Evaluation of Hydrogel Application in the Treatment of Periodontitis and Peri-implantitis (NCT06740123) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Evaluation of Hydrogel Application in the Treatment of Periodontitis and Peri-implantitis
Turkey (Türkiye)30 participantsStarted 2024-06-01
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Periodontal or peri-implant pocket depth
Timeframe: 3-month follow-up of all implants and teeth
2
Proinflammatory markers
Timeframe: 3-month follow-up of all implants and teeth
3
Marginal bone level change
Timeframe: 6-month follow-up of all implants and teeth
. Patients without anti-inflammatory drug use in the last 2 months
Exclusion criteria
. 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