Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06517030
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-03-06
Brief Title:
Socket Reconstruction Technique and Immediate Implant Placement With Two Different Bone Substitute Materials
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Clinical and Radiographic Evaluation of a Socket Reconstruction Technique and Immediate Implant Placement With Two Different Bone Substitute Materials a Multicentric Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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 present research is a national multicentric prospective parallel double-blinded both the patient and the examiner are blind randomized controlled clinical trial It is a superiority comparative study on a medical device CE conformité européenne marking used according to the intended use subject to the CE marking
The hypothesis tested is the socket reconstruction procedure performed in conjunction with Immediate implant placement IIP with the use of Deproteinized bovine bone mineral hyaluronic acid DBBMHA Cerabone plus leads to a greater increase in the vertical buccal bone height than same procedure with deproteinized bovine bone mineral alone DBBM Bio-oss Collagen
The hypothesis tested is the socket reconstruction procedure performed in conjunction with Immediate implant placement IIP with the use of Deproteinized bovine bone mineral hyaluronic acid DBBMHA Cerabone plus leads to a greater increase in the vertical buccal bone height than same procedure with deproteinized bovine bone mineral alone DBBM Bio-oss Collagen
Detailed Description:
The present research is a national multicentric prospective parallel double-blinded both the patient and the investigator who will perform the measurements are blind randomized controlled clinical trial It is a superiority comparative study on a medical device CE marking used according to the intended use subject to the CE marking
The hypothesis tested is the socket reconstruction procedure performed in conjunction with IIP with the use of DBBMHA leads to a greater increase in the vertical buccal bone height than same procedure with DBBM alone
The present study will be reported according to the CONSORT statement for improving the quality of reports of parallel-group randomized trials httpwwwconsort-statementorg
Patients will be randomly treated by means of IIPconnective tissue graft CTGDBBMHA Test group or A group or IIPCTGDBBM Control group or B group A randomization list will be generated in blocks patients will be divided in 3 blocks according to the study center MSan Raffaele Hospital Milan BUniversity of Bologna SUniversity of Siena and the treatment will be assigned at random in each block to ensure a balanced distribution of the tested interventions with a ratio testcontrol11 The investigator who will generate the allocation sequence will not be the person who will determine eligibility and entry of patients The assignments A or B group will enclose in serially numbered opaque sealed envelopes each bearing on the outside only the letter corresponding to the name of the center M B S and a number from 1 to 10 A designated investigator for each center will be responsible to ensure that the envelopes will be opened sequentially and only after the patient will undergo extraction of the hopeless tooth implant placement and clinical measurement assessment For each patient a sequential number will be assigned based on the date of enrollment and the envelope with the corresponding number will be opened for each of them
Both the investigator who will perform the measurements and the patients will be blinded to the randomization The principal investigator PI will make sure patients are blind by simply not telling them there is a difference between the two medical devices while he will ensure that investigator who will perform the measurements is blind by assigning a code or an identifying number to the two treatment groups so that they cannot know which device has been used
Patients will be followed for 6 months after surgery
The undermentioned 5 follow-up visits which are standard of practice for all implant-bearing patients will be scheduled for each patient for both treatment groups at
1 72 days post-surgery - clinical and photographic examination collection of VAS Visual Analogue Scale
2 144 days post-surgery - suture removal clinical and photographic examination
3 1 month7 days post-surgery - clinical and photographic examination
4 3 months5 days post-surgery - clinical and photographic examination measurements of the following parameters Gingival recession depth REC in mm Keratinized tissue width KTW in mm Soft tissue thickness GT in mm Pocket probing depth PPD in mm Bleeding on probing BoP Plaque index PI
5 6 months 1 month post-surgery - clinical and photographic examination CBCT scan periapical radiography 3D digital dental impression measurements of the following parameters Gingival recession depth REC in mm Keratinized tissue width KTW in mm Pocket probing depth PPD in mm Bleeding on probing BoP Plaque index PI
After the visit at 6 months each patient will then be considered off study eg subject has completed treatment and all follow-up visits
The hypothesis tested is the socket reconstruction procedure performed in conjunction with IIP with the use of DBBMHA leads to a greater increase in the vertical buccal bone height than same procedure with DBBM alone
The present study will be reported according to the CONSORT statement for improving the quality of reports of parallel-group randomized trials httpwwwconsort-statementorg
Patients will be randomly treated by means of IIPconnective tissue graft CTGDBBMHA Test group or A group or IIPCTGDBBM Control group or B group A randomization list will be generated in blocks patients will be divided in 3 blocks according to the study center MSan Raffaele Hospital Milan BUniversity of Bologna SUniversity of Siena and the treatment will be assigned at random in each block to ensure a balanced distribution of the tested interventions with a ratio testcontrol11 The investigator who will generate the allocation sequence will not be the person who will determine eligibility and entry of patients The assignments A or B group will enclose in serially numbered opaque sealed envelopes each bearing on the outside only the letter corresponding to the name of the center M B S and a number from 1 to 10 A designated investigator for each center will be responsible to ensure that the envelopes will be opened sequentially and only after the patient will undergo extraction of the hopeless tooth implant placement and clinical measurement assessment For each patient a sequential number will be assigned based on the date of enrollment and the envelope with the corresponding number will be opened for each of them
Both the investigator who will perform the measurements and the patients will be blinded to the randomization The principal investigator PI will make sure patients are blind by simply not telling them there is a difference between the two medical devices while he will ensure that investigator who will perform the measurements is blind by assigning a code or an identifying number to the two treatment groups so that they cannot know which device has been used
Patients will be followed for 6 months after surgery
The undermentioned 5 follow-up visits which are standard of practice for all implant-bearing patients will be scheduled for each patient for both treatment groups at
1 72 days post-surgery - clinical and photographic examination collection of VAS Visual Analogue Scale
2 144 days post-surgery - suture removal clinical and photographic examination
3 1 month7 days post-surgery - clinical and photographic examination
4 3 months5 days post-surgery - clinical and photographic examination measurements of the following parameters Gingival recession depth REC in mm Keratinized tissue width KTW in mm Soft tissue thickness GT in mm Pocket probing depth PPD in mm Bleeding on probing BoP Plaque index PI
5 6 months 1 month post-surgery - clinical and photographic examination CBCT scan periapical radiography 3D digital dental impression measurements of the following parameters Gingival recession depth REC in mm Keratinized tissue width KTW in mm Pocket probing depth PPD in mm Bleeding on probing BoP Plaque index PI
After the visit at 6 months each patient will then be considered off study eg subject has completed treatment and all follow-up visits
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