaluated as present if bleeding was evident within 30 s after probing, or absent, if no bleeding was noticed within 30 s after probing.
Probing depth
measured from the mucosal margin to the bottom of the pocket.
Probing depth
measured from the mucosal margin to the bottom of the pocket.
Probing depth
measured from the mucosal margin to the bottom of the pocket.
Probing depth
measured from the mucosal margin to the bottom of the pocket.
Mucosal recession
measured from the mucosal margin to the bottom of the pocket.
Mucosal recession
measured from the mucosal margin to the bottom of the pocket.
Mucosal recession
measured from the mucosal margin to the bottom of the pocket.
Mucosal recession
measured from the mucosal margin to the bottom of the pocket.
Clinical attachment level gain
Difference in clinical attachment level at baseline and follow up.
Clinical attachment level gain
Difference in clinical attachment level at baseline and follow up.
Clinical attachment level gain
Difference in clinical attachment level at baseline and follow up.
Clinical attachment level gain
Difference in clinical attachment level at baseline and follow up.
Quality of life questionnaire
Oral Health Impact Profile-14 on the scale from 0 to 56 with higher scores indicating a poorer oral health-related quality of life.
Quality of life questionnaire
Oral Health Impact Profile-14 on the scale from 0 to 56 with higher scores indicating a poorer oral health-related quality of life.
Quality of life questionnaire
Oral Health Impact Profile-14 on the scale from 0 to 56 with higher scores indicating a poorer oral health-related quality of life.
Quality of life questionnaire
Oral Health Impact Profile-14 on the scale from 0 to 56 with higher scores indicating a poorer oral health-related quality of life.
Quality of life questionnaire
Oral Health Impact Profile-14 on the scale from 0 to 56 with higher scores indicating a poorer oral health-related quality of life.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03819075
Brief Title
Combined Er:YAG And Nd:YAG Laser Protocol For Treatment Of Peri-Implantitis
Official Title
An Evaluation Of Effectiveness Of A Combined Er:YAG And Nd:YAG Laser Protocol For Treatment Of Peri-Implantitis: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 3, 2018 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
May 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Luis Monteiro
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A laser treatment for periimplantitis using two different wavelengths (Er:YAG and Nd:YAG) will be compared to standard treatment in a randomized clinical trial.
Detailed Description
The general aim of this study is to evaluate the clinical outcome of the treatment of peri-implantitis using a combination of a Er:YAG and Nd:YAG laser protocol or using a conventional mechanical treatment in patients with a diagnosis of peri-implantitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-Implantitis
Keywords
laser, Er:YAG, Nd:YAG, periimplantitis, randomized controlled trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups; laser and control
Masking
Outcomes Assessor
Masking Description
Clinical measurements will be performed by an evaluator unaware of group assignment.
Allocation
Randomized
Enrollment
62 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Laser
Arm Type
Experimental
Arm Description
For the laser group we will use a Lightwalker Laser (Fotona) with a Er:YAG 2940 nm and Nd:YAG 1064 nm wavelengths units.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Standard periimplantitis treatment will be conducted in the control group.
Intervention Type
Device
Intervention Name(s)
Lightwalker Laser (Fotona)
Other Intervention Name(s)
TwinLight periimplantitis
Intervention Description
For the laser group we will use a Lightwalker Laser (Fotona) with a Er:YAG 2940 nm and Nd:YAG 1064 nm wavelengths units. The laser protocol will follow the instructions of the manufacturer (TwinLight protocol) and consists of degranulation of necrotic soft tissue and bone, implant surface disinfection and creating spot bleeding in bone with Er:YAG and deep disinfection and biomodulation with Nd:YAG.
Intervention Type
Other
Intervention Name(s)
standard
Intervention Description
Granulation tissue elimination, mechanical instrumentation of the implant surface and curettage of intraosseous or supracrestally bone defects will be accomplished using plastic curets, under irrigation with sterile saline solution. Cotton pellets soaked in sterile saline solution will be use to clean debris and remains of removed tissue.
