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

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)

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.

Study Overview

• Status: Completed
• Conditions: Dental Implants
• Intervention / Treatment: Procedure: Negative control group; Procedure: Postive control; Procedure: Study group

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Alexandria Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study group	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.
Other: Negative control group	Procedure: Negative control group; No intervention after extraction then delayed implant insertion at the site of extraction after three months
Active Comparator: Positive control group	Procedure: Postive control; Application of collagen only in the socket after extraction then delayed implant insertion at the site of extraction after three months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Hams Hamed Abdelrahman

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2021
• Primary Completion (Actual): September 1, 2021
• Study Completion (Actual): September 1, 2021

Study Registration Dates

• First Submitted: November 3, 2021
• First Submitted That Met QC Criteria: November 14, 2021
• First Posted (Actual): November 16, 2021

Study Record Updates

• Last Update Posted (Actual): November 16, 2021
• Last Update Submitted That Met QC Criteria: November 14, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: implants_20_21

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No