Treatment of Peri-implant Mucositis Using an Er:Yag Laser or an Ultrasonic Device. A Randomized Clinical Trial
Phase: NA
Conditions: Peri-implant Mucositis
Sponsor: Kristianstad University

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2020-09-02   NCT 05772299
RESEARCH PROPOSAL 
Treatment of peri-implant mucositis 
using an Er: YAG laser or an ultrasonic 
device. A randomized clinical trial.

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Background and Significance  
Peri-implantitis is an inflammatory process resulting in loss of supporting bone whereas 
peri-implant mucositis has been defined as a reversible inflammatory change of the 
peri-implant soft tissues without bone loss (Renvert et al 2018, Berglund et al. 2018). 
The prevalence of peri-implant mucositis and peri-implantitis ranged from 19 to 65% 
and from 1 to 47%, respectively. Meta-analyses estimated weighted mean 
prevalence’s of peri-implant mucositis and peri-implantitis of 43% (CI: 32–54%) and 
22% (CI: 14–30%), respectively (Derks et al. 2015). With an increasing population with 
dental implants the prevalence of implant related infections will increase and cause 
major challenges to the profession and society.  
 
Approximately 65% of all infectious diseases are associated with biofilms including 
periodontal and peri-implant infections (Costerton et al. 1999, Lamont and Jenkinson 
2000, Socransky & Haffajee 2005, Lee et al. 1999, Leonhardt et al. 2003, Roos-
Jansåker et al. 2003). Bacterial colonization on oral implant surfaces occurs rapidly 
(Quirynen et al. 2006, Fürst et al. 2007, Salvi et al. 2007). The development of a tightly 
fixed layer of plaque, the so-called bio-film is critical and would in principle cause an 
irreversible binding to the implant surface (Lamont and Jenkinson 2000). The goal with 
non-surgical therapy of peri-implantit mucositis is to eliminate or significantly reduce 
the levels of pathogens to a level allowing healing and a clinically healthy situation. 
 
Eradication of pathogens by mechanical means on the implant surface with threads 
and often a rough surface structure may be difficult using conventional means of 
therapy. Dental implants have generally a screw shaped design and in order to 
facilitate healing and osseo integration the surface structure is often rough. In case of 
infection and microbial colonization of the implant surface these features, positive for 
the initial stabilization and healing of the implant, becomes treatment complicating 
factors. Treatment models effectively used to treat the root surfaces of the tooth with 
periodontal disease like scaling and root-planning are difficult to use on the rough 
threaded implant surface. This surface gives the micro organisms “protected areas” 
with the roughness of the surface. In a consensus paper on the treatment of peri-
implant mucositis it was concluded that” It has not been documented that mechanical 

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therapy alone is effective in reducing bleeding o probing” (Lindhe & Meyle 2008). 
Accordingly, methods have been aiming at eradication of the micro-organisms from a 
distance. In this aspect, the adjunct of local antibiotics has been attempted. (i.e. 
Flemmig 1994, Kao et al. 1997, Lang et al. 1997, Porras et al. 2002, Renvert et al. 
2004,2006, Persson et al. 2006, Jorgensen et al. 2004, Bonito et al. 2005, McColl et 
al. 2006). The adjunct effects using local antibiotics are, however, not conclusive.  
 
