Evaluation of Hydrogel Application in the Treatment of Periodontitis and Peri-implantitis
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
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.
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.
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.
Study 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
Eligibility
Primary outcome measure(s)
- Periodontal or peri-implant pocket depth — 3-month follow-up of all implants and teeth
The primary outcome was the distance between the base of the periodontal sulcus and the gingival margin measured with a standard periodontal probe at 3-month follow-up. - Proinflammatory markers — 3-month follow-up of all implants and teeth
Gingival crevicular fluid samples are analyzed for proinflammatory markers IL-6, Prostaglandin E2 and IL-1 beta and TNF-alpha using the ELISA method at 3-months follow-up. - Marginal bone level change — 6-month follow-up of all implants and teeth
The primary outcome was measurement of marginal bone level on periapical radiographs and cone-beam computed tomography at 6-month follow-up.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Kütahya Health Sciences University Faculty of Dentistry | Kütahya | Turkey (Türkiye) |
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06740123 on ClinicalTrials.gov ↗ ← All trials in Turkey