Ignite Creation Date:
2024-05-06 @ 11:06 AM
Last Modification Date:
2024-10-26 @ 12:40 PM
Study NCT ID:
NCT03431766
Status:
UNKNOWN
Last Update Posted:
2018-02-13
First Post:
2018-01-15
Brief Title:
02 Chx Gel vs Implant Bacterial Contamination
Sponsor:
G dAnnunzio University
Organization:
G dAnnunzio University
Study Overview
Official Title:
A Prospective Randomized-controlled Study of the Effect of a Chlorhexidine Based Gel on the Internal Implant Surface Treatment on the Reduction of Bacterial Load and on the Regressive Bone Modelling
Status:
UNKNOWN
Status Verified Date:
2018-02
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 objective of this human randomized double blind placebo-control RDBPC study is to evaluate the efficacy of a 02 chlorhexidine CHX gel on reducing bacterial load and peri-implant inflammation at implant-abutment interface during the early healing stageThirty-six healthy patients mean age 5228 years range 29-75 years without a significant past medical anamnesis all non-smokers will be recruited as candidates for single implant placement and prosthetic rehabilitationPatients will be randomly divided in group A control and group B test as indicated by the randomization chart All Implants Cortex classic Shalomi Israelwould be inserted by two skilled operators who followed a two-stage protocol and placed them according to the manufacturers instructionsEventually all patients will be rehabilitated with a single implant-supported crown During all the stages either a gel containing 020 CHX Plak Gel Polifarma Wellness Srl Rome Italy or a placebo gel Placebo Polifarma Wellness Srl Rome Italy will be used The two gels are perfectly alike in packaging color and smell and nobody knew the exact location of placebo or test gel which will be revealed only after data collection would be performed by the person who prepared them A or B gel will be placed on the internal connection abutments and then a cover screw would be inserted Finally the site would be sutured with non-absorbable nylon sutures Cone Beam Computed Tomography evaluation CBCT VatechIpax 3D PCH-6500 Fort Lee NJ USA would be performed both for pre-operative and post-surgical implant placement Both gels will be given to the patients according to the protocol and applied 2 timesday until suture removal after 7 days Soft tissue biopsies would be performed by means of a circular scalpel 55 mm in diameter at the implant insertion T0 and after two months of healing second stage surgeryT1 to analyze the peri-implant inflammatory infiltrate and the micro-vessel density MVD in both groups All the radiographs taken during the study time points would be analysed to measure the bone resorption after 1 year or on other studt time points
Detailed Description:
The objective of this human randomized double blind placebo-control RDBPC study is to evaluate the efficacy of a 02 chlorhexidine CHX gel on reducing bacterial load and peri-implant inflammation at implant-abutment interface during the early healing stage Thirty-six healthy patients mean age 5228 years range 29-75 years without a significant past medical anamnesis all non-smokers will be recruited as candidates for single implant placement and prosthetic rehabilitationPatients will be randomly divided in group A control and group B test as indicated by the randomization chart The randomization of this prospective randomized-controlled double blind study was obtained using computer generated random numbers centralized with sequentially sealed opaque envelopes provided by the study adviserThe surgeon will open the sealed envelope containing the randomized group only after having inserted the implantDuring the first evaluation all subjects will be clinically examined radiographs plaque and bleeding scores would be carried out for diagnostic evaluation then the patients would be scheduled for surgery procedures All Implants Cortex classic Shalomi Israel would be inserted by two skilled operators who will follow a two-stage protocol and would place them according to the manufacturers instructions Before surgery all the patients would be subject to applications of chlorhexidine digluconate solution 02 for 2 minutes to obtain lower bacterial load and local anesthesia would be given with Articaine Ubistesin 4 - Espe Dental AG Seefeld Germany associated with epinephrine 1100000 Eventually all patients would be rehabilitated with a single implant-supported crown During all the stages either a gel containing 020 CHX Plak Gel Polifarma Wellness Srl Rome Italy or a placebo gel Placebo Polifarma Wellness Srl Rome Italy would be used The two gels are perfectly alike in packaging colour and smell and nobody knows the exact location of placebo or test gel which would be revealed only after data collection would be performed by the person who prepared them A or B gel would be placed on the internal connection abutments and then a cover screw would be inserted Finally the site would be sutured with non-absorbable nylon sutures Cone Beam Computed Tomography evaluation CBCT VatechIpax 3D PCH-6500 Fort Lee NJ USA would be performed both for pre-operative and post-surgical implant placement All patients will recieve antibiotic therapy 2gday for 6 days Augumentin Glaxo-Smithkline Beecham Brentford UKThe post-operative pain would be controlled with NSAIDs and oral hygiene instructions would be given Both gels would be given to the patients according to the protocol and applied 2 timesday until suture removal after 7 days Soft tissue biopsies would be performed by means of a circular scalpel 55 mm in diameter at the implant insertion T0 and after two months of healing second stage surgeryT1 to analyze the peri-implant inflammatory infiltrate and the micro-vessel density MVD in both groups
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