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Use of Dual-light Photodynamic Therapy as an Adjunct to Periodontal Treatment in Smokers

Primary Purpose

Periodontitis, Dual- Light Photodynamic Therapy, Smoking, Cigarette

Status
Recruiting
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Lumoral device, Lumorinse
Sponsored by
Aristotle University Of Thessaloniki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis focused on measuring periodontitis, periodontal diseases, photodynamic therapy, photothermal therapy, smoking, non-surgical periodontitis therapy

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 Exclusion Criteria: Patients allergic to indocyanine Patients with active carious lesions Need for prophylactic antimicrobial coverage Scaling and root planing in the previous 6 months Non-smoking status or smoking less than 10 cigarettes per day Antimicrobial therapy in the previous 6 months Immunomodifying conditions/ diseases (e.g. diabetes mellitus, rheumatoid arthritis, osteoporosis) Long-term use of medication that could interfere with periodontal response (e.g. biphosphonates) Pregnancy or lactation

Sites / Locations

  • Dental School of Aristotle University of ThessalonikiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Lumoral users

Lumoral non-users

Arm Description

Use of Lumoral device and Lumorinse mouthwash once per day for 6 months and performance of oral hygiene twice per day for 6 months.

No use of Lumoral device and Lumorinse mouthwash. Performance of oral hygiene twice per day for 6 months.

Outcomes

Primary Outcome Measures

Changes in bleeding on probing (BOP)
Changes in the presence of bleeding when probing at 6 sites per tooth. It is evaluated dichotomously.

Secondary Outcome Measures

Changes of pocket depths
Changes in measurement in millimeters of the depth from the gingival margin to the epithelial attachment in unhealthy gingival tissue at 6 sites per tooth
Changes in clinical attachment level
Changes in measurement of the position of the gingival margin in relation to the cemento-enamel junction (CEJ) at 6 sites per tooth
Difference in the number of "closed" pockets
Differences in the number of pockets with depth≤ 4mm and no BOP between the test and the control group
a-MMP8 saliva concentration
Periosafe chair-side tests and the ORALyzer (an advanced lateral flow (aLF) reader) are utilized in order to quantify active MMP-8 in subjects' saliva
Changes in Turetsky Modified Quigley-Hein Plaque Index (TMQHPI)
Changes in TMQHPI in buccal surfaces of the upper and lower anterior teeth. A score of 0 to five is assigned to each buccak surface of upper and lower anterior teeth, as follows: 0 = No plaque. = Separate flecks of plaque at the cervical margin of the tooth. = A thin continuous band of plaque (up to one mm) at the cervical margin of the tooth. = A band of plaque wider than one mm but covering less than one-third of the crown of the tooth. = Plaque covering at least one-third but less than two thirds of the crown of the tooth. = Plaque covering two-thirds or more of the crown of the tooth. An index for the anterior teeth is determined by dividing the total score by the number surfaces examined. The score is rounded up to the second decimal number and it ranges from 0 to 5.
Oral health-related quality of life questionnaire (OHQL)
OHQL includes the following questions: Did you use Lumoral® as instructed to you? Did you find Lumoral® easy to use? Did you feel any discomfort when using Lumoral®? Did you discontinue the use of Lumoral® due to this discomfort? Did Lumoral® help you perform oral hygiene? Has bad breath been decreased? Has bleeding of the gums been decreased? Would you recommend Lumoral®? Would you buy Lumoral® if its cost was about 200 €? All questions will be answered with a 'Yes' or 'No'
Changes in the presence of periopathogens in the deepest pocket
Subgingival plaque sample is collected from the deepest pocket of each patient and the presence of periopathogens is detected

Full Information

First Posted
July 19, 2023
Last Updated
September 30, 2023
Sponsor
Aristotle University Of Thessaloniki
Collaborators
University of Helsinki
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1. Study Identification

Unique Protocol Identification Number
NCT05962801
Brief Title
Use of Dual-light Photodynamic Therapy as an Adjunct to Periodontal Treatment in Smokers
Official Title
Regular Home Use of Dual-light Photodynamic Therapy as an Adjunct to Non-surgical Periodontal Treatment in Smokers
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 23, 2023 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aristotle University Of Thessaloniki
Collaborators
University of Helsinki

