The Assessment of Curcuma Longa Potentials for Soft and Hard Tissue Healing in Fresh

Tooth Extraction Status Nos Clinical Trial

Official title:

The Assessment of Curcuma Longa Potentials for Soft and Hard Tissue Healing in Fresh Extraction Sockets; Randomized Controlled Clinical Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05816707
• Other study ID #: REC-D652-3
• Status: Recruiting
• Phase: Phase 1
• Start date: May 1, 2024
• Est. completion date: August 1, 2025

Study information

• Verified date: March 2024
• Source: October University for Modern Sciences and Arts
• Contact: Rania Farouk, Doctoral
• Phone: 01278118900
• Email: rfarouk[@]msa.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 curcumin/PRF and the other side will be control soft tissue healing and bone quality will be evaluated post-operative

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 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 1, 2025
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Tooth Extraction Status Nos
• Tooth Fracture
• Tooth Fractures

Intervention

Biological:
• PRF
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
• Curcuma Longa gel
Curcuma Longa gel

Other:
• extraction socket
extraction socket

Locations

Country	Name	City	State
Egypt	Rania Farouk	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Rania Farouk Mohamed Abdulmaguid

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Soft tissue healing	Healing index (change is being assessed)	21 days after surgery
Secondary	Bone Density	CBCT (change is being assessed)	3 months after surgery