Nonsurgical approach for the treatment of periodontal diseases

ISRCTN	ISRCTN29615137
DOI	https://doi.org/10.1186/ISRCTN29615137
Sponsor	Astra Science LLC
Funder	Yerevan State University

Submission date: 28/12/2025
Registration date: 30/12/2025
Last edited: 30/12/2025

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Plain English summary of protocol not provided at time of registration.

Contact information

Prof Gagik Hakobyan
Public

Kievyan 10/65
Yerevan
0025
Armenia

Phone	+37491403038
Email	prom_hg@yahoo.com

Prof Lazar Yessayan
Scientific

2 Koryuni
Yerevan
0025
Armenia

Phone	+37494422222
Email	lasyes@yandex.ru

Mr Viktoria Margaryan
Principal investigator

2 Koryuni
Yerevan
0028
Armenia

Phone	+374033352050
Email	viki199813@mail.ru

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Blinded (masking used)
Control	Active
Assignment	Parallel
Purpose	Treatment
Scientific title	Adjunctive therapy – a promising method in the treatment of periodontal disease
Study objectives	The study aims to compare the clinical efficacy of the application of "Armenicum" paste as an adjunct to SRP for the non‐surgical treatment of patients with periodontitis.
Ethics approval(s)	Approved 22/01/2025, Yervan State Medical University (Koryun 2, Yerevan, 0025, Armenia; +374 10 58 25 32; info@ysmu.am), ref: 24
Health condition(s) or problem(s) studied	Periodontitis according to the World Classifications of 2017.
Intervention	The patients were randomly assigned into two groups using computer-generated randomisation: Group A (SRP + Armenicum" paste) and Group B (SRP). Group A underwent a periodontal treatment which included: supragingival and subgingival scaling, and additional use of local "Armenicum" paste. Under local anesthesia, supragingival and subgingival scaling(with an ultrasonic scaler and root planning using Gracey curettes). Immediately after (SRP), the teeth were isolated with cotton rolls and the paste "Armenicum" paste was gently applied once with a syringe inside the pocket and the top of the gum area. Within 3 h of applying the paste, patients were advised not to eat, drink or brush their teeth. "Armenicum" was applied for ten days under a bandage on the gums for 10 procedures lasting thirty minutes. The Group B group only received supragingival and subgingival scaling. Group B protocol periodontal treatment includes: supragingival and subgingival scaling and root debridement (with an ultrasonic device and root planning using Gracey curettes). The therapy was also performed under local anesthesia. Patients were instructed to start rinsing 24 h after therapy with a 0.12% chlorhexidine solution for 2 weeks, twice daily. After comprehensive treatment of periodontitis, all patients had assessments and were indexed: (1) dental plaque index (PI); (2) bleeding on probing (BOP); (3) probing pocket depth (PPD).
Intervention type	Supplement
Primary outcome measure(s)	The amount and thickness of bacterial plaque on tooth surfaces measured using the Dental plaque index (PI) at baseline, 3 and 6 months Bleeding on probing (BOP) measured using the BOP index following an examination after 30 s of each probed site at baseline, 3 and 6 months Probing pocket depth (PPD) measured using a full millimeter with a manual periodontal probe between the gingival margin and the base of the periodontal pocket, 6 sites per tooth (mesio-buccal, midbuccal, disto-buccal, mesio-palatal, mid-palatal, and disto-palatal) at baseline, 3 and 6 months Gum inflammation measured using the gingival bleeding index at baseline, 3 and 6 months
Key secondary outcome measure(s)
Completion date	28/12/2025

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	37 Years
Upper age limit	68 Years
Sex	All
Target sample size at registration	157
Total final enrolment	157
Key inclusion criteria	1. Stage I or stage II of chronic periodontitis 2. A minimum of 24 remaining teeth 3. Non-smokers 4. Systemically healthy 5. Not received any previous periodontal treatment (within the previous year) 6. No antibiotic therapy or chemotherapeutic mouth-rinse or oral irrigation (within the last 6 months) 7. Can perform oral hygiene self-care and are committed to post-treatment follow-up visits
Key exclusion criteria	1. Systemic diseases 2. Smokers 3. Pregnant and lactating females 4. Previous periodontal treatment (during the previous year) or antibiotic intake (during the past 3 months)
Date of first enrolment	28/01/2025
Date of final enrolment	28/07/2025

Locations

Countries of recruitment

Armenia

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		23/01/2025	30/12/2025	Yes	No

Editorial Notes

30/12/2025: Study’s existence confirmed by Astra Science LLC.