Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06455306
Status:
RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-05-18
Brief Title:
Erythritol Air Polishing in Mucositis Treatment
Sponsor:
University of Coimbra
Organization:
University of Coimbra
Study Overview
Official Title:
Erythritol Air Polishing in Mucositis Treatment A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aimed to evaluate the effectiveness of air polishing systems compared to the exclusive use of oral hygiene instruction in the treatment of peri-implant mucositis
Detailed Description:
The study will include individuals aged 18 to 80 who have at least one implant and exhibit peri-implant mucositis as defined by the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions
Participants will be selected from those attending Periodontology Oral Surgery and Oral Medicine consultations at the dental medicine clinic of the University Hospital Center of the University of Coimbra CHUC After confirming the inclusion and exclusion criteria patients will be invited to participate in the study and if they agree to participate they will sign an Informed Consent Form
The study is conducted as a parallel-design clinical trial and each participant will be randomly allocated to one of three groups Test 1 T1 Test 2 T2 or Control C
Group T1 will consist of patients receiving a single application of treatment with an air-polishing device with erythritol in addition to oral hygiene instructions OHI Group T2 will consist of patients receiving monthly applications months 0 1 and 2 of treatment with an air-polishing device with erythritol along with OHI Group C will consist of patients receiving only OHI The treatments and OHI will be performed by an experienced periodontist who is different from the one collecting clinical radiographic and PICF data
The clinical examination that will be performed at baseline 3 and 6 months after baseline includes a periodontal chart at six sites per each tooth andor included implant
In addition collection of peri-implant crevicular fluid PICF will be done to evaluate a panel of biomarkers Samples will be collected from two locations around each implant isolated with cotton rolls and dried Using the filter paper technique a strip of standard length and height filter paper Periopaper Pro Flow New York USA will be inserted into the peri-implant sulcus and left in place for 30 seconds Samples will be placed in plastic centrifuge tubes and kept on ice until they are frozen -80C in the laboratory of the Clinical Pathology Service at CHUC Sampling should be performed prior to peri-implant clinical examination and after gentle removal of supra-gingival plaque Biochemical analysis will be conducted using Luminex to evaluate the inflammatory pattern through the use of a panel of biomarkers
Schedule of appointments by Group
Group T1 Month 0 appointment collection of clinical data X-rays and Peri-implant crevicular fluid PICF OHI treatment Month 3 appointment collection of clinical data and PICF Month 6 appointment collection of clinical data X-rays and PICF
Group T2 Month 0 appointment collection of clinical data X-rays and PICF OHI treatment Month 1 appointment OHI treatment Month 2 appointment OHI treatment Month 3 appointment collection of clinical data and PICF Month 6 appointment collection of clinical data X-rays and PICF
Group C Month 0 appointment collection of clinical data X-rays and PICF OHI Month 3 appointment collection of clinical data and PICF Month 6 appointment collection of clinical data X-rays and PICF
Participants will be selected from those attending Periodontology Oral Surgery and Oral Medicine consultations at the dental medicine clinic of the University Hospital Center of the University of Coimbra CHUC After confirming the inclusion and exclusion criteria patients will be invited to participate in the study and if they agree to participate they will sign an Informed Consent Form
The study is conducted as a parallel-design clinical trial and each participant will be randomly allocated to one of three groups Test 1 T1 Test 2 T2 or Control C
Group T1 will consist of patients receiving a single application of treatment with an air-polishing device with erythritol in addition to oral hygiene instructions OHI Group T2 will consist of patients receiving monthly applications months 0 1 and 2 of treatment with an air-polishing device with erythritol along with OHI Group C will consist of patients receiving only OHI The treatments and OHI will be performed by an experienced periodontist who is different from the one collecting clinical radiographic and PICF data
The clinical examination that will be performed at baseline 3 and 6 months after baseline includes a periodontal chart at six sites per each tooth andor included implant
In addition collection of peri-implant crevicular fluid PICF will be done to evaluate a panel of biomarkers Samples will be collected from two locations around each implant isolated with cotton rolls and dried Using the filter paper technique a strip of standard length and height filter paper Periopaper Pro Flow New York USA will be inserted into the peri-implant sulcus and left in place for 30 seconds Samples will be placed in plastic centrifuge tubes and kept on ice until they are frozen -80C in the laboratory of the Clinical Pathology Service at CHUC Sampling should be performed prior to peri-implant clinical examination and after gentle removal of supra-gingival plaque Biochemical analysis will be conducted using Luminex to evaluate the inflammatory pattern through the use of a panel of biomarkers
Schedule of appointments by Group
Group T1 Month 0 appointment collection of clinical data X-rays and Peri-implant crevicular fluid PICF OHI treatment Month 3 appointment collection of clinical data and PICF Month 6 appointment collection of clinical data X-rays and PICF
Group T2 Month 0 appointment collection of clinical data X-rays and PICF OHI treatment Month 1 appointment OHI treatment Month 2 appointment OHI treatment Month 3 appointment collection of clinical data and PICF Month 6 appointment collection of clinical data X-rays and PICF
Group C Month 0 appointment collection of clinical data X-rays and PICF OHI Month 3 appointment collection of clinical data and PICF Month 6 appointment collection of clinical data X-rays and PICF
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None