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Completed

NCT Number: NCT05122299

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

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.

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Key information

Conditions

Dental Implants

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alexandria Faculty of Dentistry

Alexandria, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Negative control group

Procedure

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

Postive control

Procedure

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

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.

Primary outcomes

  1. Soft tissue healing

    Time frame: 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.

  2. change in bone formation

    Time frame: 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.

  3. Change in implant stability

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hams Hamed Abdelrahman

Other

Registry information

Official study 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)

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 16, 2021
Registry last updated
Nov 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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