NCT05162417

Brief Summary

Dental biofilm is a primary etiological factor for periodontal diseases.(1) The bacterial biofilm would induce recruitment of leucocytes, neutrophils, and T lymphocytes and the secretion of antibodies, lipopolysaccharides, and chemical inflammatory mediators such as cytokines and chemokines.(2) Thus, periodontal diseases can cause tissue destruction and results in deterioration of clinical parameters measures such as periodontal pockets depth, clinical attachment loss, bleeding on probing, bone destruction, and resulting ultimately in tooth loss.(3)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2021

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

November 29, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 17, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

12 months

First QC Date

November 29, 2021

Last Update Submit

November 27, 2023

Conditions

Periodontal DiseasesPeriodontal Pocket

Keywords

Probing Pocket depthphhotosensitizers

Outcome Measures

Primary Outcomes (2)

  • Change in probing pocket depth

    millimetre

    At the base line and three months

  • Change in clinical attachment loss

    millimeter

    At the base line and three months

Secondary Outcomes (1)

  • Change in bleeding on Probing

    at base line and 3 month

Study Arms (3)

Control group

NO INTERVENTION

patient in this arm will receive scaling and root planning treatment only.

Test group (toluidine Blue O)

EXPERIMENTAL

patients in this arm will receive Toluidine Blue O as an adjunctive to scaling and root planing.

Other: Toluidine Blue O

Methylene blue

EXPERIMENTAL

Patients will receive Methylene blue as adjunctive to scaling and root planning.

Other: Methylene Blue

Interventions

Methylene BlueOTHER

1mg/ml of Methylene as a solution will be used two times, first immediately after scaling and root planning, second after two weeks of the first treatment.

Methylene blue
Toluidine Blue OOTHER

1mg/ml of Toluidine blue o as a solution will be used two times, first immediately after scaling and root planning, second after two weeks of the first treatment.

Test group (toluidine Blue O)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Each patient should have at least four teeth with a probing depth ≥of 5mm.
  • Patients with good domestic oral hygiene will be include (documented with a full mouth plaque index of ≤ 30% before starting the clinical trial)

You may not qualify if:

  • Patients receiving periodontal therapy and/or antibiotics within the previous six months
  • Patients with diseases or medication with an inhibitory or promoting effect on periodontal healing, including anticoagulants, anti-inflammatories.
  • Pregnant or nursing women
  • Patients allergic to the test product will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

College of Dentistry, University of Sulaimani

Sulaymaniyah, 46001, Iraq

Location

Related Publications (9)

  • Larsen T, Fiehn NE. Dental biofilm infections - an update. APMIS. 2017 Apr;125(4):376-384. doi: 10.1111/apm.12688.

    PMID: 28407420BACKGROUND

  • Cekici A, Kantarci A, Hasturk H, Van Dyke TE. Inflammatory and immune pathways in the pathogenesis of periodontal disease. Periodontol 2000. 2014 Feb;64(1):57-80. doi: 10.1111/prd.12002.

    PMID: 24320956BACKGROUND

  • Kinane DF, Stathopoulou PG, Papapanou PN. Periodontal diseases. Nat Rev Dis Primers. 2017 Jun 22;3:17038. doi: 10.1038/nrdp.2017.38.

    PMID: 28805207BACKGROUND

  • Shrivastava D, Natoli V, Srivastava KC, Alzoubi IA, Nagy AI, Hamza MO, Al-Johani K, Alam MK, Khurshid Z. Novel Approach to Dental Biofilm Management through Guided Biofilm Therapy (GBT): A Review. Microorganisms. 2021 Sep 16;9(9):1966. doi: 10.3390/microorganisms9091966.

    PMID: 34576863BACKGROUND

  • Khattri S, Kumbargere Nagraj S, Arora A, Eachempati P, Kusum CK, Bhat KG, Johnson TM, Lodi G. Adjunctive systemic antimicrobials for the non-surgical treatment of periodontitis. Cochrane Database Syst Rev. 2020 Nov 16;11(11):CD012568. doi: 10.1002/14651858.CD012568.pub2.

    PMID: 33197289BACKGROUND

  • Carrera ET, Dias HB, Corbi SCT, Marcantonio RAC, Bernardi ACA, Bagnato VS, Hamblin MR, Rastelli ANS. The application of antimicrobial photodynamic therapy (aPDT) in dentistry: a critical review. Laser Phys. 2016 Dec;26(12):123001. doi: 10.1088/1054-660X/26/12/123001. Epub 2016 Nov 9.

    PMID: 29151775BACKGROUND

  • Kharkwal GB, Sharma SK, Huang YY, Dai T, Hamblin MR. Photodynamic therapy for infections: clinical applications. Lasers Surg Med. 2011 Sep;43(7):755-67. doi: 10.1002/lsm.21080.

    PMID: 22057503BACKGROUND

  • Kashef N, Huang YY, Hamblin MR. Advances in antimicrobial photodynamic inactivation at the nanoscale. Nanophotonics. 2017 Aug;6(5):853-879. doi: 10.1515/nanoph-2016-0189. Epub 2017 Aug 1.

    PMID: 29226063BACKGROUND

  • Liu Y, Qin R, Zaat SAJ, Breukink E, Heger M. Antibacterial photodynamic therapy: overview of a promising approach to fight antibiotic-resistant bacterial infections. J Clin Transl Res. 2015 Dec 1;1(3):140-167. eCollection 2015 Dec 30.

    PMID: 30873451BACKGROUND

Related Links

MeSH Terms

Conditions

Periodontal DiseasesPeriodontal Pocket

Interventions

Methylene BlueTolonium Chloride

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesPeriodontitis

Intervention Hierarchy (Ancestors)

PhenothiazinesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Sarhang S. Gul, PhD

    College of Dentistry, University of Sulaimani

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

November 29, 2021

First Posted

December 17, 2021

Study Start

November 15, 2021

Primary Completion

November 1, 2022

Study Completion

April 1, 2023

Last Updated

November 29, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share

The data will be available upon reasonable request following publication by principal investigators

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
1 year
Access Criteria
The data will be available upon reasonable request.
More information

Locations

IR(1)