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

Rania Farouk Mohamed Abdulmaguid

Status and phase: Enrolling; Phase 1

Conditions: Tooth Fracture; Tooth Extraction Status Nos

Treatments: Biological: PRF; Biological: Curcuma Longa gel; Other: extraction socket

Study type: Interventional

Funder types: Other

Identifiers

NCT05816707

REC-D652-3

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

  3. Patients with no signs or symptoms of acute periapical\ periodontal infection.

  4. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 3 patient groups

Control

Other group

Description:

extraction socket .

Treatment:

Other: extraction socket

PRF Group

Active Comparator group

Description:

extraction socket and PRF

Treatment:

Biological: PRF

Other: extraction socket

Curcuma Longa Group

Active Comparator group

Description:

Extraction Socket and Curcuma Longa

Treatment:

Biological: Curcuma Longa gel

Other: extraction socket