Another new treatment model, the use of lasers has been proposed for the treatment 
of peri-implant mucositis and peri-implantitis. The use of a laser can be considered a 
minimally invasive technique, that may result in less discomfort than traditional 
mechanical treatment approaches. Furthermore, lasers may have bio stimulatory 
effects that are reported to result in better wound healing compared to traditional 
approaches and in periodontal tissue regeneration (Aoki et al. 2004). In an 
experimental peri-implantitis model in dogs, it was demonstrated that favorable 
formation of new bone was observed on the laser-treated implant surface, and the 
laser group showed a tendency to produce greater bone-to-implant contact than the 
curette group (Takasaki et al. 2007). In a randomized clinical trial comparing the use 
of an Er:YAG laser and an air abrasive device in the treatment of peri-implantitis it was 
found that bleeding on probing (BOP) and suppuration (SUP) decreased in both the 
groups (p<0.001). The mean probing depth (PPD) reductions in the air abrasive and 
laser treated groups were 0.9mm (SD ± 0.8) and 0.8mm (SD ± 0.5) (Renvert et al. 
2011). 
In a recent review of the evidence using lasers in the treatment of peri-implant diseases 
it was concluded that the current evidence shows laser therapy in combination with 
surgical/nonsurgical therapy provided minimal benefit in Pocket depth (PD) reduction 
and clinical attachment (CAL) but when adjunct to non-surgical therapy might result in 
more BOP reduction in the short term (Lin et al. 2018). It was also concluded that data 
on adjunctive laser treatment for peri-implant mucositis are 
scarce. Therefore, future clinical trials are needed to evaluate the potential benefit of 
this approach.  
 
In summary, peri-implant mucositis is a very common clinical entity in patients with 
dental implants. This inflammation in the peri-implant mucosa may develop into peri-
implantitis and result in implant loss. Early and effective treatment of peri-implant 

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mucositis is therefore an important continuous task for the dental professions. It is 
imperative to perform randomized trials comparing treatment alternatives to control 
implant infections. The present research project is designed to compare a conventional 
non-surgical approach using an ultrasonic device with an Er: YAG laser device (Morita 
Corporation, Japan). Clinical outcome measures of therapy will be used under observer 
masked conditions. 
 
Specific aims 
To assess the clinical outcome over 6 months following treatment with non-surgical 
debridement using a Er: YAG laser device (AdvErL EVO, Morita corporation, Japan) 
or with the use mechanical therapy using ultrasonic device with a specially designed 
tip (EMS, Switzerland) 
Materials and methods 
Outcome variables 
• The extent of gingival inflammation (bleeding on probing - BOP) 
• Clinical probing pocket depth values 
• Clinical registration of suppuration 
• Recession of the peri-implant mucosal margin at test and control sites 
between baseline and at study endpoint (6 months) 
• The treatment times 
•  Changes in “bone levels” (measured from periapical radiographs (see 
below)  
• The prevalence of implant loss 
Subject screening  
Exclusion criteria 
• Subjects with uncontrolled diabetes mellitus (HbA1c > 6.5) 
• Subjects requiring prophylactic antibiotics 
• Subjects taking prednisolone 
• Subjects taking medications known to have effects on gingival growth 

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• Subjects with a history of taking systemic antibiotics in the preceding 1 month 
 
Inclusion criteria - Presence of peri-implant mucositis 
Following a review of the medical history (see exclusion criteria) a full mouth routine 
periodontal examination, including analysis of available radiographs, will be performed. 
Subjects who consent and: 
1. Have a minimum of one or more peri-implant sites with probing depth ≥ 4 mm 
combined with bleeding and/or pus on probing using 0.2 N probing force. 
2.  No peri-implant marginal bone loss (as determined from a comparison of the 
bone level one year following implant reconstruction with the bone level at 
screening (screening radiograph) 
3. A limited allowed bone loss ≤ 2mm measured from the implant shoulder (as a 
consequence of remodeling during the healing process) 
Intraoral radiographs 
Intraoral standardized radiographs of the site of interest will be taken at baseline and 
at 6 months. Radiographs will be analysed by an independent and blinded examiner.  
 
Treatment procedure 
 
Baseline measurements will be performed, and the patients are randomized into 
treatment groups A or B. The treatment will be performed by a dentist not involved in 
the registrations in order to avoid bias. Following treatment, the patients will be 
instructed in proper homecare using a toothbrush and interproximal aids as needed.  
Group A will be treated using the ER: YAG laser device (AdvErL EVO, Morita 
Corporation, Japan). The tip is placed in the pocket mesially, lingually, distally and 
buccally. Careful attempts are to cover the full circumference of the implant. Moving 
motion would be from bottom to coronal, sweeping motion also covering the soft 
tissue surface.  