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
The goal of this controlled clinical trial is to investigate the impact of regular home use of Lumoral device as an adjunct treatment compared to non-surgical periodontitis treatment (NSPT) alone on biofilm removal and host response in Stage III and Grade C smoking periodontitis patients at 6 months.The main question aims to answer is: • Does regular use of dual-light photodynamic therapy benefit NSPT in Stage III and Grade C smoking periodontitis patients? 30 participants will be asked to use Lumoral device every night before performing oral hygiene for 10 minutes, while the other 30 patients will be asked to perform only oral hygiene. Both of these groups will receive NSPT and will be followed for 6 months from baseline.
Detailed Description
The objective of this study is to investigate the impact of regular home use of Lumoral device® as an adjunct treatment compared to non-surgical periodontal treatment alone on biofilm removal and host response in Stage III and Grade C smoking periodontitis patients at 6 months. Lumoral® is based on a dual-wavelength LED light that activates Lumorinse® (exocellular) and bacteria porphyrins (endocellular), resulting in the formation of reactive oxygen species (ROS). ROS and heat induce a series of photochemical and biological events that cause irreversible inactivation leading to the death of undesired bacteria. This device is designed for home use. Therefore it is hypothesized that its adjunct use in the treatment of periodontitis could lead to better outcomes compared to traditional periodontal treatment. In order to investigate this impact, clinical and microbiological measurements will be compared between patients who will be treated with conventional non-surgical periodontal treatment and patients who will receive the Lumoral device® as an adjunct to the periodontal treatment. The patients who receive the device will use it every day for four months. Both groups will be followed for 6 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Dual- Light Photodynamic Therapy, Smoking, Cigarette, Non-surgical Periodontal Therapy
Keywords
periodontitis, periodontal diseases, photodynamic therapy, photothermal therapy, smoking, non-surgical periodontitis therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, controlled clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lumoral users
Arm Type
Active Comparator
Arm Description
Use of Lumoral device and Lumorinse mouthwash once per day for 6 months and performance of oral hygiene twice per day for 6 months.
Arm Title
Lumoral non-users
Arm Type
No Intervention
Arm Description
No use of Lumoral device and Lumorinse mouthwash. Performance of oral hygiene twice per day for 6 months.
Intervention Type
Device
Intervention Name(s)
Lumoral device, Lumorinse
Intervention Description
Regular use of dual-light photodynamic therapy at home
Primary Outcome Measure Information:
Title
Changes in bleeding on probing (BOP)
Description
Changes in the presence of bleeding when probing at 6 sites per tooth. It is evaluated dichotomously.
Time Frame
baseline, 2 weeks, 2 months, 6 months
Secondary Outcome Measure Information:
Title
Changes of pocket depths
Description
Changes in measurement in millimeters of the depth from the gingival margin to the epithelial attachment in unhealthy gingival tissue at 6 sites per tooth
Time Frame
baseline, 2 months, 6 months
Title
Changes in clinical attachment level
Description
Changes in measurement of the position of the gingival margin in relation to the cemento-enamel junction (CEJ) at 6 sites per tooth
Time Frame
baseline, 2 months, 6 months
Title
Difference in the number of "closed" pockets
Description
Differences in the number of pockets with depth≤ 4mm and no BOP between the test and the control group
Time Frame
baseline, 2 months, 6 months
Title
a-MMP8 saliva concentration
Description
Periosafe chair-side tests and the ORALyzer (an advanced lateral flow (aLF) reader) are utilized in order to quantify active MMP-8 in subjects' saliva
Time Frame
baseline, 2 weeks, 2 months, 6 months
Title
Changes in Turetsky Modified Quigley-Hein Plaque Index (TMQHPI)
Description
Changes in TMQHPI in buccal surfaces of the upper and lower anterior teeth. A score of 0 to five is assigned to each buccak surface of upper and lower anterior teeth, as follows: 0 = No plaque. = Separate flecks of plaque at the cervical margin of the tooth. = A thin continuous band of plaque (up to one mm) at the cervical margin of the tooth. = A band of plaque wider than one mm but covering less than one-third of the crown of the tooth. = Plaque covering at least one-third but less than two thirds of the crown of the tooth. = Plaque covering two-thirds or more of the crown of the tooth. An index for the anterior teeth is determined by dividing the total score by the number surfaces examined. The score is rounded up to the second decimal number and it ranges from 0 to 5.
Time Frame
baseline, 2 weeks, 2 months, 6 months
Title
Oral health-related quality of life questionnaire (OHQL)
Description
OHQL includes the following questions: Did you use Lumoral® as instructed to you? Did you find Lumoral® easy to use? Did you feel any discomfort when using Lumoral®? Did you discontinue the use of Lumoral® due to this discomfort? Did Lumoral® help you perform oral hygiene? Has bad breath been decreased? Has bleeding of the gums been decreased? Would you recommend Lumoral®? Would you buy Lumoral® if its cost was about 200 €? All questions will be answered with a 'Yes' or 'No'
Time Frame
2 months, 6 months
Title
Changes in the presence of periopathogens in the deepest pocket
Description
Subgingival plaque sample is collected from the deepest pocket of each patient and the presence of periopathogens is detected
Time Frame
baseline, 2 months, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Patients allergic to indocyanine Patients with active carious lesions Need for prophylactic antimicrobial coverage Scaling and root planing in the previous 6 months Non-smoking status or smoking less than 10 cigarettes per day Antimicrobial therapy in the previous 6 months Immunomodifying conditions/ diseases (e.g. diabetes mellitus, rheumatoid arthritis, osteoporosis) Long-term use of medication that could interfere with periodontal response (e.g. biphosphonates) Pregnancy or lactation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chrysoula Vakaki, Postgraduate
Phone
0030 6979766034
Email
vakakichri@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dimitra Sakellari, Professor
Phone
0030 6945777768
Email
dimisak@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dimitra Sakellari, Professor
Organizational Affiliation
Aristotle University Of Thessaloniki
Official's Role
Study Director
Facility Information:
Facility Name
Dental School of Aristotle University of Thessaloniki
City
Thessaloníki
ZIP/Postal Code
54124
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chrysoula Vakaki, Postgraduate
Phone
0030 6979766034
Email
vakakichri@gmail.com
First Name & Middle Initial & Last Name & Degree
Dimitra Sakellari, Professor
Phone
0030 6945777768
Email
dimisak@dent.auth.gr

