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

NCT05122299 | Completed

• 1 other identifier: implants_20_21
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Implants

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

Negative control group

OTHER

Procedure: Negative control group

Positive control group

ACTIVE COMPARATOR

Procedure: Postive control

Study group

EXPERIMENTAL

Procedure: Study group

Interventions

Negative control group PROCEDURE

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

Negative control group

Postive control PROCEDURE

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

Positive control group

Study group 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.

Study group

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Uncontrolled diseases that may contraindicate the surgery.
• Somkers patients.
• Osteoporosis.
• Hypersensitivity.

Sponsors & Collaborators

• Hams Hamed Abdelrahman: lead

Study Sites (1)

Alexandria Faculty of Dentistry

Alexandria, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer of DPH and Clinical statistician

Study Record Dates

• First Submitted: November 3, 2021
• First Posted: November 16, 2021
• Study Start: March 28, 2021
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: November 16, 2021

Record last verified: 2021-11

Locations

EG (1)