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Clinical, Radiological, and Biochemical Evaluation of Adjunctive Hydrogel Application in the Non-Surgical Treatment of Peri-implantitis and Periodontitis
Sponsor study identifier
interventional
30
1 country
1
Study Start
June 1, 2024
Actual (reported)Primary Completion
January 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 1, 2024
Actual (reported)November 27, 2024
Actual (reported)December 18, 2024
Actual (reported)January 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
To be treated with non-surgical periodontal treatment and intra-pocket H42 hydrogel application.
To be treated with non-surgical periodontal treatment only
Will be treated with non-surgical periodontal treatment and intra-pocket H42 hydrogel application.
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.
Kütahya Health Sciences University Faculty of Dentistry
Kütahya, 43100, Turkey (Türkiye)
Kanjevac T, Taso E, Stefanovic V, Petkovic-Curcin A, Supic G, Markovic D, Djukic M, Djuran B, Vojvodic D, Sculean A, Rakic M. Estimating the Effects of Dental Caries and Its Restorative Treatment on Periodontal Inflammatory and Oxidative Status: A Short Controlled Longitudinal Study. Front Immunol. 2021 Sep 15;12:716359. doi: 10.3389/fimmu.2021.716359. eCollection 2021.
Zhou Y, Petpichetchian W, Kitrungrote L. Psychometric properties of pain intensity scales comparing among postoperative adult patients, elderly patients without and with mild cognitive impairment in China. Int J Nurs Stud. 2011 Apr;48(4):449-57. doi: 10.1016/j.ijnurstu.2010.08.002.
Berceste Güler Ayyıldız, Assoc. Prof. Dr
Kütahya Health Sciences University
First Submitted
November 27, 2024
First Posted
December 18, 2024
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
will be treated with non-surgical periodontal treatment only
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.
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Study Start
June 1, 2024
Actual (reported)Primary Completion
January 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
December 18, 2024
Record last verified: 2024-11
Study Protocol Statistical Analysis Plan (SAP)
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