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Group B will be treated using an ultrasonic device with PEEK coated tips (EMS, 
Switzerland). The tip is placed in the pocket mesially, lingually, distally and buccally. 
Careful attempts are to cover the full circumference of the implant.  
Material and settings 
The device used for the clinical study for Group A will be an Er:YAG laser device 
(AdvErL EVO, J. MORITA MFG. CORP., Japan) using a below prameter. Group B will 
receive standard of care using an ultrasonic device with plastic coated tips. 
Parameter of Er:YAG laser AdvErL EVO (on the display) 
Tip:PS400T 
Power:30-50mJ 
Frequency:10PPS 
Air/Water:7/7 
 
Patient entry 
The study will be submitted to the Ethics committee in Uppsala and written consent will 
be obtained from all subjects to be entered in the study. Once the entry criteria have 
been confirmed the subject will be entered to the study and assigned a patient number. 
After having been entered into the study, subjects will be randomly assigned to one of 
the two treatment regimens. Random assignment will be performed according to pre-
defined randomisation.  
Subject protection – monitoring of adverse events 
At each visit the clinician will evaluate patients for any adverse events. Should a patient 
require any treatment during the course of the study, the necessary treatment will be 
provided at the discretion of the clinician and according to the current standard of care. 
All adverse events related to the treatment provided will be recorded. The investigation 
will be performed according to the principles of the Declaration of Helsinki on 
experimentation involving human subjects.  

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Measurements  
One and the same examiner, unaware of treatment group for the patient, will perform 
all the measurements. Before treatment the following baseline measurements will be 
recorded: 
1. Intraoral photographs of the implant site 
2. Presence/absence of hyperplasia 
3. Full mouth plaque score (FMPS). Presence of dental plaque along the 
gingival/mucosal margin recorded after use of disclosing dye and expressed as a 
percentage of examined sites within each patient (4 sites per tooth and implant).  
4. Local Plaque Score. Presence of dental plaque along the mucosal margin at 6 sites 
of each treated implant recorded after use of disclosing dye and expressed as a 
percentage of implant sites within each patient. 
5. Probing pocket depths (PPD) at the implant (6 sites/implant). Recorded at 6 sites 
of each treated implant to the nearest mm using a plastic probe. 
6. Recession of the mucosal margin relative to the restoration margin (REC) at the 
implant buccally. Position of the mucosal margin apical to the restoration margin is 
positive recession (+), position of the mucosal margin coronal to the restoration 
margin is negative recession (-). 
7. Bleeding on probing (BOP) graded 0-3 at the implant (6 sites/implant). Bleeding 
appearing after measurement of probing depth and expressed as: 0=no bleeding, 
1=a dot of bleeding, 2=a line of bleeding, 3=a drop of bleeding  
8. Presence /absence suppuration (SUP) at the implant (6 sites/implant). 
9. Presence/absence of bleeding on probing (BOP) at all teeth/implants (4 sites) 
10. Treatment times  
11. Patient evaluation of the treatment: Visual analog scale for pain during treatment, 
the same day after treatment, one day after treatment and three days after 
treatment. Visual analog scale for aesthetic/satisfaction before the baseline 
examination and before the examination at 6 months. Postoperativ complications 

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is asked for in the examination protocol as an open question. Oral health impact 
profile is measured with the OHIP-14 version. 
 
