NCT05773911

Brief Summary

In the here suggested study, the aim is to test non-surgical treatment of advanced periodontal disease with a chitosan brush with or without chitosan gel in patients with advanced periodontal disease having responded poorly to a more conventional treatment strategy, with the aim to hinder the progression of bone loss around the teeth.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

September 15, 2022

Completed
6 months until next milestone

First Posted

Study publicly available on registry

March 17, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

March 23, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

June 26, 2023

Status Verified

June 1, 2023

Enrollment Period

1.1 years

First QC Date

September 15, 2022

Last Update Submit

June 22, 2023

Conditions

PeriodontitisPeriodontal PocketPeriodontal DiseasesPeriodontal Inflammation

Keywords

PeriodontitisPeriodontal diseasePeriodontal pocket

Outcome Measures

Primary Outcomes (2)

  • Pocket Probing depths change

    Difference between test and control sites in Probing Pocket Depth (PPD)4 weeks , 3 months, 6, 9 and 12 months after baseline.

    12 months

  • Bleeding on Probing change

    Change in periodontal inflammation measured with the inflammation surrogate marker Bleeding on Probing using a categorial scale (modified Bleeding on Probing index (mBoP: 0, 1, 2, 3)) and

    12 months

Study Arms (2)

Test

EXPERIMENTAL

Curettes+ Ultrasonic scalers supragingivally and a chitosan brush in oscillating handpiece subgingivally with adjunct 4% chitosan gel (pH 3.48).

Device: 4% chitosan gel (pH 3.48).

Control

ACTIVE COMPARATOR

Curettes+ Ultrasonic scalers supragingivally and a chitosan brush in oscillating handpiece subgingivally

Device: Reciprocal Chitosan brush

Interventions

4% chitosan gel (pH 3.48).DEVICE

Reciprocal Chitosan brush with 4% chitosan gel (pH 3.48).

Also known as: Gelix
Test
Reciprocal Chitosan brushDEVICE

Reciprocal Chitosan brush

Also known as: Labrida BioClean
Control

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with at least 3 teeth but less than 8 teeth with advanced periodontal attachment loss.
  • Clinical Attachment Loss (CAL) ≥5 mm, probing pocket depth (PPD) ≥5mm and ≤8 mm and inflammation as demonstrated by a modified Bleeding on Probing (BoP) grade 2 (line) or 3 ("spontaneous").

You may not qualify if:

  • Ongoing radiotherapy, ongoing chemotherapy, pregnant or nursing patients, prosthetic factors making access to clinical measurements impossible
  • Poor oral hygiene with plaque at \>20% of the surfaces
  • Periodontal pockets reaching to the apex of teeth.
  • Teeth with active peri-apical pathology
  • Teeth with root resorption as seen on radiographs
  • Teeth with pockets from other reasons than periodontal disease
  • Patients diagnosed with Periodontal disease grade C i.e., rapid rate of progression
  • Sites in direct proximity with site(s) where patient places snuff (Copenhagen) will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bjerke tannmedisin

Oslo, 0286, Norway

RECRUITING

Related Publications (1)

  • Klein O, Balta MG, Wohlfahrt JC. Treatment of Residual Pockets in Stage III and IV Periodontitis Using an Oscillating Chitosan Device With or Without a Chitosan Gel-A Randomised Parallel-Arms Clinical Trial. J Clin Periodontol. 2026 Jan 22. doi: 10.1111/jcpe.70086. Online ahead of print.

    PMID: 41568740DERIVED

MeSH Terms

Conditions

PeriodontitisPeriodontal PocketPeriodontal Diseases

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Central Study Contacts

Johan C Wohlfahrt, PhD

CONTACT

+4747905629casparwohlfahrt@gmail.com

Maria Balta, DDS, MS

CONTACT

93980652maria.balta@odont.uio.no

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This efficacy study will be a prospective multicenter parallel arm, examiner blinded, randomized clinical trial of 12 months' duration.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of Research and Development

Study Record Dates

First Submitted

September 15, 2022

First Posted

March 17, 2023

Study Start

March 23, 2023

Primary Completion

April 23, 2024

Study Completion

December 31, 2024

Last Updated

June 26, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)