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

Dental Implants Clinical Trial

Official title:

The Effect of coenzymeq10/Collagen Hydrogel on Bone Regeneration in Extraction Socket Prior to Implant Placement in Type ii Diabetic Patients (A Randomized Controlled Clinical Trial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05122299
• Other study ID #: implants_20_21
• Status: Completed
• Phase: N/A
• Start date: March 28, 2021
• Est. completion date: September 1, 2021

Study information

• Verified date: November 2021
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: September 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Implants

Intervention

Procedure:
• Negative control group
No intervention after extraction then delayed implant insertion at the site of extraction after three months
• Postive control
Application of collagen only in the socket after extraction then delayed implant insertion at the site of extraction after three months.
• 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.

Locations

Country	Name	City	State
Egypt	Alexandria Faculty of Dentistry	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Hams Hamed Abdelrahman

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Soft tissue healing	Landry index will be used to evaluate the parameters of tissue colour, bleeding response to palpation, presence of granulation tissue, characteristics of the incision margins, and the presence of suppuration. This index assesses wound healing using scores from 1 to 5: a wound with very poor healing receives a score of 1, whereas excellent healing receives a score of 5.	at 1 week
Primary	change in bone formation	Conebeam computed tomography (CBCT) will be taken at 3 different timepoints; immediatly after extraction to measure height and width of alveolar bone, before implant placement to place implant in accurate position and to compare it with first one to measure the changes in bone height and width and finally at loading to evaluate marginal bone loss.	at baseline, 3 months and 6 months
Primary	Change in implant stability	Osstell instrument (Integration Diagnostics, Goteborg, Sweden) with Smartpeg™ (Integration Diagnostics, Goteborg, Sweden), a transducer suitable for implants will be used to assess stability of implants by RFA. ISQ (implant stability quotient) will be obtained from the measurement results. During measurement, the Smartpeg™ will be placed over the location of implant prosthesis and the Osstell probe will be approximated to it from the buccal, palatal, mesial and distal aspects of the implant giving four ISQ values. A mean ISQ for each implant is then calculated by averaging the four values.; implant stability quotient or ISQ score in a range of 0-100.	at baseline and 3 months