Regular Home Use of Dual-light Photodynamic Therapy as an Adjunct to Non-surgical Periodontal Treatment in Smokers
Phase: NA
Conditions: Periodontitis, Dual- Light Photodynamic Therapy, Smoking, Cigarette, Non-surgical Periodontal Therapy
Sponsor: Aristotle University Of Thessaloniki

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Regular home use of dual-light photodynamic therapy as an adjunct to 
non-surgical periodontal treatment in smokers 
10.16.22 
 
 

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Clinical investigation plan (CIP) 
Study title: 
Pages 
Regular home use of dual-light photodynamic therapy as an 
adjunct to non-surgical periodontal treatment in smokers 
 
Study code: Thss1 
Version 
Date 
FINAL 
 
 
Revision 
No. 
Change details and rationale 
Author/Effective 
date 
Accepted 
1. 
2. 
First version 
Second version 
Tommi Pätilä 
Dimitra Sakellari 
Aikaterini-
Elisavet Doufexi 
Chrysoula Vakaki 
 
 
Principal investigator: 
Dimitra Sakellari, Professor  
Department of Preventive Dentistry,Periodontology and Implant 
Biology,(AUTh) · Aristotle University of Thessaloniki 
Central Office, A' basement Zip code 54124, Thessaloniki 
Tel. + 
mailto:dimisak@gmail.com 
 
Coordinating investigator:  
Timo Sorsa, Professor 
University of Helsinki 
Department of Oral and Maxillofacial Diseases 
Biomedicum 1 Helsinki, Haartmaninkatu 8 00290 Helsinki, 
Finland, Tel. +358 504151327/ +358 294127294  
email: timo.sorsa@helsinki.fi  
 
 
Investigators:  
This project will serve as the M.Sc  thesis of the 2nd year 
postgraduate student, Chrysoula Vakaki, at the Department of 
Preventive Dentistry, Periodontology and Implant Biology  
Chrysoula Vakaki, Periodontist, vakakichri@gmail.com 
Aikaterini-Elisavet Doufexi, Assistant 
Professor,vdoufexi@yahoo.com 
Ismo Räisänen, PhD, ismo.raisanen@helsinki.fi 
Tommi Pätilä, MD, PhD tommi.patila@gmail.com 
 

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Investigational site:  
Department of Preventive Dentistry, Periodontology and Implant 
Biology, (AUTh) · Aristotle University of Thessaloniki 
Central Office, A' basement Zip code 54124, Thessaloniki 
 
Other institutions: 
University of Helsinki 
Department of Oral and Maxillofacial Diseases 
Biomedicum 1 Helsinki, Haartmaninkatu 8,  
00290 Helsinki, Finland 
Overall synopsis of the clinical investigation 
 
Study title:  Regular home use of dual-light photodynamic therapy as an adjunct to non-surgical 
periodontal treatment in smokers 
Type: Investigator initiated study  
Study Center:  Department of Preventive Dentistry, Periodontology and Implant Biology, (AUTh) · 
Aristotle University of Thessaloniki 
 
Name of the Investigational Medical Device (IMD): 1) Lumoral treatment device 2) Lumorinse 
mouth rinse 
Manufacturer of the Investigational Device: Koite Health Oy, Kutojantie 2 C, 02630 Espoo 
Study code:  Thss1 
Investigators and the study center: Principal Investigator:  Dimitra Sakellari; Coordinating 
Investigator:   Timo Sorsa; Investigators:  Chrysoula Vakaki, Aikaterini- Elisavet Doufexi, Ismo Räisänen, 
Tommi Pätilä 
Study initiation and ending date: 01.09.2022 to 01.09.24 
Objectives:  To investigate the impact of regular home use of Lumoral device as an adjunct treatment  
compared to  non-surgical periodontitis treatment alone on biofilm removal and host response in 
Stage III and Grade C smoking periodontitis patients at 3 months. 
Methodology: Randomized study; randomization method:  www.randomizer.org 
Sample size: 60 subjects, 30 subjects in the study group, and 30 in the control group. The subjects 
have a referral to visit a specialist dentist/ periodontist 
Main criteria for inclusion:   Periodontal disease Stage III and Grade C with at least 6 sites with 
probing depth (PD) and clinical attachment loss (CAL) ≥5 mm and bleeding on probing (BOP) ≥15 
teeth; aged ≥35; smokers smoking≥10 cigarettes per day, at least 18 years old, presence of ≥20 
teeth, agreement to participate in the study and a written consent form signed. 
Main criteria for exclusion: Presence of any physical limitation or restriction that might restrict 
Lumoral use,  need for prophylactic antimicrobial coverage; scaling and root planing performed during 
the previous 6 months; non-smoking status or smoking less than 10 cigarettes per day; antimicrobial 
therapy in the previous 6 months; immune modifying conditions/ diseases (e.g., diabetes mellitus, 
rheumatoid arthritis, and osteoporosis); long-term use of medication that could interfere with 
periodontal response (e.g., bisphosphonates); pregnancy or lactation. 

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Study flowchart/ Schedule of visits and study procedures 
 
 
 
 
 
 
 
 
 
Comparative: None 
Estimated duration of the data gathering in the clinical investigation: 6 months 
Assessments:  
Primary outcome:  Difference in the number of reduced deep pockets (i.e. PD≤ 4mm, no BOP) 
between the test and the control group.    
Secondary outcome:    PD, CAL, BOP, Turetsky Modified Quigley-Hein Plaque Index (TMQHPI), levels 
of MMP-8, and Oral Health Quality of Life (OHQL). Need for optional SRP 
Statistical methods: Wilcoxon test, Mann-Whitney U-test, Fisher’s test, Pearson’s correlation test 
aMMP-8, TMQHPI, BOP, PPD, CAL, OHQL 
Re-evaluation session 
aMMP-8, TMQHPI, BOP, PPD, CAL, OHQL 
Re-evaluation session 
Patients referred to a periodontist 
Preliminary assessment, full mouth X-rays  
If included in the study, informed consent, 
and randomization. 
aMMP-8, TMQHPI, BOP  
SRP in two sessions in 2 weeks 
2 weeks 
10 weeks 
Maintenance control:  
aMMP-8, PPD, TMQHPI, BOP, CAL 
 OHQL 
Potential Microbial sampling (the same 
periodontal pocket) 
Maintenance control:  
aMMP-8, PPD, TMQHPI, BOP, CAL 
 OHQL 
Potential Microbial sampling (the same 
periodontal pocket) 
Lumoral group 
Control group 
aMMP-8, PPD, TMQHPI, BOP, CAL 
 Potential Microbial sampling (deepest 
periodontal pocket). Hygiene instructions. 
Start   
of Lumoral or control treatment 
1 week 
1st visit 
2st visit 
5th visit 
aMMP-8, TMQHPI, BOP 
SRP in two sessions in 2 weeks 
Time 0 
6th visit 
12 weeks 
Total time:  24 weeks from time 0 
3rd and 4th 
visit 

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Power Calculation  
Previous results showed statistically significant changes in plaque development in 15 patients in a 
randomized, split-mouth study (Nikinmaa et al. 2021a). In this clinical study plan, more effective 
antibacterial therapy shall be used. According to our published laboratory analysis, the dual-light 
antibacterial treatment would be at least a 3-log scale more potent than the treatment used in the split-
mouth protocol (Nikinmaa 2021). In another pilot study in peri-implant patients using this more effective 
treatment, a significant change in plaque was already observed in the data of seven patients during four 
weeks of Lumoral treatment (Lähteenmäki et al., 2022). 
Based on this limited but promising available data, a power calculation (SAS 9.4, Cary, NC, USA) was 
performed and levels for 5% alpha error and 20% TYPE II error (80% power) were determined. It was 
Visit #/code 
 
 
1 
2 
3 
4 
5 
X 
Reason for visit 
Screening/ 
Baseline/ 
 
Start of the 
intervention 
 
2-week follow-
up/ SRP in 2 
sessions in 2 
weeks 
        10 
-week 
follow-up 
3 month follow-
up 
Termination 
Inclusion/ exclusion 
criteria 
x 
 
 
 
 
 
Informed consent 
x 
 
 
 
 
 
Subject ID 
x 
 
  
 
 
 
 
 
 
 
 
 
 
Subject demography 
x 
 
 
 
 
 
Medications 
(changes*) 
x 
 
 
 
x* 
 
Oral and general 
disease history 
(changes*) 
x 
 
 
 
x* 
 
Assessments 
 
aMMP-8 sampling 
(oral rinse) 
 
x 
x 
x 
x 
 
Potential Microbial 
sampling 
(periodontal 
pocket) 
 
x 
 
x 
x 
 
Full mouth X-rays 
x 
 
 
 
 
 
BOP% 
 
x 
 
x 
x 
 
TMQHPI % 
 
x 
x 
x 
x 
 
PPD 
 
x 
 
x 
x 
 
CAL 
 
x 
 
x 
x 
 
Oral hygiene 
instructions 
 
x 
x 
x 
x 
 
Lumoral instructions 
(only study group) 
 
x 
x 
x 
x 
 
Lumoral diary for use 
(only study group) 
 
x 
x 
x 
x 
 
Reason for 
termination 
 
 
 
 
 
x 
AE/ADE/SAE/ 
SADE/DD 
 
 
x 
x 
x 
x 

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concluded that the sample size of 25 patients in each study arm was sufficient to allow statistical 
calculations. 30 + 30 patients were assigned to cover possible dropouts.  
 
Recruitment, 
randomization 
full mouth x-
rays, informed 
consent
1wk
aMMP-8, PPD, 
TMQHPI, BOP, 
CAL, Potential 
Microbial 
Sampling
Start of 
Lumoral or 
control 
treatment
2wks
aMMO-8, 
TMQHPI, BOP
SRP in two 
sessions in two 
weeks + 
Lumoral or 
control
10wks
aMMP-8, 
TMQHPI, BOP, 
PPD, CAL, 
OHQL
Re-evaluation 
session
FULL MOUTH 
ULTRASONIC 
SUPRAGINGIVA
LLY 
ADDITIONAL 
SRP IF 
REQUIRED
12wks
Maintance 
control.
aMMP-8, PPD, 
TMQHPI, BOP, 
CAL, OHQL
Potential 
MIcrobial 
Sampling
(the same 
periodontal 
pocket)
-1 
Time 0 
Total time: 24 weeks from time 0