Ignite Creation Date:
2024-05-06 @ 6:53 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05816707
Status:
RECRUITING
Last Update Posted:
2024-03-13
First Post:
2023-03-19
Brief Title:
The Assessment of Curcuma Longa Potentials for Soft and Hard Tissue Healing in Fresh
Sponsor:
Rania Farouk Mohamed Abdulmaguid
Organization:
October University for Modern Sciences and Arts
Study Overview
Official Title:
The Assessment of Curcuma Longa Potentials for Soft and Hard Tissue Healing in Fresh Extraction Sockets Randomized Controlled Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-03
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:
The study will be conducted on 30 patients with split mouth design patients will be divided into curcumin and PRF groups patients will have bilateral tooth extraction one side will receive curcuminPRF and the other side will be control soft tissue healing and bone quality will be evaluated post-operative
Detailed Description:
30 Patients will be collected from the outpatient clinic of the Department of Oral Maxillofacial surgery Faculty of Dentistry MSA University Cairo Egypt
Eligibility criteria
Inclusion Criteria for participants
1 Patients with bilateral badly decayed mandibular posterior tooth that need extraction
2 Patients free from any systemic disease
3 Patients who approved to be included in the trial and signed the informed consent
4 Patients with no signs or symptoms of acute periapical periodontal infection
5 Adults aged between 18-50 years old
Exclusion criteria for participants
1 Patients who are allergic to Curcumin
2 Smoker patient
3 Patients receiving chemotherapy or radiotherapy
4 Patients who refused to be included in the trial
Interventions
1 Diagnosis
All patients will be diagnosed and selected according to inclusion and exclusion criteria
Comprehensive clinical examination and understanding of patients chief complains and needs will be done
Standard preoperative intra-oral photographs occlusal and lateral
Pre-operative orthopantogram will be taken to ensure absence of any periapical infection
2 Intra-operative procedures
Local anesthesia will be injected intraoral around selected teeth Patients will rinse by antiseptic mouthwash 30 seconds before extraction Teeth will be extracted a-traumatically as possible to avoid any soft tissue or bony damage
The extracted sockets will be debrided by bone curettes and saline The three extraction sockets will be divided into three groups control group curcumin group and PRF group
After curcumin PRF placement all sockets will be closed by simple interrupted suture
3 Postoperative treatment Analgesics every 6 hours for 3 days
4 Concomitant care None needed
5 Follow up Evaluation
The extraction site will be inspected clinically after 3 days for signs of infection
Soft tissue healing and pain score will be assessed after 7 14 and 21 days
3 months post-operatively each patient will undergo radiographic assessment by using Cone Beam Computed Tomography CBCT to evaluate bone healing and bone density
Eligibility criteria
Inclusion Criteria for participants
1 Patients with bilateral badly decayed mandibular posterior tooth that need extraction
2 Patients free from any systemic disease
3 Patients who approved to be included in the trial and signed the informed consent
4 Patients with no signs or symptoms of acute periapical periodontal infection
5 Adults aged between 18-50 years old
Exclusion criteria for participants
1 Patients who are allergic to Curcumin
2 Smoker patient
3 Patients receiving chemotherapy or radiotherapy
4 Patients who refused to be included in the trial
Interventions
1 Diagnosis
All patients will be diagnosed and selected according to inclusion and exclusion criteria
Comprehensive clinical examination and understanding of patients chief complains and needs will be done
Standard preoperative intra-oral photographs occlusal and lateral
Pre-operative orthopantogram will be taken to ensure absence of any periapical infection
2 Intra-operative procedures
Local anesthesia will be injected intraoral around selected teeth Patients will rinse by antiseptic mouthwash 30 seconds before extraction Teeth will be extracted a-traumatically as possible to avoid any soft tissue or bony damage
The extracted sockets will be debrided by bone curettes and saline The three extraction sockets will be divided into three groups control group curcumin group and PRF group
After curcumin PRF placement all sockets will be closed by simple interrupted suture
3 Postoperative treatment Analgesics every 6 hours for 3 days
4 Concomitant care None needed
5 Follow up Evaluation
The extraction site will be inspected clinically after 3 days for signs of infection
Soft tissue healing and pain score will be assessed after 7 14 and 21 days
3 months post-operatively each patient will undergo radiographic assessment by using Cone Beam Computed Tomography CBCT to evaluate bone healing and bone density
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