- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05816707
The Assessment of Curcuma Longa Potentials for Soft and Hard Tissue Healing in Fresh
The Assessment of Curcuma Longa Potentials for Soft and Hard Tissue Healing in Fresh Extraction Sockets; Randomized Controlled Clinical Trial.
Study Overview
Status
Conditions
Intervention / Treatment
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:
- Patients with bilateral badly decayed mandibular posterior tooth that need extraction.
- Patients free from any systemic disease
- Patients who approved to be included in the trial and signed the informed consent.
- Patients with no signs or symptoms of acute periapical\ periodontal infection.
- Adults aged between 18-50 years old.
Exclusion criteria for participants:
- Patients who are allergic to Curcumin
- Smoker patient
- Patients receiving chemotherapy or radiotherapy.
- Patients who refused to be included in the trial.
Interventions:
Diagnosis
- All patients will be diagnosed and selected according to inclusion and exclusion criteria.
- Comprehensive clinical examination and understanding of patient's 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)
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***
- Postoperative treatment Analgesics **** every 6 hours for 3 days
- Concomitant care None needed.
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 Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Cairo, Egypt, 12855
- Rania Farouk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Control
extraction socket .
|
extraction socket
|
|
Active Comparator: PRF Group
extraction socket and PRF
|
extraction socket
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 |
|
Active Comparator: Curcuma Longa Group
Extraction Socket and Curcuma Longa
|
extraction socket
Curcuma Longa gel
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Soft tissue healing
Time Frame: 21 days after surgery
|
Healing index (change is being assessed)
|
21 days after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bone Density
Time Frame: 3 months after surgery
|
CBCT (change is being assessed)
|
3 months after surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC-D652-3
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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