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the Effect of coenzymeq10/Collagen Hydrogel on Bone Regeneration in Extraction Socket

NCT ID: NCT05122299

Last Updated: 2021-11-16

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

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-28

Study Completion Date

2021-09-01

Brief Summary

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To investigate the effect of CoQ10 in soft tissue healing and bone regeneration after extraction in diabetic patients seeking dental implants. Methods: This study will be a randomized controlled clinical trial, 18 patients will be divided equally into three groups. In-vitro studies will be performed to investigate the release of CoQ10 from collagen, swelling ratio, and evaluation of gelation behavior. The patients will undergo tooth extraction and filling of the socket with either collagen or CoQ10/collagen. Empty sockets will serve as a negative control. The bone regeneration of the socket will be determined by radiography, histology, histomorphometry, and polymerase chain reaction (PCR) for bone markers.

Detailed Description

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Conditions

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Dental Implants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Negative control group

Group Type OTHER

Negative control group

Intervention Type PROCEDURE

No intervention after extraction then delayed implant insertion at the site of extraction after three months

Positive control group

Group Type ACTIVE_COMPARATOR

Postive control

Intervention Type PROCEDURE

Application of collagen only in the socket after extraction then delayed implant insertion at the site of extraction after three months.

Study group

Group Type EXPERIMENTAL

Study group

Intervention Type PROCEDURE

Application of acombination of CoQ10 and collagen hydrogel in the socket after extraction then delayed implant insertion at the site of extraction after three months.

Interventions

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Negative control group

No intervention after extraction then delayed implant insertion at the site of extraction after three months

Intervention Type PROCEDURE

Postive control

Application of collagen only in the socket after extraction then delayed implant insertion at the site of extraction after three months.

Intervention Type PROCEDURE

Study group

Application of acombination of CoQ10 and collagen hydrogel in the socket after extraction then delayed implant insertion at the site of extraction after three months.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age 30-60 years including both males and females .
* Controlled Type II diabetic patients glycosylated hemoglobin (HbA1C) levels less than 7
* Good oral hygiene
* No history of bruxism/ para-functional habits
* Patients accept to sign the informed consent .
* Single or multiple Mandibular teeth requiring extraction.

Exclusion Criteria

* Uncontrolled diseases that may contraindicate the surgery.
* Somkers patients.
* Osteoporosis.
* Hypersensitivity.
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hams Hamed Abdelrahman

OTHER

Sponsor Role lead

Responsible Party

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Hams Hamed Abdelrahman

Assistant lecturer of DPH and Clinical statistician

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Alexandria Faculty of Dentistry

Alexandria, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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implants_20_21

Identifier Type: -

Identifier Source: org_study_id