Evaluation of Hydrogel Application in the Treatment of Periodontitis and Peri-implantitis
NCT ID: NCT06740123
Last Updated: 2024-12-18
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
NA
30 participants
INTERVENTIONAL
2024-06-01
2026-03-01
Brief Summary
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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
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Periodontal pocket (Test group)
To be treated with non-surgical periodontal treatment and intra-pocket H42 hydrogel application.
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.
Periodontal pocket (Control group)
To be treated with non-surgical periodontal treatment only
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.
Peri-implant pocket (Test group)
Will be treated with non-surgical periodontal treatment and intra-pocket H42 hydrogel application.
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.
Peri-implant pocket (Control group)
will be treated with non-surgical periodontal treatment only
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. The patient does not have any systemic disease
3. Patients with a probed pocket depth of 5-8 mm in at least one tooth in the opposite quadrant
4. According to the 2017 World Workshop on Classification of Periodontal and Peri-Implant Diseases and Conditions, patients of both sexes, aged 25-50 years, diagnosed with stage 2, grade B periodontitis
5. Patients with clinical loss of attachment of 3-4 mm, bleeding during probing and radiographic horizontal bone loss in the coronal third of the root (15-33%)
6. Clinical attachment loss of 3-4 mm in \<30% of teeth associated with periodontitis
7. Patients with a radiographic bone loss/age of 0.25-1 on the tooth with the greatest bone loss in the degree of periodontitis
8. Patients without anti-inflammatory drug use in the last 2 months
9. Patients who have not received antibiotic treatment in the last 6 months
Exclusion Criteria
2. To have undergone a surgical operation in the same region within the last 3 months
3. Smoking patients
4. Pregnancy
5. Presence of systemic conditions requiring antibiotic prophylaxis
6. Acute and untreated periodontitis
7. Patients receiving simultaneous treatment with a hyaluronic acid gel
18 Years
ALL
No
Sponsors
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Kutahya Health Sciences University
OTHER
Responsible Party
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Berceste Guler
Associate Professor Dr.
Principal Investigators
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Berceste Güler Ayyıldız, Assoc. Prof. Dr
Role: STUDY_DIRECTOR
Kütahya Health Sciences University
Locations
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Kütahya Health Sciences University Faculty of Dentistry
Kütahya, , Turkey (Türkiye)
Countries
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References
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Other Identifiers
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2023-15/01
Identifier Type: -
Identifier Source: org_study_id