Periodontal Disease Stage 2NCT06740123
Evaluation of Hydrogel Application in the Treatment of Periodontitis and Peri-implantitis
A study testing Nonsurgical periodontal treatment and application of H42® hydrogel to the peri-implant pocket, Nonsurgical periodontal treatment of periodontal pocket and Non-surgical periodontal treatment and application of H42® hydrogel to the periodontal pocket in people with Periodontal Disease Stage 2 and Peri-Implantitis and Peri-implant Mucositis, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontal Disease Stage 2, Peri-Implantitis and Peri-implant Mucositis, Periodontal Regeneration
- What is being tested?
- Nonsurgical periodontal treatment and application of H42® hydrogel to the peri-implant pocket, Nonsurgical periodontal treatment of periodontal pocket and Non-surgical periodontal treatment and application of H42® hydrogel to the periodontal pocket
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2024to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kütahya Health Sciences University Faculty of Dentistry
Kütahya, 43100
About this study
Official title: Clinical, Radiological, and Biochemical Evaluation of Adjunctive Hydrogel Application in the Non-Surgical Treatment of Peri-implantitis and Periodontitis
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
Read the detailed description
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.
- Conditions
- Periodontal Disease Stage 2, Peri-Implantitis and Peri-implant Mucositis, Periodontal Regeneration
- Being tested
- Nonsurgical periodontal treatment and application of H42® hydrogel to the peri-implant pocket, Nonsurgical periodontal treatment of periodontal pocket, Non-surgical periodontal treatment and application of H42® hydrogel to the periodontal pocket, Nonsurgical periodontal treatment of peri-implant pocket
- Keywords
- Periodontitis, Peri-implantitis, Hydrogel, non-surgical periodontal treatment
- Medical subject headings
- Periodontal Diseases, Peri-Implantitis, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nonsurgical periodontal treatment and application of H42® hydrogel to the peri-implant pocketProcedure or surgery
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 pocketProcedure or surgery
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 pocketProcedure or surgery
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 pocketProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Periodontal pocket (Test group) | Experimental | To be treated with non-surgical periodontal treatment and intra-pocket H42 hydrogel application. Receives: 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 Receives: 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. Receives: 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 Receives: Procedure: Nonsurgical periodontal treatment of peri-implant pocket |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Both adverse and beneficial events associated with the evaluated treatment will be systematically documented for each patient at 6 months. The change in patients' pain scores on the Numerical Rating Scale from baseline to 3 months after treatment will be measured.
Measured: 6-month follow-up of all implants and teeth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start1 Jun 2024
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)Papers the sponsor has linked to this study.
- Other trials for Periodontal Disease Stage 2Studies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berceste Guler, Kutahya Health Sciences University
- Investigators
- Berceste Güler Ayyıldız, Assoc. Prof. Dr, Study director, Kütahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06740123
- Sponsor's protocol ID
- 2023-15/01
- Status last verified
- Nov 2024
- First submitted
- 27 Nov 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol Statistical Analysis Plan (SAP)
Publications
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.
PubMed 34603290Zhou 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.
PubMed 20817183Zhou S, Miao D, Wen J, Zhang Q, Hu D, Liu N, Li J, Zhang Y, Wang K, Chen Y. Microcin C7-laden modified gelatin based biocomposite hydrogel for the treatment of periodontitis. Int J Biol Macromol. 2024 Feb;258(Pt 1):128293. doi: 10.1016/j.ijbiomac.2023.128293. Epub 2023 Nov 22.
PubMed 38000587Santos MS, Dos Santos AB, Carvalho MS. New Insights in Hydrogels for Periodontal Regeneration. J Funct Biomater. 2023 Nov 11;14(11):545. doi: 10.3390/jfb14110545.
PubMed 37998114Ivanov AA, Kuznetsova AV, Popova OP, Danilova TI, Latyshev AV, Yanushevich OO. Influence of Extracellular Matrix Components on the Differentiation of Periodontal Ligament Stem Cells in Collagen I Hydrogel. Cells. 2023 Sep 22;12(19):2335. doi: 10.3390/cells12192335.
PubMed 37830549Linares A, Sanz-Sanchez I, Dopico J, Molina A, Blanco J, Montero E. Efficacy of adjunctive measures in the non-surgical treatment of peri-implantitis: A systematic review. J Clin Periodontol. 2023 Jun;50 Suppl 26:224-243. doi: 10.1111/jcpe.13821. Epub 2023 May 4.
PubMed 37143407Ambili R, Nazimudeen NB. Adjunctive benefit of probiotic supplementation along with nonsurgical therapy for peri-implant diseases - A systematic review and meta-analysis. J Indian Soc Periodontol. 2023 Jul-Aug;27(4):352-361. doi: 10.4103/jisp.jisp_308_22. Epub 2023 Jul 1.
PubMed 37593565Altindal D, Alkan EA, Calisir M. Evaluation of the effectiveness of diode laser therapy in conjunction with nonsurgical treatment of peri-implantitis. J Periodontal Implant Sci. 2023 Oct;53(5):376-387. doi: 10.5051/jpis.2203140157. Epub 2023 Feb 3.
PubMed 37038829Mombelli A, Feloutzis A, Bragger U, Lang NP. Treatment of peri-implantitis by local delivery of tetracycline. Clinical, microbiological and radiological results. Clin Oral Implants Res. 2001 Aug;12(4):287-94. doi: 10.1034/j.1600-0501.2001.012004287.x. English, French, German.
PubMed 11488856Linares A, Pico A, Blanco C, Blanco J. Adjunctive Systemic Metronidazole to Nonsurgical Therapy of Peri-implantitis with Intrabony Defects: A Retrospective Case Series Study. Int J Oral Maxillofac Implants. 2019 Sep/Oct;34(5):1237-1245. doi: 10.11607/jomi.7343.
PubMed 31528867Estefania-Fresco R, Garcia-de-la-Fuente AM, Egana-Fernandez-Valderrama A, Bravo M, Aguirre-Zorzano LA. One-year results of a nonsurgical treatment protocol for peri-implantitis. A retrospective case series. Clin Oral Implants Res. 2019 Jul;30(7):702-712. doi: 10.1111/clr.13456. Epub 2019 Jun 1.
PubMed 31090974Daubert D, Lee E, Botto A, Eftekhar M, Palaiologou A, Kotsakis GA. Assessment of titanium release following non-surgical peri-implantitis treatment: A randomized clinical trial. J Periodontol. 2023 Sep;94(9):1122-1132. doi: 10.1002/JPER.22-0716. Epub 2023 May 2.
PubMed 37070363Schwarz F, Ramanauskaite A. It is all about peri-implant tissue health. Periodontol 2000. 2022 Feb;88(1):9-12. doi: 10.1111/prd.12407.
PubMed 35103327Renvert S, Polyzois I, Persson GR. Treatment modalities for peri-implant mucositis and peri-implantitis. Am J Dent. 2013 Dec;26(6):313-8.
PubMed 24640434Figuero E, Graziani F, Sanz I, Herrera D, Sanz M. Management of peri-implant mucositis and peri-implantitis. Periodontol 2000. 2014 Oct;66(1):255-73. doi: 10.1111/prd.12049.
PubMed 25123773
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Radiological, and Biochemical Evaluation of Adjunctive Hydrogel Application in the Non-Surgical Treatment of Peri-implantitis and Periodontitis
- ClinicalTrials.gov ID
- NCT06740123
- Acronym / sponsor ID
- 2023-15/01
- Conditions
- Periodontal Disease Stage 2, Peri-Implantitis and Peri-implant Mucositis, Periodontal Regeneration
- Keywords
- Periodontitis, Peri-implantitis, Hydrogel, non-surgical periodontal treatment
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 18 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Periodontal pocket (Test group) | Experimental | Procedure: Non-surgical periodontal treatment and application of H42® hydrogel to the periodontal pocketTo be treated with non-surgical periodontal treatment and intra-pocket H42 hydrogel application. |
| Periodontal pocket (Control group) | Experimental | Procedure: Nonsurgical periodontal treatment of periodontal pocketTo be treated with non-surgical periodontal treatment only |
| Peri-implant pocket (Test group) | Experimental | Procedure: Nonsurgical periodontal treatment and application of H42® hydrogel to the peri-implant pocketWill be treated with non-surgical periodontal treatment and intra-pocket H42 hydrogel application. |
| Peri-implant pocket (Control group) | Experimental | Procedure: Nonsurgical periodontal treatment of peri-implant pocketwill be treated with non-surgical periodontal treatment only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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%)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nonsurgical periodontal treatment and application of H42® hydrogel to the peri-implant pocketFirstly, 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. | Procedure or surgery | Peri-implant pocket (Test group) |
| Nonsurgical periodontal treatment of periodontal pocketSystemic 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. | Procedure or surgery | Periodontal pocket (Control group) |
| Non-surgical periodontal treatment and application of H42® hydrogel to the periodontal pocketFirstly, 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. | Procedure or surgery | Periodontal pocket (Test group) |
| Nonsurgical periodontal treatment of peri-implant pocketSystemic 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. | Procedure or surgery | Peri-implant pocket (Control group) |
Primary outcome
Periodontal or peri-implant pocket depth
Time frame: 3-month follow-up of all implants and teeth
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.
Proinflammatory markers
Time frame: 3-month follow-up of all implants and teeth
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.
