Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05773911 |
| Other study ID # |
219125 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 23, 2023 |
| Est. completion date |
December 31, 2024 |
Study information
| Verified date |
June 2023 |
| Source |
Labrida AS |
| Contact |
Johan C Wohlfahrt, PhD |
| Phone |
+4747905629 |
| Email |
casparwohlfahrt[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Labrida GeliX Chitosan gel 4% (LABRIDA AS, Oslo, Norway) is a chitosan gel. Labrida GeliX
Chitosan gel 4% consists of water, chitosan (4%) and lactic acid (2%) and with pH 3.86. In
this study GeliX Chitosan gel 4% shall be tested as an adjunct to mechanical debridement of
infected tooth surfaces affected by periodontal disease and which have responded poorly to
conventional treatment.
Hypotheses and study objectives
Null hypothesis and alternate hypothesis
H0:
There will be no significant difference in reduction in parameters of periodontal
inflammation between the test and control groups after 6 and 12 months.
HA:
There will be a significant difference in reduction in parameters of periodontal inflammation
between the test and control groups after 6 and 12 months.
Primary Objective Difference between test and control groups in change in inflammation tested
by measuring the surrogate markers Pocket Probing Depth (PPD) and Bleeding on Probing (BoP)
This will be done to assess the clinical efficacy of Labrida GeliX Chitosan gel 4% used in
combination with Labrida BioClean® for treatment of advanced periodontal disease (2017 World
Workshop Stage III and IV Grade B) Primary endpoint is reduction in periodontal disease as
measured clinically up to three months after therapy.
Secondary Objectives • Difference between test and control groups in change in periodontal
attachment loss tested by measuring clinical attachment loss (CAL) and bone level differences
on radiographs at baseline and 6 and 12 months. This will be done to assess safety of Labrida
GeliX Chitosan gel 4% used in combination with Labrida BioClean®, by evaluating the
occurrence of adverse events.
Design of clinical investigation
This efficacy study will be a prospective multicenter parallel arm, examiner blinded,
randomized clinical trial of 12 months' duration.
Patient screening, inclusions and all clinical examinations will be performed by a
board-certified specialist in periodontology at the test centers. Treatment will be performed
by a registered separate therapist, either dentist or dental hygienist.
Clinical variables of periodontal disease will be recorded at baseline, 1 week, 4 weeks and
at 3, 6, 9 and 12 months. Radiographs will be taken at baseline and at 6 and 12 months.
Treatment will be performed at baseline and thereafter at three months intervals.
Follow-up
- Intraoral radiographs will be taken at baseline and at 6 months to exclude progression
in bone loss.
- Post clinical data 4 weeks after treatment and 3, 6, and 9 months after treatment.
Objectives
Primary:
Primary endpoint is reduction in periodontal disease as measured clinically up to three
months after therapy.
Secondary:
• Evaluation of difference between test and control groups in change in periodontal
attachment loss tested by measuring clinical attachment loss (CAL) and bone level differences
on radiographs at baseline and 6 and 12 months.
Study financing The study is financed by the sponsor Labrida AS.
Enrollment and Randomization
Patients will be allocated to one of the following two treatments:
A) C+ USS supragingivally and a chitosan brush in oscillating handpiece subgingivally and
irrigation with sterile saline B) C+ USS supragingivally and a chitosan brush in oscillating
handpiece subgingivally with adjunct 4% chitosan gel (pH 3.86) and irrigation with sterile
saline followed by application of chitosan gel in the pockets.
A computer-generated block randomization will be used to ensure equal sample sizes.
Labrida GeliX Chitosan gel 4% used as an adjunct to non-surgical treatment with Labrida
BioClean® is the investigational device while the comparator in the control group is Labrida
BioClean® alone (CE 2460). No other device or medication will be used in the trial.
Subjects Target population 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.
Main inclusion criteria Patients with at least 3 teeth but less than 8 teeth with advanced
periodontal attachment loss (2017 World Workshop Stage III and IV Grade B), 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").
Total expected duration of the clinical investigation Study period Q2 2023 until Q2 2024
Expected duration of each subject participation 12 months
Patients 40 patients diagnosed with advanced periodontitis will be included. 20 patients will
be treated with the control treatment (the chitosan brush), 20 patients will be treated with
the test treatment (chitosan brush with chitosan gel).
Details of measures to be taken to minimize bias Bias will be avoided through double blinding
and randomization. Confounding factors will be avoided through inclusion criteria and
randomization.
Clinical procedures and diagnostic methods
Preoperative evaluation Clinical and radiographic evaluation including periodontal and
general dental status. The radiographic evaluation includes intraoral radiography with apical
radiographs and vertical bitewings on molars and premolars. Clinical screening includes
routine history and physical examination, admission criteria, signed informed consent and
pain assessments.
The full-mouth plaque index using dichotomous scoring shall be below 20% prior to final
inclusion.
