Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06618560
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-26
Brief Title:
Effect of Enamel Matrix Derivative or Hyaluronic Acid on Non-Surgical Treatment of Peri-Implantitis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Adjunctive Local Application of Enamel Matrix Derivative or Hyaluronic Acid to Non-surgical Mechanical Treatment of Peri-implantitis a 12-month Randomized Controlled Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of the present randomized controlled clinical study is to compare the clinical radiographic and patient-centered efficacy of adjunctive application of either enamel matrix derivative EMD or hyaluronic acid HA gel in conjunction with non-surgical therapy compared to non-surgical therapy alone following a 12-month healing period
Therefore the following question related to the study is raised
Does the adjunctive local application of EMD or HA to non-surgical submucosal mechanical treatment of peri-implantitis result in better clinical radiographic and patient-centered outcomes compared to non-surgical therapy alone
A total of 60 patients referred to the Gazi University Department of Periodontology will be randomly assigned to receive the local application of EMD or HA in combination with non-surgical submucosal mechanical treatment of peri-implantitis or non-surgical therapy alone Clinical measurements will be recorded at baseline 3 6 and 12 months after surgeries Patient oral health related to the treatment procedures using a written questionnaire Oral Health Impact Profile OHIP-14 and post-treatment pain and overall patient satisfaction about treatment modalities responses will be evaluated prior to treatment and 3 6 and 12 months following therapy
Therefore the following question related to the study is raised
Does the adjunctive local application of EMD or HA to non-surgical submucosal mechanical treatment of peri-implantitis result in better clinical radiographic and patient-centered outcomes compared to non-surgical therapy alone
A total of 60 patients referred to the Gazi University Department of Periodontology will be randomly assigned to receive the local application of EMD or HA in combination with non-surgical submucosal mechanical treatment of peri-implantitis or non-surgical therapy alone Clinical measurements will be recorded at baseline 3 6 and 12 months after surgeries Patient oral health related to the treatment procedures using a written questionnaire Oral Health Impact Profile OHIP-14 and post-treatment pain and overall patient satisfaction about treatment modalities responses will be evaluated prior to treatment and 3 6 and 12 months following therapy
Detailed Description:
Peri-implantitis is considered a growing public health problem in implant dentistry due to its higher prevalence and non-linear accelerating progression pattern Hence it is imperative to apply effective treatment strategies to manage this pathological condition The existing evidence has shown unpredictable therapeutic strategies for peri-implantitis Conventional non-surgical treatment procedures based on the removal of biofilm accumulation and debridementinstrumentation of the implant surface have exhibited limited disease resolution and persistent inflammation following therapy Therefore the application of adjunctive chemotherapeutic bioagents may provide greater disease resolution and reduce the need for surgical treatment
The application of EMD as an adjunctive measure in peri-implantitis treatment has been suggested to provide favorable outcomes by accelerating wound healing reducing inflammation having antimicrobial and antiseptic effects and osteopromotive features Although some studies exhibited clinical and radiographic efficacy of EMD in augmentative and non-augmentative surgical management of peri-implantitis there is no study in the available literature analyzing the effects of flapless application of EMD in non-surgical therapy of peri-implantitis Cross-linked HA which has recently been recognized as a featured adjuvant chemotherapeutic bioagent has also been shown to have beneficial effects in periodontal wound healing and soft and hard tissue regeneration The use of high-molecular-weight HA has been demonstrated to alter bacterial colonization in the advanced stage of peri-implantitis However there is limited evidence about the therapeutic effect of cross-linked HA in peri-implantitis management
The hypothesis of the study is that the application of EMD and cross-linked HA adjunct to non-surgical therapy could lead to superior outcomes compared to non-surgical therapy alone in peri-implantitis treatment The null-hypothesis H0 is that no statistically significant difference in terms of the mean change of probing depth PD values after 12 months would be detected among all the study groups
The aim of the present randomized controlled clinical study is to compare the clinical radiographic and patient-centered efficacy of adjunctive application of either enamel matrix derivative EMD or hyaluronic acid HA gel in conjunction with non-surgical therapy compared to non-surgical therapy alone following a 12-month healing period
The application of EMD as an adjunctive measure in peri-implantitis treatment has been suggested to provide favorable outcomes by accelerating wound healing reducing inflammation having antimicrobial and antiseptic effects and osteopromotive features Although some studies exhibited clinical and radiographic efficacy of EMD in augmentative and non-augmentative surgical management of peri-implantitis there is no study in the available literature analyzing the effects of flapless application of EMD in non-surgical therapy of peri-implantitis Cross-linked HA which has recently been recognized as a featured adjuvant chemotherapeutic bioagent has also been shown to have beneficial effects in periodontal wound healing and soft and hard tissue regeneration The use of high-molecular-weight HA has been demonstrated to alter bacterial colonization in the advanced stage of peri-implantitis However there is limited evidence about the therapeutic effect of cross-linked HA in peri-implantitis management
The hypothesis of the study is that the application of EMD and cross-linked HA adjunct to non-surgical therapy could lead to superior outcomes compared to non-surgical therapy alone in peri-implantitis treatment The null-hypothesis H0 is that no statistically significant difference in terms of the mean change of probing depth PD values after 12 months would be detected among all the study groups
The aim of the present randomized controlled clinical study is to compare the clinical radiographic and patient-centered efficacy of adjunctive application of either enamel matrix derivative EMD or hyaluronic acid HA gel in conjunction with non-surgical therapy compared to non-surgical therapy alone following a 12-month healing period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None