Dental ImplantsNCT05122299
the Effect of coenzymeq10/Collagen Hydrogel on Bone Regeneration in Extraction Socket
A study testing Study group in people with Dental Implants, run by Hams Hamed Abdelrahman at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Dental Implants
- What is being tested?
- Study group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Mar 2021to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Uncontrolled diseases that may contraindicate the surgery.
- Somkers patients.
- Osteoporosis.
- Hypersensitivity.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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
- Being tested
- Negative control group, Postive control, Study group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative control groupProcedure or surgery
No intervention after extraction then delayed implant insertion at the site of extraction after three months
Postive controlProcedure or surgery
Application of collagen only in the socket after extraction then delayed implant insertion at the site of extraction after three months.
Study groupProcedure or surgery
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 | Role | What they receive |
|---|---|---|
| Negative control group | Other | Not described Receives: Procedure: Negative control group |
| Positive control group | Active comparator | Not described Receives: Procedure: Postive control |
| Study group | Experimental | Not described Receives: Procedure: Study group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: at baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study start28 Mar 2021
- Primary completion1 Sep 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05122299
- Sponsor's protocol ID
- implants_20_21
- Status last verified
- Nov 2021
- First submitted
- 3 Nov 2021
- Last updated
- 16 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05122299
- Acronym / sponsor ID
- implants_20_21
- Conditions
- Dental Implants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 28 Mar 2021 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 16 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Negative control group | Other | Procedure: Negative control group |
| Positive control group | Active comparator | Procedure: Postive control |
| Study group | Experimental | Procedure: Study group |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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 .
Key exclusion criteria (4 listed)
- Uncontrolled diseases that may contraindicate the surgery.
- Somkers patients.
- Osteoporosis.
- Hypersensitivity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Negative control groupNo intervention after extraction then delayed implant insertion at the site of extraction after three months | Procedure or surgery | Negative control group |
| Postive controlApplication of collagen only in the socket after extraction then delayed implant insertion at the site of extraction after three months. | Procedure or surgery | Positive control group |
| Study groupApplication of acombination of CoQ10 and collagen hydrogel in the socket after extraction then delayed implant insertion at the site of extraction after three months. | Procedure or surgery | Study group |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Study group in people with Dental Implants, run by Hams Hamed Abdelrahman at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Soft tissue healing (time frame: at 1 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2021.