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

NCT05962801 | Unknown

• 1 other identifier: 176/30-11-2022
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis; Dual- Light Photodynamic Therapy; Smoking, Cigarette; Non-surgical Periodontal Therapy

Keywords

periodontitis; periodontal diseases; photodynamic therapy; photothermal therapy; smoking; non-surgical periodontitis therapy

Outcome Measures

Primary Outcomes (1)

• Changes in bleeding on probing (BOP)

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

  baseline, 2 weeks, 2 months, 6 months

Secondary Outcomes (7)

• Changes of pocket depths

  baseline, 2 months, 6 months

• Changes in clinical attachment level

  baseline, 2 months, 6 months

• Difference in the number of "closed" pockets

  baseline, 2 months, 6 months

• a-MMP8 saliva concentration

  baseline, 2 weeks, 2 months, 6 months

• Changes in Turetsky Modified Quigley-Hein Plaque Index (TMQHPI)

  baseline, 2 weeks, 2 months, 6 months

Study Arms (2)

Lumoral users

ACTIVE COMPARATOR

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

Device: Lumoral device, Lumorinse

Lumoral non-users

NO INTERVENTION

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

Interventions

Lumoral device, Lumorinse DEVICE

Regular use of dual-light photodynamic therapy at home

Lumoral users

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead
• University of Helsinki: collaborator

Study Sites (1)

Dental School of Aristotle University of Thessaloniki

Thessaloniki, 54124, Greece

RECRUITING

Related Publications (9)

• 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.

  PMID: 34033939 BACKGROUND

• 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.

  PMID: 35723308 BACKGROUND

• 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.

  PMID: 36135158 BACKGROUND

• 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.

  PMID: 30154936 BACKGROUND

• 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.

  PMID: 23895254 BACKGROUND

• 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.

  PMID: 5264376 BACKGROUND

• 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.

  PMID: 30133749 BACKGROUND

• 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.

  PMID: 36354651 BACKGROUND

• Vakaki C, Fragkioudakis I, Patila T, Sakellari D. Regular home use of dual-light photodynamic therapy as an adjunct to non-surgical periodontal treatment in smokers: a single-center randomized controlled clinical trial. Clin Oral Investig. 2025 Nov 6;29(12):553. doi: 10.1007/s00784-025-06600-1.

  PMID: 41196397 DERIVED

MeSH Terms

Conditions

Periodontitis; Cigarette Smoking; Periodontal Diseases; Smoking

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Tobacco Smoking; Behavior; Tobacco Use

Study Officials

• Dimitra Sakellari, Professor

  Aristotle University Of Thessaloniki

  STUDY DIRECTOR

Central Study Contacts

Chrysoula Vakaki, Postgraduate

CONTACT

0030 6979766034; vakakichri@gmail.com

Dimitra Sakellari, Professor

CONTACT

0030 6945777768; dimisak@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized, controlled clinical trial

Study Record Dates

• First Submitted: July 19, 2023
• First Posted: July 27, 2023
• Study Start: January 23, 2023
• Primary Completion: June 1, 2024
• Study Completion: September 1, 2024
• Last Updated: October 4, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)