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

NCT ID: NCT05816707

Last Updated: 2024-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2025-08-01

Brief Summary

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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

Detailed Description

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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.

Conditions

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Tooth Extraction Status Nos Tooth Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled clinical trial.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Control

extraction socket .

Group Type OTHER

extraction socket

Intervention Type OTHER

extraction socket

PRF Group

extraction socket and PRF

Group Type ACTIVE_COMPARATOR

PRF

Intervention Type BIOLOGICAL

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

extraction socket

Intervention Type OTHER

extraction socket

Curcuma Longa Group

Extraction Socket and Curcuma Longa

Group Type ACTIVE_COMPARATOR

Curcuma Longa gel

Intervention Type BIOLOGICAL

Curcuma Longa gel

extraction socket

Intervention Type OTHER

extraction socket

Interventions

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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

Intervention Type BIOLOGICAL

Curcuma Longa gel

Curcuma Longa gel

Intervention Type BIOLOGICAL

extraction socket

extraction socket

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rania Farouk Mohamed Abdulmaguid

OTHER

Sponsor Role lead

Responsible Party

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Rania Farouk Mohamed Abdulmaguid

Associate Professor Oral medicine and periodontology faculty of dentistry MSA university

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Rania Farouk

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Rania Farouk, Doctoral

Role: CONTACT

01278118900

Facility Contacts

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Rania Farouk, Doctoral

Role: primary

01278118900

Other Identifiers

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REC-D652-3

Identifier Type: -

Identifier Source: org_study_id

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