Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06250179
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-08
First Post:
2024-02-01
Brief Title:
3D VOLUMETRIC CHANGE OF THE PALATAL DONOR REGION IN WOUND HEALING
Sponsor:
Necmettin Erbakan University
Organization:
Necmettin Erbakan University
Study Overview
Official Title:
3D VOLUMETRIC CHANGE OF THE PALATAL DONOR REGION IN WOUND HEALING
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
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:
DIMENSIONAL
Brief Summary:
The purpose of this clinical trial is planned to be conducted with 45 individuals aged between 18-65 with Cairo type I gingival recession and patients requiring free gingival surgery It was aimed to investigate when the palatal mucosa will return to its previous volume in the donor area and the effect of smoking The main questions it aims to answer are
Evaluation of 3D volume change of the palatal donor area from which free gingival graft was taken
determining how long it takes for the palatal mucosa to regain its original shape and thickness Participants will be asked to comply with postoperative recommendations and pay attention to oral hygiene
If there is a comparison group Researchers use it to see if smoking affects the volume change in the donor area
They will compare non-smokers with clinically healthy gums light smokers who report smoking less than 5 cigarettes per day and patients with clinically healthy gums and ex-smokers with clinically healthy gums who have not smoked for 5 years
Evaluation of 3D volume change of the palatal donor area from which free gingival graft was taken
determining how long it takes for the palatal mucosa to regain its original shape and thickness Participants will be asked to comply with postoperative recommendations and pay attention to oral hygiene
If there is a comparison group Researchers use it to see if smoking affects the volume change in the donor area
They will compare non-smokers with clinically healthy gums light smokers who report smoking less than 5 cigarettes per day and patients with clinically healthy gums and ex-smokers with clinically healthy gums who have not smoked for 5 years
Detailed Description:
This study is planned to be conducted with 45 individuals aged between 18-65 who applied to Necmettin Erbakan University Faculty of Dentistry Department of Periodontology for various reasons In the Department of Periodontology each patient diagnosed with periodontal disease after clinical and radiological evaluation is initially treated with phase-1 treatment In addition the treatment of patients with mucogingival problems gingival recession keratinized gingival insufficiency shallow vestibule depth whose phase-1 treatment has been completed in our periodontology clinic continues with free gingival graft and connective tissue graft surgery etc Pre- and post-operative clinical measurements and photographs of patients for whom surgical procedures are planned are taken and kept in our archive
In this prospectively planned study the palatal area of patients who have received an indication for free gingival surgery for any reason and who meet the inclusion criteria and have agreed to participate in the study will be scanned with an intraoral scanner before and after the procedure and the changes in palate volume will be monitored at 1st and 3rd month follow-ups
Inclusion and exclusion criteria limitations
Study inclusion criteria
1 Volunteers aged 18 and over
2 Patients with Cairo type I gingival recession and requiring free gingival surgery
3 Not having a psychiatric mental or physical disability
4 Not having received periodontal treatment in the last 6 months
5 Being systemically healthy
6 Having at least 20 teeth in your entire mouth
7 Getting diagnosed with healthy gums
8 Not using any medication
9 Not being pregnant
10 Not having used any antibiotics anti-inflammatory or any other drugs that may affect periodontal tissues in the last 6 months for any reason
Exclusion criteria from the study
1 Being outside the inclusion criteria and not agreeing to participate in the study individual selection If the patients who come to the Periodontology Clinic Secretariat for periodontal treatment meet the inclusion criteria of the study whose Phase-1 treatment has been completed the patients who accept the study and those who sign the consent form will be included in the study
Considering the possibility of participants dropping out of the study the number of individuals to be included in each group was determined as 15 and it is planned to be conducted with 45 individuals in total
Group 1 Patients who are non-smokers and have clinically healthy gums Group 2 Light smokers who report smoking less than 5 cigarettes per day and patients with clinically healthy gums Group 3 Patients with clinically healthy gums and ex-smokers who have not smoked for 5 years
An intraoral optical scanner TRIOS 3Shape will be used to obtain digital models as STL files at baseline before surgery and at 1 and 3 months STL files will be imported into a digital imaging software Geomagic Control X to measure donor site volume changes over time All digital volumetric analyzes will be performed STL files from baseline and follow-up visits will be overlaid and matched using the most appropriate algorithm Stable anatomical landmarks teeth and contralateral palate will be used to perform overlay of models to guarantee maximum accuracy of digital analysis Observed volumetric results are planned to include average volumetric Volume changes average distance between surfaces difference in average thickness of the reconstructed volume DD and linear dimensional changes LD at points 3 5 and 7 mm Patient age gender and graft dimensions width height and thickness will also be recorded The primary outcome of this study is to observe the post-operative dimensional changes of donor areas at different follow-up periods by evaluating them in volumetric and linear dimensions The secondary outcome is to evaluate volumetric outcomes such as gender age and graft size together with patient including smoking and surgery-related factors that may affect the outcome
In this prospectively planned study the palatal area of patients who have received an indication for free gingival surgery for any reason and who meet the inclusion criteria and have agreed to participate in the study will be scanned with an intraoral scanner before and after the procedure and the changes in palate volume will be monitored at 1st and 3rd month follow-ups
Inclusion and exclusion criteria limitations
Study inclusion criteria
1 Volunteers aged 18 and over
2 Patients with Cairo type I gingival recession and requiring free gingival surgery
3 Not having a psychiatric mental or physical disability
4 Not having received periodontal treatment in the last 6 months
5 Being systemically healthy
6 Having at least 20 teeth in your entire mouth
7 Getting diagnosed with healthy gums
8 Not using any medication
9 Not being pregnant
10 Not having used any antibiotics anti-inflammatory or any other drugs that may affect periodontal tissues in the last 6 months for any reason
Exclusion criteria from the study
1 Being outside the inclusion criteria and not agreeing to participate in the study individual selection If the patients who come to the Periodontology Clinic Secretariat for periodontal treatment meet the inclusion criteria of the study whose Phase-1 treatment has been completed the patients who accept the study and those who sign the consent form will be included in the study
Considering the possibility of participants dropping out of the study the number of individuals to be included in each group was determined as 15 and it is planned to be conducted with 45 individuals in total
Group 1 Patients who are non-smokers and have clinically healthy gums Group 2 Light smokers who report smoking less than 5 cigarettes per day and patients with clinically healthy gums Group 3 Patients with clinically healthy gums and ex-smokers who have not smoked for 5 years
An intraoral optical scanner TRIOS 3Shape will be used to obtain digital models as STL files at baseline before surgery and at 1 and 3 months STL files will be imported into a digital imaging software Geomagic Control X to measure donor site volume changes over time All digital volumetric analyzes will be performed STL files from baseline and follow-up visits will be overlaid and matched using the most appropriate algorithm Stable anatomical landmarks teeth and contralateral palate will be used to perform overlay of models to guarantee maximum accuracy of digital analysis Observed volumetric results are planned to include average volumetric Volume changes average distance between surfaces difference in average thickness of the reconstructed volume DD and linear dimensional changes LD at points 3 5 and 7 mm Patient age gender and graft dimensions width height and thickness will also be recorded The primary outcome of this study is to observe the post-operative dimensional changes of donor areas at different follow-up periods by evaluating them in volumetric and linear dimensions The secondary outcome is to evaluate volumetric outcomes such as gender age and graft size together with patient including smoking and surgery-related factors that may affect the outcome
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