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

NCT06740123 | Active Not Recruiting

• 1 other identifier: 2023-15/01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Periodontitis; Peri-implantitis; Hydrogel; non-surgical periodontal treatment

Outcome Measures

Primary Outcomes (3)

• Periodontal or peri-implant pocket depth

  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.

  3-month follow-up of all implants and teeth

• Proinflammatory markers

  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.

  3-month follow-up of all implants and teeth

• Marginal bone level change

  The primary outcome was measurement of marginal bone level on periapical radiographs and cone-beam computed tomography at 6-month follow-up.

  6-month follow-up of all implants and teeth

Secondary Outcomes (1)

• Patients participating in the evaluation of a treatment may encounter both adverse and beneficial events associated with that treatment

  6-month follow-up of all implants and teeth

Study Arms (4)

Periodontal pocket (Test group)

EXPERIMENTAL

To be treated with non-surgical periodontal treatment and intra-pocket H42 hydrogel application.

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

Periodontal pocket (Control group)

EXPERIMENTAL

To be treated with non-surgical periodontal treatment only

Procedure: Nonsurgical periodontal treatment of periodontal pocket

Peri-implant pocket (Test group)

EXPERIMENTAL

Will be treated with non-surgical periodontal treatment and intra-pocket H42 hydrogel application.

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

Peri-implant pocket (Control group)

EXPERIMENTAL

will be treated with non-surgical periodontal treatment only

Procedure: Nonsurgical periodontal treatment of peri-implant pocket

Interventions

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

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 (Test group)

Nonsurgical periodontal treatment of periodontal pocket PROCEDURE

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.

Periodontal pocket (Control group)

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

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 (Test group)

Nonsurgical periodontal treatment of peri-implant pocket PROCEDURE

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.

Peri-implant pocket (Control group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• be over 18 years old
• The patient does not have any systemic disease
• Patients with a probed pocket depth of 5-8 mm in at least one tooth in the opposite quadrant
• 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
• 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%)
• Clinical attachment loss of 3-4 mm in \<30% of teeth associated with periodontitis
• Patients with a radiographic bone loss/age of 0.25-1 on the tooth with the greatest bone loss in the degree of periodontitis
• Patients without anti-inflammatory drug use in the last 2 months
• Patients who have not received antibiotic treatment in the last 6 months

You may not qualify if:

• Any systemic disease that may adversely affect the results of treatment (receiving radiotherapy and chemotherapy, systemic bisphosphonate, and corticosteroid use) to be found
• To have undergone a surgical operation in the same region within the last 3 months
• Smoking patients
• Pregnancy
• Presence of systemic conditions requiring antibiotic prophylaxis
• Acute and untreated periodontitis
• Patients receiving simultaneous treatment with a hyaluronic acid gel

Sponsors & Collaborators

• Kutahya Health Sciences University: lead

Study Sites (1)

Kütahya Health Sciences University Faculty of Dentistry

Kütahya, 43100, Turkey (Türkiye)

Location

Related Publications (35)

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MeSH Terms

Conditions

Periodontal Diseases; Peri-Implantitis; Periodontitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Berceste Güler Ayyıldız, Assoc. Prof. Dr

  Kütahya Health Sciences University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Dr.

Model Details: 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. Patients with periodontal/peri-implant pockets will be evaluated in a total of four groups after non-surgical periodontal treatment, two different groups, one side of the patients will be the test group and the other side will be the control group. All patients will be randomly allocated to the study groups using the sealed envelope method.

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: December 18, 2024
• Study Start: June 1, 2024
• Primary Completion: January 1, 2026
• Study Completion: March 1, 2026
• Last Updated: December 18, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The work will be shared 6 months after publication.
• Access Criteria: It will be shared in case the principal investigator is contacted.

Locations

TU (1)