Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06567548
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
Clinical Comparison of Alb-PRF vs PRF on Postoperative Morbidity Following FGG Harvesting
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Clinical Comparison of Albumin Platelet Rich- Fibrin Alb-PRF Versus Platelet-rich Fibrin PRF on Postoperative Morbidity Following Free Gingival Graft Harvesting A Randomized Controlled Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
Clinical Comparison of Albumin Platelet Rich- Fibrin Alb- PRF versus Platelet-rich fibrin PRF on Postoperative Morbidity Following Free Gingival Graft Harvesting A Randomized Controlled Clinical TrialRCT
Study settings
The study will be conducted in the Oral Medicine and Periodontology department Faculty of Dentistry - Cairo University Egypt
Patients will be selected from the Department of Oral Medicine and Periodontology-Cairo University outpatient clinic
Expected Duration of Participation and Number of Participants Research Duration 28 days Number of Participants 39 volunteers
Work Plan
During the first visit preoperative photographs will be taken Then participants will be randomly assigned using a website into three groups
Group A Application of Alb-PRF at the donor site of the free gingival graft Group B Application of PRF at the donor site of the free gingival graft Control Application of Gelatin Sponge at the donor site
10 ml of venous blood will be drawn from the patient to prepare Alb-PRF and PRF membranes for placement at the donor site
The membrane or gelatin sponge will be placed at the donor site and sutured
Postoperative Protocol
After surgery patients will be instructed to take 600 mg of ibuprofen and 012 chlorhexidine gluconate mouthwash for two weeks postoperatively
Analgesics will be recommended only if there is pain and no antibiotics will be prescribed
Patients will receive verbal and written dietary advice postoperatively They will be encouraged to avoid heat sources and adhere to a diet of cold and soft foods
Cleaning the adjacent palatal side of the surgical site will be prohibited to avoid irritation while gentle cleaning will be recommended after dressing removal
In case of postoperative problems such as unusual bleeding or gum recession patients will be provided with contact information for their physician for early intervention
During Visual Analog Scale VAS pain recording patients will be instructed only to describe pain from the palate and to track additional analgesic intake and consumed tablets Follow-up visits will be scheduled on days 3 7 14 21 and 28 postoperatively
Postoperative Follow-up
Palatal sutures will be removed after 7 days post-surgery On days 14 21 and 28 wound healing tissue color match complete re-epithelialization of the wound and clinical wound healing area will be monitored
Study settings
The study will be conducted in the Oral Medicine and Periodontology department Faculty of Dentistry - Cairo University Egypt
Patients will be selected from the Department of Oral Medicine and Periodontology-Cairo University outpatient clinic
Expected Duration of Participation and Number of Participants Research Duration 28 days Number of Participants 39 volunteers
Work Plan
During the first visit preoperative photographs will be taken Then participants will be randomly assigned using a website into three groups
Group A Application of Alb-PRF at the donor site of the free gingival graft Group B Application of PRF at the donor site of the free gingival graft Control Application of Gelatin Sponge at the donor site
10 ml of venous blood will be drawn from the patient to prepare Alb-PRF and PRF membranes for placement at the donor site
The membrane or gelatin sponge will be placed at the donor site and sutured
Postoperative Protocol
After surgery patients will be instructed to take 600 mg of ibuprofen and 012 chlorhexidine gluconate mouthwash for two weeks postoperatively
Analgesics will be recommended only if there is pain and no antibiotics will be prescribed
Patients will receive verbal and written dietary advice postoperatively They will be encouraged to avoid heat sources and adhere to a diet of cold and soft foods
Cleaning the adjacent palatal side of the surgical site will be prohibited to avoid irritation while gentle cleaning will be recommended after dressing removal
In case of postoperative problems such as unusual bleeding or gum recession patients will be provided with contact information for their physician for early intervention
During Visual Analog Scale VAS pain recording patients will be instructed only to describe pain from the palate and to track additional analgesic intake and consumed tablets Follow-up visits will be scheduled on days 3 7 14 21 and 28 postoperatively
Postoperative Follow-up
Palatal sutures will be removed after 7 days post-surgery On days 14 21 and 28 wound healing tissue color match complete re-epithelialization of the wound and clinical wound healing area will be monitored
Detailed Description:
General Operative Procedures Preoperative Evaluation
Intra-Oral Examination Confirm the patients eligibility based on predefined criteria
Phase I Therapy Perform thorough supragingival scaling and subgingival debridement
Plaque Control Ensure the patient maintains proper mechanical and chemical plaque control
Clinical Procedure Free Gingival Graft FGG Harvesting
Preparation All procedures will be done under sterile conditions and local anesthesia
FGG Harvesting
FGG will be harvested from the palate
Make two horizontal incisions coronal incision 2mm above the gingival margin and two vertical incisions to outline the graft area
Insert a blade along the coronal incision perpendicular to the bone then move parallel to the hard palate in a mesiodistal direction to detach the graft while maintaining uniform thickness and avoiding the palatal periosteum
Place the graft on sterile saline gauze to prevent shrinkage
Control Group
Apply an absorbable gelatin sponge to the wound after FGG harvesting
Secure with compressive palatal sling sutures 5-0 polypropylene
PRF Group
PRF Preparation Collect 10 ml of intravenous blood and centrifuge at 3000 Rounds Per Minute RPM for 10 minutes Extract the PRF clot and form a membrane
Apply the PRF membrane over the donor site and secure it with criss-cross sutures 5-0 polypropylene
Alb-PRF Group
Alb-PRF Preparation Collect 10 ml of intravenous blood and centrifuge at 700 RPM for 8 minutes Heat the upper layer to 75C for 10 minutes to form albumin gel then cool
Mix the albumin gel with liquid PRF to form Alb-PRF
Apply the Alb-PRF membrane over the donor site and secure it with criss-cross sutures 5-0 polypropylene
Postsurgical Care
Pain Management Take Ibuprofen 600 mg as needed
Mouthwash Use 012 chlorhexidine gluconate for two weeks
Dietary Instructions Follow a cold soft diet avoid hot foods
Oral Hygiene Avoid brushing near the surgical site gentle brushing is allowed after pack removal
Emergency Contact Provided for issues like abnormal bleeding
Pain Assessment Use the Visual Analog Scale VAS to assess pain in the palate
Follow-Up Scheduled for 3 7 14 21 and 28 days post-surgery
Suture Removal 7 days after surgery
Intra-Oral Examination Confirm the patients eligibility based on predefined criteria
Phase I Therapy Perform thorough supragingival scaling and subgingival debridement
Plaque Control Ensure the patient maintains proper mechanical and chemical plaque control
Clinical Procedure Free Gingival Graft FGG Harvesting
Preparation All procedures will be done under sterile conditions and local anesthesia
FGG Harvesting
FGG will be harvested from the palate
Make two horizontal incisions coronal incision 2mm above the gingival margin and two vertical incisions to outline the graft area
Insert a blade along the coronal incision perpendicular to the bone then move parallel to the hard palate in a mesiodistal direction to detach the graft while maintaining uniform thickness and avoiding the palatal periosteum
Place the graft on sterile saline gauze to prevent shrinkage
Control Group
Apply an absorbable gelatin sponge to the wound after FGG harvesting
Secure with compressive palatal sling sutures 5-0 polypropylene
PRF Group
PRF Preparation Collect 10 ml of intravenous blood and centrifuge at 3000 Rounds Per Minute RPM for 10 minutes Extract the PRF clot and form a membrane
Apply the PRF membrane over the donor site and secure it with criss-cross sutures 5-0 polypropylene
Alb-PRF Group
Alb-PRF Preparation Collect 10 ml of intravenous blood and centrifuge at 700 RPM for 8 minutes Heat the upper layer to 75C for 10 minutes to form albumin gel then cool
Mix the albumin gel with liquid PRF to form Alb-PRF
Apply the Alb-PRF membrane over the donor site and secure it with criss-cross sutures 5-0 polypropylene
Postsurgical Care
Pain Management Take Ibuprofen 600 mg as needed
Mouthwash Use 012 chlorhexidine gluconate for two weeks
Dietary Instructions Follow a cold soft diet avoid hot foods
Oral Hygiene Avoid brushing near the surgical site gentle brushing is allowed after pack removal
Emergency Contact Provided for issues like abnormal bleeding
Pain Assessment Use the Visual Analog Scale VAS to assess pain in the palate
Follow-Up Scheduled for 3 7 14 21 and 28 days post-surgery
Suture Removal 7 days after surgery
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