Ignite Creation Date:
2025-12-18 @ 8:15 AM
Ignite Modification Date:
2025-12-18 @ 8:15 AM
Study NCT ID:
NCT06740123
Status:
None
Last Update Posted:
2024-12-18 00:00:00
First Post:
2024-11-27 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Hydrogel Application in the Treatment of Periodontitis and Peri-implantitis
Sponsor:
None
Organization:
Study Overview
Official Title:
Clinical, Radiological, and Biochemical Evaluation of Adjunctive Hydrogel Application in the Non-Surgical Treatment of Peri-implantitis and Periodontitis
Status:
None
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Periodontitis is a chronic, multifactorial, inflammatory disease associated with biofilm and characterized by the destruction of the bone supporting the tooth. Peri-implantitis is an inflammatory disease associated with inflammation of the peri-implant mucosa followed by progressive bone destruction of varying degrees, with a peri-implant pocket depth of at least 4 mm, accompanied by symptoms such as bleeding and suppuration. Peri-implantitis and periodontitis have similar microbial flora, but peri-implantitis is more complex. In periodontitis and peri-implantitis patients, adjunctive therapies are needed to support non-surgical treatment and to strengthen the immune system by suppressing periodontal pathogens. Adjunctive therapies include local and systemic antibiotics, laser applications, antimicrobials, probiotics, photodynamic therapy, host-modulating agents, enamel matrix protein, injectable platelet-rich fibrin, hyaluronic acid gel, and other medications. H42® hydrogel, obtained by combining a high molecular weight hydrogel with type I collagen; It is an applied collagen paste that helps non-surgical periodontal treatment of periodontal and peri-implant diseases with its physical, bio-chemical, and rheological properties. The plugging effect and visco-elasticity of the hydrogel limits bacterial recolonisation after the use of mechanical instruments in periodontal/peri-implant pockets and allow the regeneration of periodontal/peri-implant pockets caused by periodontitis/peri-implantitis. When the H42® hydrogel is applied to the affected area, it physically moves away from the implant site over a period of 15-30 days and does not need to be removed from the application site.
To evaluate clinically, biochemically and radiologically the effect and reliability of hydrogel application into the pocket in addition to non-surgical periodontal treatment in the treatment of periodontitis/peri-implantitis patients with periodontal/peri-implant pockets between 5-8 mm contralaterally.
A total of 30 patients, including 15 systemically healthy patients older than 18 years of age, with Stage 2 periodontitis and periodontal/peri-implant pockets between 5-8 mm on the contralateral side, who applied to Kütahya Health Sciences University, Faculty of Dentistry, Department of Periodontology, will be included in the study.
Study group periodontal pockets: Thirty teeth in 15 patients with stage 2 periodontitis with 5-8 mm pocket depth in the contralateral quadrants will be equally divided into two groups.
Group I (Test Group) (number of pockets = 15): Will be treated with nonsurgical periodontal treatment and intrapocket H42 hydrogel application.
Group II (Control Group) (number of pockets = 15): Will be treated with nonsurgical periodontal treatment only.
Study group peri-implant pockets:Thirty implants in 15 patients with stage 2 periodontitis with 5-8 mm pocket depth in the contralateral quadrants will be equally divided into two groups.
Group III (Test Group) (number of pockets = 15): Will be treated with nonsurgical periodontal treatment and intrapocket H42 hydrogel application.
Group IV (Control Group) (number of pockets = 15): Will be treated with nonsurgical periodontal treatment only.
All patients will be randomly allocated to study groups using the sealed envelope method. 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 (scaling and subgingival curettage treatment) with ultrasonic instrument (EMS Piezon ultrasonic system, EMS Electro Medical Systems, Switzerland). Non-surgical periodontal treatment will be completed after subgingival curettage of periodontal or peri-implant pocket sites between 5-8 mm in the contralateral quadrant. For the test group only, the tested site will be partially isolated and then air-dried. A bent, blunt-tipped needle syringe will be used to inject the hydrogel (H42) into the pocket, ensuring that the tip is inserted into 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 as a result of swallowing the gel. After application of the H42 hydrogel, the site will be kept dry for 5 minutes to ensure optimum adhesion of H42 to the pocket tissue. Patients will be advised to practice normal oral hygiene with no restrictions on dietary habits and to check for any re-infection. Periodontal clinical measurements (plaque index, gingival index, clinical attachment loss, bleeding index on probing and pocket depth) will be recorded at all implant and natural tooth sites with a pre-calibrated graduated William periodontal probe by a single clinician at baseline, 1 month, and 3 months after treatment. For biochemical evaluation, gingival crevicular fluid samples will be collected from the deepest pocket depth sites of all patients, from the test and control groups, at baseline, 1 month, and 3 months after treatment. The preferred time for collecting gingival crevicular fluid samples will be between 09:00-14:00. Gingival crevicular fluid samples will be collected from the mesial, distal, buccal and lingual surfaces of teeth or implants using standard-sized paper strips. The areas to be sampled will be isolated and the teeth will be lightly dried. The previously prepared paper strips placed in the pockets will be advanced until resistance is felt in the sulcus and will be kept in the pocket for 30 seconds. The gingival crevicular fluid samples obtained will be analyzed for IL-6, Prostaglandin E2 and IL-1 beta and TNF-alpha by ELISA. Periodontal radiographic evaluation will be performed on periapical x-rays taken with parallel technique from the relevant implant and tooth area before treatment and at 3-month follow-up. In addition, a 3D cone beam computed tomography image will be obtained to understand the shape of the bone destruction defect around the relevant tooth and implant and to measure the amount of bone filling 6 months after treatment.