Primary Outcome Measure Information:
Title
Proportion of participants with treatment success
Description
Treatment success defined as implant survival with the absence of peri-implant probing depths (PD) greater than 5 mm with concomitant bleeding/suppuration and absence of progression of peri-implant bone loss.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Plaque index
Description
(PI)
Time Frame
1 month
Title
Plaque index
Description
(PI)
Time Frame
3 months
Title
Plaque index
Description
(PI)
Time Frame
6 months
Title
Plaque index
Description
(PI)
Time Frame
12 months
Title
Bleeding on probing
Description
(BOP) evaluated as present if bleeding was evident within 30 s after probing, or absent, if no bleeding was noticed within 30 s after probing.
Time Frame
1 month
Title
Bleeding on probing
Description
evaluated as present if bleeding was evident within 30 s after probing, or absent, if no bleeding was noticed within 30 s after probing.
Time Frame
3 months
Title
Bleeding on probing
Description
evaluated as present if bleeding was evident within 30 s after probing, or absent, if no bleeding was noticed within 30 s after probing.
Time Frame
6 months
Title
Bleeding on probing
Description
evaluated as present if bleeding was evident within 30 s after probing, or absent, if no bleeding was noticed within 30 s after probing.
Time Frame
12 months
Title
Probing depth
Description
measured from the mucosal margin to the bottom of the pocket.
Time Frame
1 month
Title
Probing depth
Description
measured from the mucosal margin to the bottom of the pocket.
Time Frame
3 months
Title
Probing depth
Description
measured from the mucosal margin to the bottom of the pocket.
Time Frame
6 months
Title
Probing depth
Description
measured from the mucosal margin to the bottom of the pocket.
Time Frame
12 months
Title
Mucosal recession
Description
measured from the mucosal margin to the bottom of the pocket.
Time Frame
1 month
Title
Mucosal recession
Description
measured from the mucosal margin to the bottom of the pocket.
Time Frame
3 months
Title
Mucosal recession
Description
measured from the mucosal margin to the bottom of the pocket.
Time Frame
6 months
Title
Mucosal recession
Description
measured from the mucosal margin to the bottom of the pocket.
Time Frame
12 months
Title
Clinical attachment level gain
Description
Difference in clinical attachment level at baseline and follow up.
Time Frame
1 month
Title
Clinical attachment level gain
Description
Difference in clinical attachment level at baseline and follow up.
Time Frame
3 months
Title
Clinical attachment level gain
Description
Difference in clinical attachment level at baseline and follow up.
Time Frame
6 months
Title
Clinical attachment level gain
Description
Difference in clinical attachment level at baseline and follow up.
Time Frame
12 months
Title
Quality of life questionnaire
Description
Oral Health Impact Profile-14 on the scale from 0 to 56 with higher scores indicating a poorer oral health-related quality of life.
Time Frame
0 months
Title
Quality of life questionnaire
Description
Oral Health Impact Profile-14 on the scale from 0 to 56 with higher scores indicating a poorer oral health-related quality of life.
Time Frame
1 month
Title
Quality of life questionnaire
Description
Oral Health Impact Profile-14 on the scale from 0 to 56 with higher scores indicating a poorer oral health-related quality of life.
Time Frame
3 months
Title
Quality of life questionnaire
Description
Oral Health Impact Profile-14 on the scale from 0 to 56 with higher scores indicating a poorer oral health-related quality of life.
Time Frame
6 months
Title
Quality of life questionnaire
Description
Oral Health Impact Profile-14 on the scale from 0 to 56 with higher scores indicating a poorer oral health-related quality of life.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
at least one implant with peri-implantitis
no serious mobility of the implants
written informed consent of the voluntary participant in the study
availability of participant for control visits for a follow-up of at least 12 months without interruptions
Exclusion Criteria:
serious systematic disease
pregnancy
current use of photosensitive drugs, bisphosphonate medication or antibiotics
patients who do not want to follow post treatment recommendation of oral hygiene and follow-up visits
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luis Monteiro, DMD, PhD
Phone
+351 919120226
Email
luis.monteiro@iucs.cespu.pt
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luis Monteiro, DMD, PhD
Organizational Affiliation
Instituto Universitário de Ciências da Saude, CESPU
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Universitário de Ciências da Saude, CESPU
City
Porto
ZIP/Postal Code
4585-116
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis Monteiro
Phone
+351 919120226
Email
luis.monteiro@iucs.cespu.pt
12. IPD Sharing Statement
Plan to Share IPD
No
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Combined Er:YAG And Nd:YAG Laser Protocol For Treatment Of Peri-Implantitis
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