Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-26 @ 12:03 AM
Study NCT ID:
NCT05828394
Status:
COMPLETED
Last Update Posted:
2024-05-08
First Post:
2023-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Palate Wound Healing and Pain Perception of De-epthelized Ctg vs Sub-epithelial Ctg
Sponsor:
Universitat Internacional de Catalunya
Organization:
Study Overview
Official Title:
Palate Wound Healing and Pain Perception of De-epthelized Ctg vs Sub-epithelial Ctg
Status:
COMPLETED
Status Verified Date:
2024-05
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:
None
Brief Summary:
A single blinded randomized clinical trial was designed to evaluate the influence of palatal harvesting technique on post-operatory patient pain perception. The participants will be selected between subjects in need of at least one mucogingival procedure involving the harvesting of a connective tissue graft and then randomly allocated in the following groups. Two harvesting techniques were chosen to be compared: de-epithelialized free gingival graft (DFGG) and subepithelial connective tissue graft (SCTG).
Detailed Description:
To evaluate the postoperative pain, patients were instructed to complete a 100-mm VAS and classify the level of pain experienced on the palatal site from 0 to 10, with 10 being the worst pain ever experience. Analgesics intake (AI): Post-operative pain was indirectly evaluated on the basis of the mean mg consumption of analgesics (ibuprofene). Post operative complications (PC): To evaluate the excessive bleeding., patients were instructed to complete a 100-mm VAS and classify the level of bleeding experienced on the palatal site from 0 to 10. Dimensions of the needed graft (GD0): (x0=length, y0=height, z0=thickness) it will be measured once prepared the recipient site.
Dimensions of the harvested graft (GD1): (x1=length, y1=height, z1=thickness) it will be measured with a calliper calibrated in mm just after the harvesting. Surgical time (T): time required from harvesting the graft till the suture of the donor site. Intra surgical complications (IP): perforations of the palatal flap (in the case of the SCTG) and arterial bleeding will be registered and counted as intra-surgical complications. The following parameters will be calculated:
Palatal volume changes (V changes): Volumetric differences between the intraoral scans of baseline and at every following recall will be assessed with the aim of software (Geomagic by 3d systems). Superimposing the STL files using the teeth as fixed reference points will allow to measure differences in volume changes. Graft dimensions accuracy (GDA): It will be assessed comparing GD0, the needed dimensions of the graft (x0=length, y0= height, z0= thickness) with GD1, the actual dimensions of the harvested graft (x1=length, y1= height, z1= thickness). Mean baseline thickness of the palatal soft tissues (mT0): It will be measured superimposing the cbct with the intraoral scan at baseline. The measurements will be performed using a implant planning software. Mean final thickness of the palatal soft tissues (mT1): It will be measured superimposing the cbct with the intraoral scan at 12 weeks. The measurements will be performed using a implant planning.
Dimensions of the harvested graft (GD1): (x1=length, y1=height, z1=thickness) it will be measured with a calliper calibrated in mm just after the harvesting. Surgical time (T): time required from harvesting the graft till the suture of the donor site. Intra surgical complications (IP): perforations of the palatal flap (in the case of the SCTG) and arterial bleeding will be registered and counted as intra-surgical complications. The following parameters will be calculated:
Palatal volume changes (V changes): Volumetric differences between the intraoral scans of baseline and at every following recall will be assessed with the aim of software (Geomagic by 3d systems). Superimposing the STL files using the teeth as fixed reference points will allow to measure differences in volume changes. Graft dimensions accuracy (GDA): It will be assessed comparing GD0, the needed dimensions of the graft (x0=length, y0= height, z0= thickness) with GD1, the actual dimensions of the harvested graft (x1=length, y1= height, z1= thickness). Mean baseline thickness of the palatal soft tissues (mT0): It will be measured superimposing the cbct with the intraoral scan at baseline. The measurements will be performed using a implant planning software. Mean final thickness of the palatal soft tissues (mT1): It will be measured superimposing the cbct with the intraoral scan at 12 weeks. The measurements will be performed using a implant planning.
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?: