Sodium hypochlorite formulation as an adjunct to nonsurgical periodontal treatment

ISRCTN	ISRCTN11287170
DOI	https://doi.org/10.1186/ISRCTN11287170
Secondary identifying numbers	Medical University of Bialystok : SUB/1/DN/20/003/1164

Submission date: 10/06/2025
Registration date: 22/07/2025
Last edited: 22/07/2025

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Oral Health

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Periodontitis is a chronic inflammatory disease leading to the bone and soft tissue loss and, consequently, to tooth loss. Scaling and root planing (SRP) is the basic therapeutic procedure in the treatment of periodontitis. Due to the limitations of SRP and the multifactorial etiology of periodontal disease, new methods are being sought to support mechanotherapy. One of them is the local use of antiseptics such as low-concentration sodium hypochlorite formulation.
Therefore, the aim of the study was to clinically evaluate periodontal
parameters and take the samples of the gingival crevicular fluid after SRP with intrapocket application of a new preparation with low-concentrated sodium hypochlorite and without the use of the formulation.

Who can participate?
Adults (18+ years) with periodontitis.

What does the study involve?
The study involves scaling and root planing with and without sodium hypochlorite formulation. Before SRP, the patients in the study group will have a gel with low-concentration sodium hypochlorite introduced into pockets with depth over 5 mm. The patients in the control group will have SRP alone. Clinical examination of periodontium will be done and gingival crevicular fluid will be taken to further analysis.

What are the possible benefits and risks of participating?
Possible benefit of participating is decrease in periodontal pocket depth.
Possible risks are the same as routine dental visit. The low concentration sodium hypoclorite formulation will be used according manufacturer instructions.

Where is the study run from?
Study is run at Medical University of Bialystok (Poland)

When is the study starting and how long is it expected to run for?
January 2020 to May 2022

Who is funding the study?
The study is funded by Medical University of Bialystok (Poland)

Who is the main contact?
The main contact is Dr hab. n. med Ewa Dolińska (ewa.dolinska@umb.edu.pl)

Contact information

Dr Ewa Dolińska
Public, Scientific, Principal Investigator

ul.Waszyngtona 13
Białystok
15-269
Poland

ORCID ID	0000-0003-3122-4990
Phone	+48 857485905
Email	ewa.dolinska@umb.edu.pl

Study information

Study design	Interventional single-blinded randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Dental clinic
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details to request a prticipant information sheet.
Scientific title	Sodium hypochlorite formulation as an adjunct to nonsurgical periodontal treatment-a prospective randomized clinical trial
Study objectives	There are no clinical differences between non-surgical periodontal treatment and non-surgical periodontal treatment preceded by application of a sodium hypochlorite-based formulation.
Ethics approval(s)	Approved 23/09/2020, Bioethics Committee of Medical University of Bialystok (ul. Kilińskiego 1, Białystok, 15-089, Poland; 85 748 54 07; komisjabioetyczna@umb.edu.pl), ref: APK.002.269.2020
Health condition(s) or problem(s) studied	Nonsurgical periodontal treatment
Intervention	Patients are randomly allocated to study or control group. Randomization is based on a computer-generated list. Patients randomized to the study group are treated non-surgically (SRP, scaling and root planing) according to the following procedure: after a periodontal examination, a preparation with NaOCl/AA (Perisolv®) is applied into the pockets with PD ≥ 5 mm. The formulation is prepared immediately before application by mixing the contents of two syringes. A gel is introduced into the pockets with PD≥5mm with a sterile applicator. The gel is left in place for 30 seconds. This is followed by a total subgingival scaling and root planing using an EMS Piezon ultrasonic scaler (EMS) with a PS tip (Perio Slim). In the control group, the SRP procedure is performed with the same instruments without Perisolv® application. Clinical examination is planned at baseline, 3 months and 6 months. Gingival crevicular fluid collection is planned 1 week, 2weeks, 3 months and 6 months.
Intervention type	Mixed
Primary outcome measure	1. Probing depth (PD) is measured using a manual PCP UNC 15 periodontal probe (Hu-Friedy, Chicago, IL, USA), calibrated in 1 milimeter increments at baseline, 3 months and 6 months. 2. Number of deep periodontal pockets i.e. pockets with PD ≥ 5 mm is counted at baseline, 3 months and 6 months. Pockets that were PD ≥ 5 mm at baseline and become PD <5mm are counted as ‘closed’ pockets.
Secondary outcome measures	1. Clinical attachment level gain (CAL) and gingival recession (GR) are measured using a manual PCP UNC 15 periodontal probe (Hu-Friedy, Chicago, IL, USA), calibrated in 1 milimeter increments at baseline, 3 months and 6 months. 2. Full mouth plaque score (FMPS) is measured using manual PCP UNC 15 periodontal probe (Hu-Friedy, Chicago, IL, USA), calibrated in 1 milimeter increments at baseline, 3 months and 6 months. Presence of plaque is checked on 6 surfaces of each tooth. 3. Full mouth bleeding on probing (FMBOP) is measured using a manual PCP UNC 15 periodontal probe (Hu-Friedy, Chicago, IL, USA), calibrated in 1 milimeter increments at baseline, 3 months and 6 months. Bleeding on probing is assesed in 6 points on every tooth. 4. Additionally at baseline, 1 week, 2 weeks, 3 months and 6 months gingival crevicular fluid is taken for labolatory analyses.
Overall study start date	10/01/2020
Completion date	05/05/2022

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	40
Total final enrolment	40
Key inclusion criteria	1. Diagnosed with periodontitis stage II or III, grade B or C 2. Presence of at least 16 teeth (with at least 4 in each quadrant) 3. Presence of at least 4 deep periodontal pockets (PD ≥ 5 mm) 4. No professional hygiene procedures in the last 6 months 5. No systemic antibiotic therapy in the last 3 months 6. Age over 18 years 7. Being a non-smoker
Key exclusion criteria	1. General contraindications to any periodontal therapy 2. Immunosuppression or immunological incompetence 3. Uncontrolled diabetes 4. Pregnancy and breastfeeding 5. Alcohol and/or drug dependence 6. Patient requiring antibiotic cover prior to periodontal therapy 7. Patient with no opportunity to participate in the programme for 6 months
Date of first enrolment	01/10/2020
Date of final enrolment	30/09/2021

Locations

Countries of recruitment

Poland

Study participating centre

Department of Periodontal and Oral Mucosa Diseases, Medical University of Bialystok

ul Waszyngtona 13
Bialystok
15-269
Poland

Sponsor information

Medical University of Białystok
University/education

ul Kilińskiego 1
Bialystok
15-089
Poland

Phone	+48 85 7485400
Email	kancelaria@umb.edu.pl
Website	https://www.umb.edu.pl
"ROR"	https://ror.org/00y4ya841

Funders

Funder type

University/education

Medical University of Białystok

No information available

Results and Publications

Intention to publish date	01/09/2025
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Planned publication in a peer-reviwed journal.
IPD sharing plan	The datasets generated during this study are available upon reasonable request from Ewa Dolińska (ewa.dolinska@umb.edu.pl).

Editorial Notes

17/06/2025: Trial's existence confirmed by Medical University of Bialystok.