Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2025-12-26 @ 3:32 AM
Study NCT ID:
NCT04628520
Status:
UNKNOWN
Last Update Posted:
2020-11-13
First Post:
2020-10-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Surgical Protocol for Prevention of Mucositis
Sponsor:
Università Vita-Salute San Raffaele
Organization:
Study Overview
Official Title:
Effect of Soft Tissue Augmentation Procedures on Peri-implant Health
Status:
UNKNOWN
Status Verified Date:
2020-11
Last Known Status:
RECRUITING
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:
The main goal of implant therapy is to obtain long-term peri-implant health. Among local risk factors in the etiology of peri-implant diseases the absence of keratinized tissue (KT) around the implant has been reported. In fact, a certain amount of KT width, providing better sensory isolation and, hence, less pain discomfort during brushing, may be useful to facilitate plaque control. A good plaque control should maintain periimplant health during time.
A very recent systematic review assessed the effect of soft tissue grafting procedures on peri-implant health, revealing that soft tissue grafting using autogenous tissue for gain of KT results in a significant decrease of PI, BOP and GI values and significantly lower PI and GI values and higher marginal bone levels at the study endpoint compared to maintenance groups.
A very recent systematic review assessed the effect of soft tissue grafting procedures on peri-implant health, revealing that soft tissue grafting using autogenous tissue for gain of KT results in a significant decrease of PI, BOP and GI values and significantly lower PI and GI values and higher marginal bone levels at the study endpoint compared to maintenance groups.
Detailed Description:
Based in the available data in literature, it has been demonstrated that the level of brushing discomfort was significantly higher in sites with \<2 mm of KT width, which exhibited more plaque and more bleeding on probing than sites with ≥2 mm of KT width. Therefore, various procedures and materials were proposed in the past to augment the soft tissues around dental implant. Soft-tissue grafting seems beneficial, especially in posterior mandible, when patients complains of soreness during oral hygiene procedures and plaque control is less than ideal and it may be facilitated by a better topography. The surgical procedures most frequently used to increase the width of keratinized tissue around an implant-supported restoration include an apically positioned split-flap/vestibuloplasty (APF) with or without the application of autogenous tissue (i.e., free gingival graft) or a xenogeneic collagen matrix.
However, it remains unclear whether or not surgical procedures for gain of KT may establish peri-implant health limiting the incidence of peri-implant disease and may positively affect self-performed oral hygiene measures reducing peri-implant soft tissue inflammation when compared with non-augmented, inadequately dimensioned implant sites. Neither do clinical suggestions exist for a specific soft tissue transplant to obtain more favorable outcomes.
The aim of the present randomized controlled clinical trial is to assess the effect of soft tissue augmentation procedures at diseased (mucositis) implant sites in terms of:
* occurrence of peri-implant health (absence of BoP/suppuration, PPD\>6mm, longitudinal radiographic bone loss) at 3, 6 and 12 months
* reduction of BoP (%) at 3, 6 and 12 months
* marginal bone loss (MBL) at 12 months
* improvement of self-performed oral hygiene measures (PI, VAS) at 3, 6 and 12 months and post-operative morbidity (VAS) at 7 days.
* change in tissue morphology: increase of KT width (2D in mm.) and tissue volume (volumetric 3D) at 3, 6 and 12 months and aesthetic (blinder examiner) at 6, 12 months.
However, it remains unclear whether or not surgical procedures for gain of KT may establish peri-implant health limiting the incidence of peri-implant disease and may positively affect self-performed oral hygiene measures reducing peri-implant soft tissue inflammation when compared with non-augmented, inadequately dimensioned implant sites. Neither do clinical suggestions exist for a specific soft tissue transplant to obtain more favorable outcomes.
The aim of the present randomized controlled clinical trial is to assess the effect of soft tissue augmentation procedures at diseased (mucositis) implant sites in terms of:
* occurrence of peri-implant health (absence of BoP/suppuration, PPD\>6mm, longitudinal radiographic bone loss) at 3, 6 and 12 months
* reduction of BoP (%) at 3, 6 and 12 months
* marginal bone loss (MBL) at 12 months
* improvement of self-performed oral hygiene measures (PI, VAS) at 3, 6 and 12 months and post-operative morbidity (VAS) at 7 days.
* change in tissue morphology: increase of KT width (2D in mm.) and tissue volume (volumetric 3D) at 3, 6 and 12 months and aesthetic (blinder examiner) at 6, 12 months.
Study Oversight
Has Oversight DMC:
True
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?: