Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04782921
Status:
COMPLETED
Last Update Posted:
2023-01-25
First Post:
2021-03-01
Brief Title:
Papillae Tunneling Techniques in the Treatment of Isolated Intrabony Defects
Sponsor:
University of Ljubljana
Organization:
University of Ljubljana
Study Overview
Official Title:
Clinical Outcomes of Papillae Tunneling Techniques in the Treatment of Isolated Intrabony Defects - a Prospective Double Blind Randomised Clinical Trial
Status:
COMPLETED
Status Verified Date:
2022-01
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:
PTT
Brief Summary:
Papillae tunneling techniques PTT are a new approach toward regeneration of isolated intrabony defects Compared to regular papillae preservation techniques PTT rely on complete preservation of involved interdental papillae providing optimal healing environment for periodontal wound Surgical access is therefore gained either by vertical incision in vestibulum or by short releasing incision on adjacent tooth Interdental tissue is then carefully raised in a full thickness manner by tunneling instruments root surface thoroughly cleaned by the ultrasound scaler or Gracey curettes and defect filled with the biomaterial of choice
While the success and aesthetic results of non-incised papillae techniques are well documented no paper so far compared clinical results of papillae preservation techniques with different biomaterials
Therefore the aim of our study is to compare gain of clinical attachment level defined by sum of pocket probing depth and recession to regular papillae preservation techniques and to prove non-inferiority of Gel 40 collagen matrix loaded with micronized heterologous bone to Gen-Os granulated cortico-cancellous heterologous bone mix
Secondary objectives include analysis of aesthetic parameters - differences in recession and tip of the papillae location before and after the treatment
While the success and aesthetic results of non-incised papillae techniques are well documented no paper so far compared clinical results of papillae preservation techniques with different biomaterials
Therefore the aim of our study is to compare gain of clinical attachment level defined by sum of pocket probing depth and recession to regular papillae preservation techniques and to prove non-inferiority of Gel 40 collagen matrix loaded with micronized heterologous bone to Gen-Os granulated cortico-cancellous heterologous bone mix
Secondary objectives include analysis of aesthetic parameters - differences in recession and tip of the papillae location before and after the treatment
Detailed Description:
None
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