Evaluation of Hydrogel Application in the Treatment of Periodontitis and Peri-implantitis

Summary

To date, systemic/local antibiotics, antimicrobials, laser application, and probiotics have been used as adjuncts to improve the outcome of non-surgical periodontal treatment for both periodontitis and peri-implantitis patients. H42® hydrogel, obtained by combining a high molecular weight hydrogel with type I collagen, is a collagen paste for regenerating periodontal/peri-implant pockets caused by periodontitis/peri-implantitis. This study aimed to clinically, biochemically, and radiologically evaluate the effect and reliability of hydrogel application into the pocket in addition to non-surgical periodontal treatment in the treatment of periodontal and peri-implant pockets.

Fifteen patients with stage 2 periodontitis, each with 30 teeth and 30 implants with 5-8 mm pocket depth in the contralateral quadrants, and a total of 30 patients, will be equally divided into two groups. The test group will receive non-surgical periodontal treatment followed by H42 hydrogel application (Hydrogel Oral- 3 syr 0.4 cc/syr), while the control group will receive only non-surgical periodontal treatment. All patients will undergo the same procedure of non-surgical periodontal treatment

Conditions

• Periodontal Disease Stage 2
• Peri-Implantitis and Peri-implant Mucositis
• Periodontal Regeneration

Interventions

PROCEDURE

Nonsurgical periodontal treatment and application of H42® hydrogel to the peri-implant pocket

Firstly, after appropriate oral hygiene training, full mouth supragingival scaling will be performed using an ultrasonic device (EMS Piezon ultrasonic system, EMS Electro Medical Systems, Switzerland). Non-surgical periodontal treatment will be completed after subgingival curettage of peri-implant pocket areas between 5-8 mm in the contralateral quadrant. The tested site will be partially isolated and then air-dried. A bent, blunt-tipped needle syringe will be used to inject the H42® hydrogel into the pocket, ensuring that the tip reaches the deepest point of the pocket. Once the gel is visible at the gingival margin, the needle will be gently removed from the pocket. After approximately 0.1 mL of gel has been applied, excess gel will be removed with a sterile gauze swab to prevent any spreading effect or possible systemic effect. After application of the H42 hydrogel, the area will be kept dry for 5 minutes to ensure optimum adhesion of H42 to the pocket tissue.

PROCEDURE

Nonsurgical periodontal treatment of periodontal pocket

Systemic and dental anamnesis will be taken from all patients. Firstly, after appropriate oral hygiene education, full mouth supragingival scaling will be performed using an ultrasonic device (EMS Piezon ultrasonic system, EMS Electro Medical Systems, Switzerland). Non-surgical periodontal treatment will be completed after subgingival curettage of periodontal pocket areas between 5-8 mm in the contralateral quadrant.

PROCEDURE

Non-surgical periodontal treatment and application of H42® hydrogel to the periodontal pocket

Firstly, after appropriate oral hygiene training, full mouth supragingival scaling will be performed using an ultrasonic device (EMS Piezon ultrasonic system, EMS Electro Medical Systems, Switzerland). Non-surgical periodontal treatment will be completed after subgingival curettage of periodontal pocket areas between 5-8 mm in the contralateral quadrant. The tested site will be partially isolated and then air-dried. A bent, blunt-tipped needle syringe will be used to inject the H42® hydrogel into the pocket, ensuring that the tip reaches the deepest point of the pocket. Once the gel is visible at the gingival margin, the needle will be gently removed from the pocket. After approximately 0.1 mL of gel has been applied, excess gel will be removed with a sterile gauze swab to prevent any spreading effect or possible systemic effect. After application of the H42 hydrogel, the area will be kept dry for 5 minutes to ensure optimum adhesion of H42 to the pocket tissue.

PROCEDURE

Nonsurgical periodontal treatment of peri-implant pocket

Systemic and dental anamnesis will be taken from all patients. Firstly, after appropriate oral hygiene education, full mouth supragingival scaling will be performed using an ultrasonic device (EMS Piezon ultrasonic system, EMS Electro Medical Systems, Switzerland). Non-surgical periodontal treatment will be completed after subgingival curettage of peri-implant pocket areas between 5-8 mm in the contralateral quadrant.

Sponsors & Collaborators

• Kutahya Health Sciences University

  lead OTHER

Principal Investigators

• Berceste Güler Ayyıldız, Assoc. Prof. Dr · Kütahya Health Sciences University

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-06-01

Primary Completion

2026-01-01

Completion

2026-03-01

Countries

• Turkey (Türkiye)

Study Locations