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

Primary Purpose

Tooth Extraction Status Nos, Tooth Fracture

Status
Recruiting
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
PRF
Curcuma Longa gel
extraction socket
Sponsored by
Rania Farouk Mohamed Abdulmaguid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Extraction Status Nos

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts 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. 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.

Sites / Locations

  • Rania FaroukRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Active Comparator

Active Comparator

Arm Label

Control

PRF Group

Curcuma Longa Group

Arm Description

extraction socket .

extraction socket and PRF

Extraction Socket and Curcuma Longa

Outcomes

Primary Outcome Measures

Soft tissue healing
Healing index (change is being assessed)

Secondary Outcome Measures

Bone Density
CBCT (change is being assessed)

Full Information

First Posted
March 19, 2023
Last Updated
April 17, 2023
Sponsor
Rania Farouk Mohamed Abdulmaguid
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1. Study Identification

Unique Protocol Identification Number
NCT05816707
Brief Title
The Assessment of Curcuma Longa Potentials for Soft and Hard Tissue Healing in Fresh
Official Title
The Assessment of Curcuma Longa Potentials for Soft and Hard Tissue Healing in Fresh Extraction Sockets; Randomized Controlled Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Anticipated)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Rania Farouk Mohamed Abdulmaguid

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 curcumin/PRF 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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Extraction Status Nos, Tooth Fracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled clinical trial.
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Other
Arm Description
extraction socket .
Arm Title
PRF Group
Arm Type
Active Comparator
Arm Description
extraction socket and PRF
Arm Title
Curcuma Longa Group
Arm Type
Active Comparator
Arm Description
Extraction Socket and Curcuma Longa
Intervention Type
Biological
Intervention Name(s)
PRF
Intervention Description
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
Intervention Name(s)
Curcuma Longa gel
Intervention Description
Curcuma Longa gel
Intervention Type
Other
Intervention Name(s)
extraction socket
Intervention Description
extraction socket
Primary Outcome Measure Information:
Title
Soft tissue healing
Description
Healing index (change is being assessed)
Time Frame
21 days after surgery
Secondary Outcome Measure Information:
Title
Bone Density
Description
CBCT (change is being assessed)
Time Frame
3 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rania Farouk, Doctoral
Phone
01278118900
Email
rfarouk@msa.edu.eg
Facility Information:
Facility Name
Rania Farouk
City
Cairo
ZIP/Postal Code
12855
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rania Farouk, Doctoral
Phone
01278118900
Email
rfarouk@msa.edu.eg

12. IPD Sharing Statement

Learn more about this trial

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

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