Clinical procedure 1) Full mouth supragingival debridement to remove supragingival visual
calculus will be performed with hand curettes and ultrasonic scaler
Subgingival debridement after randomization to test or control group:
2 A) Control group: The periodontal pockets in the patients in the control group will be
treated with C+ USS supragingivally and a chitosan brush in an oscillating handpiece (NSK
ER10 + TEQ-Y) subgingivally for 2 minutes. Thereafter irrigation using sterile saline.
2 B) Test group: The periodontal pockets in the patients in the test group will be treated
with C+ USS supragingivally and a chitosan brush in oscillating handpiece subgingivally with
adjunct 4% chitosan gel subgingivally (pH 3.86) and irrigation using sterile saline. and
application of the chitosan gel into the pockets A computer-generated block randomization
will be used to ensure equal sample sizes.
The treatments will be repeated every three months and the terminal examination will be at 12
months. All treatments will be performed by a registered dental hygienist. All examinations
will be performed by a board certified periodontist other than the sponsor. The sponsor
representative will not have an active role in the study other than screening of patients and
monitoring of the study.
Prophylaxis Endodontic lesions, prosthetic complications and dental decay should be treated
before study start. Plaque Index (dichotomous scoring) should be ≤20%.
Examinations Medical history will be carefully recorded prior to examination. Clinical
variables of inflammation will be measured at baseline and 4 weeks, 12 weeks 6, 9 and 12
months after baseline.
Non-invasive sampling of gingival crevicular fluid from the tooth crevice at baseline and one
and 4 weeks will be undertaken and used for analysis of changes in inflammatory markers after
treatment.
Probing pocket depths will be recorded at 6 sites (mesio-buccally, buccaly, disto-buccally,
disto-palataly, palataly, mesio-palataly) around each included tooth using a regular
periodontal probe according to the examiner's preferences. Bleeding on probing at the
included sites will be assessed using a three-graded index within 30 seconds following
probing of the pocket using a modified bleeding on probing index (mBoP) (28). Suppuration at
the included sites will be recorded using dichotomous scoring. CAL (ECJ to base of pocket)
will be recorded at 6 sites per included tooth at baseline and at 6 and 12 months. Furcations
will be recorded (Hampf 0, I, II, III). Mobility will be recorded (Miller 0,1,2,3). Plaque at
the included teeth and for the full dentition, will also be assessed using dichotomous
scoring. Radiographs will be taken at baseline and at 12 months.
Copies of informed consents and radiographs will be stored at each center, according to GCP -
guidelines.
Routine history and physical examination will be performed, and information recorded in the
Preoperative Patient History Record. The therapist may use his/her customary history and
physical procedures; however, all data specified on the Preoperative Patient History Record
will be recorded in the Case Report Form (CRF). Exclusion Criteria are also included in the
form. Entries checked YES will exclude patients from admission into the study.
Peroperative procedures (At the time of the treatment) Treatment approach and technique will
be carried out according to a standardized procedure agreed upon between the participating
therapists.
POSTOPERATIVE FOLLOW-UP PROCEDURES All postoperative evaluations (Clinical examination (CAL,
PLI, BoP, PPD, pus)) will be recorded on regular patient record and later transferred to the
Case Report Form. Furthermore, intraoral radiographs will be taken at baseline and at 6
months to exclude progression in bone loss.
Clinical complications such as infection, pain etc. will be recorded during all postoperative
follow-up visits, should they occur.
The GCF samples will be stored in a dedicated project biobank at the Institute of oral
biology (Dr Maria Balta will be responsible for the project biobank) until all patients has
undergone the 4 weeks control and thereafter sent to University of Minnesota, USA for Mass
spectrometry-based metabolomics analysis of changes in some metabolites involved in the
inflammation and treatment response between baseline and 1 week and 4 weeks. A wide range of
metabolites involved in the inflammatory response will be included in the analyses.
Metabolites involved in degradation of chitosan will also be analysed for. Professor Massimo
Costalonga, University of Minnesota will be responsible for the analyses. Any remaining
biologic material will be destroyed.
Statistical consideration Sample size If a PPD difference in the change of PPD between
methods of 1 mm is to be detected at a=0.05 and a power of = 0.2, the appropriate number of
subjects per group would be 20. Hence, the inclusion of 40 subjects in the study would yield
the necessary statistical power.
Statistical evaluation After completion of the study, the statistical analysis will be
performed by the principal investigators in collaboration with a biostatistician.
A two-sided statistical test will be used since both positive and potential negative outcomes
will be evaluated. Sigma Stat will be used. All data will be transferred from the CRF to
Sigma Stat files. The statistical computations will be cross checked with a professional
biostatistician.
The report will form the basis for the Clinical Investigation Report and a manuscript
intended for publication in a dental peer reviewed scientific journal.
Ethics Committee Approval The study has been accepted by the Regional Ethical Review board
.