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Patients' data will be recorded in the electronic patients' database of the Dental School of Aristotle University of Thessaloniki and only the researchers of this study will have access to them.
Citations:
PubMed Identifier
34033939
Citation
AlSarhan MA, Altammami MA, Alaqeely RS, AlEbdi A, Jasser RA, Otaibi DA, Oraini SA, Habib SR, Alqahtani L, Alduhaymi IS, Alrabiah DK, Alaradi M, Alyamani EJ. Short-term improvement of clinical parameters and microbial diversity in periodontitis patients following Indocyanine green-based antimicrobial photodynamic therapy: A randomized single-blind split-mouth cohort. Photodiagnosis Photodyn Ther. 2021 Sep;35:102349. doi: 10.1016/j.pdpdt.2021.102349. Epub 2021 May 24.
Results Reference
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PubMed Identifier
35723308
Citation
Lahteenmaki H, Patila T, Raisanen IT, Kankuri E, Tervahartiala T, Sorsa T. Repeated Home-Applied Dual-Light Antibacterial Photodynamic Therapy Can Reduce Plaque Burden, Inflammation, and aMMP-8 in Peri-Implant Disease-A Pilot Study. Curr Issues Mol Biol. 2022 Mar 8;44(3):1273-1283. doi: 10.3390/cimb44030085.
Results Reference
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PubMed Identifier
36135158
Citation
Trujiilo K, Raisanen IT, Sorsa T, Patila T. Repeated Daily Use of Dual-Light Antibacterial Photodynamic Therapy in Periodontal Disease-A Case Report. Dent J (Basel). 2022 Sep 1;10(9):163. doi: 10.3390/dj10090163.
Results Reference
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PubMed Identifier
30154936
Citation
Alassiri S, Parnanen P, Rathnayake N, Johannsen G, Heikkinen AM, Lazzara R, van der Schoor P, van der Schoor JG, Tervahartiala T, Gieselmann D, Sorsa T. The Ability of Quantitative, Specific, and Sensitive Point-of-Care/Chair-Side Oral Fluid Immunotests for aMMP-8 to Detect Periodontal and Peri-Implant Diseases. Dis Markers. 2018 Aug 5;2018:1306396. doi: 10.1155/2018/1306396. eCollection 2018.
Results Reference
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PubMed Identifier
23895254
Citation
Jansson H, Wahlin A, Johansson V, Akerman S, Lundegren N, Isberg PE, Norderyd O. Impact of periodontal disease experience on oral health-related quality of life. J Periodontol. 2014 Mar;85(3):438-45. doi: 10.1902/jop.2013.130188. Epub 2013 Jul 29.
Results Reference
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PubMed Identifier
5264376
Citation
Turesky S, Gilmore ND, Glickman I. Reduced plaque formation by the chloromethyl analogue of victamine C. J Periodontol. 1970 Jan;41(1):41-3. doi: 10.1902/jop.1970.41.41.41. No abstract available.
Results Reference
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PubMed Identifier
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Citation
Chambrone L, Wang HL, Romanos GE. Antimicrobial photodynamic therapy for the treatment of periodontitis and peri-implantitis: An American Academy of Periodontology best evidence review. J Periodontol. 2018 Jul;89(7):783-803. doi: 10.1902/jop.2017.170172.
Results Reference
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PubMed Identifier
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Citation
Pakarinen S, Saarela RKT, Valimaa H, Heikkinen AM, Kankuri E, Noponen M, Alapulli H, Tervahartiala T, Raisanen IT, Sorsa T, Patila T. Home-Applied Dual-Light Photodynamic Therapy in the Treatment of Stable Chronic Periodontitis (HOPE-CP)-Three-Month Interim Results. Dent J (Basel). 2022 Nov 2;10(11):206. doi: 10.3390/dj10110206.
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Use of Dual-light Photodynamic Therapy as an Adjunct to Periodontal Treatment in Smokers

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