Marginal bone level change
Time frame: 6-month follow-up of all implants and teeth
The primary outcome was measurement of marginal bone level on periapical radiographs and cone-beam computed tomography at 6-month follow-up.
1 secondary outcome
Patients participating in the evaluation of a treatment may encounter both adverse and beneficial events associated with that treatment
Time frame: 6-month follow-up of all implants and teeth
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Results publication: PubMed 34603290Kanjevac 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.
- Results publication: PubMed 20817183Zhou 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.
- Results publication: PubMed 38000587Zhou S, Miao D, Wen J, Zhang Q, Hu D, Liu N, Li J, Zhang Y, Wang K, Chen Y. Microcin C7-laden modified gelatin based biocomposite hydrogel for the treatment of periodontitis. Int J Biol Macromol. 2024 Feb;258(Pt 1):128293. doi: 10.1016/j.ijbiomac.2023.128293. Epub 2023 Nov 22.
- Results publication: PubMed 37998114Santos MS, Dos Santos AB, Carvalho MS. New Insights in Hydrogels for Periodontal Regeneration. J Funct Biomater. 2023 Nov 11;14(11):545. doi: 10.3390/jfb14110545.
- Results publication: PubMed 37830549Ivanov AA, Kuznetsova AV, Popova OP, Danilova TI, Latyshev AV, Yanushevich OO. Influence of Extracellular Matrix Components on the Differentiation of Periodontal Ligament Stem Cells in Collagen I Hydrogel. Cells. 2023 Sep 22;12(19):2335. doi: 10.3390/cells12192335.
- Results publication: PubMed 37143407Linares A, Sanz-Sanchez I, Dopico J, Molina A, Blanco J, Montero E. Efficacy of adjunctive measures in the non-surgical treatment of peri-implantitis: A systematic review. J Clin Periodontol. 2023 Jun;50 Suppl 26:224-243. doi: 10.1111/jcpe.13821. Epub 2023 May 4.
- Results publication: PubMed 37593565Ambili R, Nazimudeen NB. Adjunctive benefit of probiotic supplementation along with nonsurgical therapy for peri-implant diseases - A systematic review and meta-analysis. J Indian Soc Periodontol. 2023 Jul-Aug;27(4):352-361. doi: 10.4103/jisp.jisp_308_22. Epub 2023 Jul 1.
- Results publication: PubMed 37038829Altindal D, Alkan EA, Calisir M. Evaluation of the effectiveness of diode laser therapy in conjunction with nonsurgical treatment of peri-implantitis. J Periodontal Implant Sci. 2023 Oct;53(5):376-387. doi: 10.5051/jpis.2203140157. Epub 2023 Feb 3.
- Results publication: PubMed 11488856Mombelli A, Feloutzis A, Bragger U, Lang NP. Treatment of peri-implantitis by local delivery of tetracycline. Clinical, microbiological and radiological results. Clin Oral Implants Res. 2001 Aug;12(4):287-94. doi: 10.1034/j.1600-0501.2001.012004287.x. English, French, German.
- Results publication: PubMed 31528867Linares A, Pico A, Blanco C, Blanco J. Adjunctive Systemic Metronidazole to Nonsurgical Therapy of Peri-implantitis with Intrabony Defects: A Retrospective Case Series Study. Int J Oral Maxillofac Implants. 2019 Sep/Oct;34(5):1237-1245. doi: 10.11607/jomi.7343.
- Results publication: PubMed 31090974Estefania-Fresco R, Garcia-de-la-Fuente AM, Egana-Fernandez-Valderrama A, Bravo M, Aguirre-Zorzano LA. One-year results of a nonsurgical treatment protocol for peri-implantitis. A retrospective case series. Clin Oral Implants Res. 2019 Jul;30(7):702-712. doi: 10.1111/clr.13456. Epub 2019 Jun 1.
- Results publication: PubMed 37070363Daubert D, Lee E, Botto A, Eftekhar M, Palaiologou A, Kotsakis GA. Assessment of titanium release following non-surgical peri-implantitis treatment: A randomized clinical trial. J Periodontol. 2023 Sep;94(9):1122-1132. doi: 10.1002/JPER.22-0716. Epub 2023 May 2.
- Individual participant dataSharing planned: Yes. Study Protocol Statistical Analysis Plan (SAP)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Berceste Güler Ayyıldız, Assoc. Prof. Dr study director
Kütahya Health Sciences University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nonsurgical periodontal treatment and application of H42® hydrogel to the peri-implant pocket, Nonsurgical periodontal treatment of periodontal pocket and Non-surgical periodontal treatment and application of H42® hydrogel to the periodontal pocket in people with Periodontal Disease Stage 2 and Peri-Implantitis and Peri-implant Mucositis, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Periodontal or peri-implant pocket depth (time frame: 3-month follow-up of all implants and teeth). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06740123, which also lists 35 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.