To evaluate clinically, biochemically and radiologically the effect and reliability of hydrogel application into the pocket in addition to non-surgical periodontal treatment in the treatment of periodontitis/peri-implantitis patients with periodontal/peri-implant pockets between 5-8 mm contralaterally.
A total of 30 patients, including 15 systemically healthy patients older than 18 years of age, with Stage 2 periodontitis and periodontal/peri-implant pockets between 5-8 mm on the contralateral side, who applied to Kütahya Health Sciences University, Faculty of Dentistry, Department of Periodontology, will be included in the study.
Study group periodontal pockets: Thirty teeth in 15 patients with stage 2 periodontitis with 5-8 mm pocket depth in the contralateral quadrants will be equally divided into two groups.
Group I (Test Group) (number of pockets = 15): Will be treated with nonsurgical periodontal treatment and intrapocket H42 hydrogel application.
Group II (Control Group) (number of pockets = 15): Will be treated with nonsurgical periodontal treatment only.
Study group peri-implant pockets:Thirty implants in 15 patients with stage 2 periodontitis with 5-8 mm pocket depth in the contralateral quadrants will be equally divided into two groups.
Group III (Test Group) (number of pockets = 15): Will be treated with nonsurgical periodontal treatment and intrapocket H42 hydrogel application.
Group IV (Control Group) (number of pockets = 15): Will be treated with nonsurgical periodontal treatment only.
All patients will be randomly allocated to study groups using the sealed envelope method. 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 (scaling and subgingival curettage treatment) with ultrasonic instrument (EMS Piezon ultrasonic system, EMS Electro Medical Systems, Switzerland). Non-surgical periodontal treatment will be completed after subgingival curettage of periodontal or peri-implant pocket sites between 5-8 mm in the contralateral quadrant. For the test group only, the tested site will be partially isolated and then air-dried. A bent, blunt-tipped needle syringe will be used to inject the hydrogel (H42) into the pocket, ensuring that the tip is inserted into 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 as a result of swallowing the gel. After application of the H42 hydrogel, the site will be kept dry for 5 minutes to ensure optimum adhesion of H42 to the pocket tissue. Patients will be advised to practice normal oral hygiene with no restrictions on dietary habits and to check for any re-infection. Periodontal clinical measurements (plaque index, gingival index, clinical attachment loss, bleeding index on probing and pocket depth) will be recorded at all implant and natural tooth sites with a pre-calibrated graduated William periodontal probe by a single clinician at baseline, 1 month, and 3 months after treatment. For biochemical evaluation, gingival crevicular fluid samples will be collected from the deepest pocket depth sites of all patients, from the test and control groups, at baseline, 1 month, and 3 months after treatment. The preferred time for collecting gingival crevicular fluid samples will be between 09:00-14:00. Gingival crevicular fluid samples will be collected from the mesial, distal, buccal and lingual surfaces of teeth or implants using standard-sized paper strips. The areas to be sampled will be isolated and the teeth will be lightly dried. The previously prepared paper strips placed in the pockets will be advanced until resistance is felt in the sulcus and will be kept in the pocket for 30 seconds. The gingival crevicular fluid samples obtained will be analyzed for IL-6, Prostaglandin E2 and IL-1 beta and TNF-alpha by ELISA. Periodontal radiographic evaluation will be performed on periapical x-rays taken with parallel technique from the relevant implant and tooth area before treatment and at 3-month follow-up. In addition, a 3D cone beam computed tomography image will be obtained to understand the shape of the bone destruction defect around the relevant tooth and implant and to measure the amount of bone filling 6 months after treatment.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: