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

Not Applicable

Completed

• Conditions: Dental Implants
• Interventions: Procedure: Negative control group; Procedure: Postive control; Procedure: Study group

• Registration Number: NCT05122299
• Lead Sponsor: Hams Hamed Abdelrahman

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-28
• Primary Completion: 2021-09-01
• Study Completion: 2021-09-01
• Status Verified: 2021-11
• Study First Submitted: 2021-11-03
• Study First Submitted QC: 2021-11-14
• Last Update Submitted: 2021-11-14
• Study First Posted: 2021-11-16
• Last Update Posted: 2021-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Negative control group	Negative control group	-
Positive control group	Postive control	-
Study group	Study group	-

Primary Outcome Measures

Name	Time	Method
Soft tissue healing	at 1 week	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.
change in bone formation	at baseline, 3 months and 6 months	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.
Change in implant stability	at baseline and 3 months	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.

Trial Locations

Locations (1)

Alexandria Faculty of Dentistry; 🇪🇬 Alexandria, Egypt