• All probing measurements will be made using a manual plastic probe.  
• Clinical indices concerning probing pocket depths (PPD), bleeding on probing 
(BOP), plaque and suppuration will be recorded as 6 sites per implant: mesio-
buccal, mid-buccal, disto-buccal, disto-lingual, mid-lingual, mesio-lingual.  
• Full mouth plaque scores (FMPS) will be recorded as the percentage of total 
surfaces (4 aspects per tooth/implant) that revealed the presence of plaque 
(O'Leary et al. 1972). Full mouth bleeding scores (FMBS) will be recorded as 
the percentage of total surfaces (4 aspects per tooth/implant) that revealed the 
presence of bleeding. 
Statistical power analysis 
If BOP is reduced to 30 % ± 10 in Group A and with 30 % decrease in group B is to be 
detected at α = 0.05 and a power of β = 0.2, the appropriate number of subjects would 
be around n = 38. Hence, it is foreseen to incorporate 45 subjects in the study if some 
of the individuals will not fulfil the study.  
Allocation concealment 
Assignment to test and control group will be made using pre-prepared randomization 
in groups A or B. Cards with group identification will be prepared and placed in 
numbered envelopes after randomization. This will be done by a person not involved 
in the treatment or diagnosis of patients. As a new patient is admitted to the study the 
treating clinician takes the next numbered envelope then assigning the patient to either 
group A or B. The code for treatment A and B will be broken once the study is 
completed and the data set is locked. 
Clinical registrations and treatment at baseline  
• Clinical photo 
• Presence/absence of plaque (6 sites/implant) 
• PPD (6 sites/implant) 

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• Recession of the buccal mucosal margin 
• BOP (6 sites/implant) graded 
• Presence/absence of suppuration (6 sites/implant) 
• FMPS (4 sites per tooth/implant) 
• FMBS (4 sites per tooth/implant) 
• Prescence/absence of hyperplasia 
• Radiograph of the treated site 
• Oral hygiene instruction + subgingival treatment in accordance to 
randomization 
• Patient evaluation of the treatment including a VAS scale for pain. And 
another for aesthetic/satisfaction. OHIP-14 for quality of life assessment 
in relation to oral health. 
 
Clinical registrations - 1 month 
• Clinical photo 
• Presence/absence of plaque (6 sites/implant) 
• PPD (6 sites/implant) 
• BOP (6 sites/implant) graded 
• Presence/absence of suppuration (6 sites/implant  
• FMPS (4 sites per tooth/implant)  
• Re-instructions in oral hygiene procedures  
 
Clinical registrations and supportive treatment at 3 months 
• Clinical photo 
• Presence/absence of plaque (6 sites/implant) 
• PPD (6 sites/implant) 
• Recession of the buccal mucosal margin 
• BOP (6 sites/implant) graded 
• Presence/absence of suppuration (6 sites/implant) 

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• Presence/absence of hyperplasia 
• FMPS (4 sites per tooth/implant) 
• FMBS (4 sites per tooth/implant) 
• Oral hygiene instruction + subgingival treatment in accordance to 
randomization 
• Patient evaluation of the treatment including a VAS scale for pain.  
 
Clinical registrations and therapy at 6 months 
• Clinical photo 
• Presence/absence of plaque (6 sites/implant) 
• PPD (6 sites/implant) 
• Recession of the buccal mucosal margin 
• BOP (6 sites/implant) graded 
• Presence/absence of suppuration (6 sites/implant) 
• Presence/absence of hyperplasia 
• FMPS (4 sites per tooth/implant) 
• FMBS (4 sites per tooth/implant) 
• Radiograph of the treated site. 
• Oral hygiene instruction + Subgingival treatment in accordance to 
randomization 
• Patient evaluation of the treatment including a VAS scale for pain and 
another for aesthetic/satisfaction. OHIP-14 for quality of life assessment 
in relation to oral health.  
 
 
Table1. Summary of study design. 
Group 
Baseline 
1 month  
3 months 
6 months 
A 
Clinical data 
Radiographs 
Treatment 1 
Clinical data 
Oral hygiene instructions 
Clinical data 
Oral hygiene 
instructions 
Clinical data 
Radiographs 

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Treatment 1 
Oral hygiene 
instructions 
Treatment 1 
 
 
2 
 
 
Clinical data 
Radiographs 
Treatment 2 
Clinical data 
Oral hygiene instructions 
Clinical data  
Oral hygiene 
instructions 
Treatment 2 
 
 
Clinical data 
Radiographs 
Oral hygiene 
instructions 
Treatment 2 
 
 
Timetable: This project will be initiated during 2021 and completed during 2023. 
 
 
 

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