Soft Tissue AtrophyNCT04063475
Cyanoacrylate With Sutures for Fixation of Free Gingival Graft
A study testing cyanoacrylate tissue adhesive beside sutures in people with Soft Tissue Atrophy, run by Cairo University.
Trial summary
fixation of FGG with sutures alone is not sufficient,we use cyanoacrylate beside sutures for fixation Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Soft Tissue Atrophy
- What is being tested?
- cyanoacrylate tissue adhesive beside sutures
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 16 Sep 2019to Jun 2020
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with hopeless teeth that need extraction
- Age: between 20 and 60 years
- Both sexes.
- Subjects willing to sign an informed consent form ,participate in the study and return for follow-up visits
Who cannot join
- • Patients with coagulation disorders (Hemophilia a/b, von Willebrand disease, liver disease, anticoagulative therapy),
- patients on corticosteroids,
- patients with uncontrolled diabetes mellitus
- smokers
- Pregnant or lactating mother.
- Known systemic diseases and/ or drug therapy which may interfere with wound healing or contraindicate periodontal therapy
- Allergy to cyanoacrylate
About this study
Official title: Cyanoacrylate Tissue Adhesive Assisted Soft Tissue Stabilization: a Novel Technique for Free Gingival Graft Fixation (Case Series Study)
fixation of FGG with sutures alone is not sufficient,we use cyanoacrylate beside sutures for fixation
Read the detailed description
Inadequate zone of attached mucosa around implants, gingival recession, inadequate ridge width or height despite there is enouph bone for implant placement are problems that face periodontists and can be treated by soft tissue graft Studies have demonstrated the importance of the tissues stability for the first hours when support is provided by underlying osseous or dental structures.
Movement of the graft during mastication and phonation will disturb healing procedures. Most of the clinicians prefer a protective device during the healing phase.
Transitional dentures are not stable themselves, and hence are not suitable for stabilizing.
Circummandibular wiring and impact posts are seemingly very aggressive for patients and need extra clinical practices, skills, and equipment.
Studies proved that the maximum tissue shrinkage (approximately 20%-40%) occurs during the first 3 months post operation and will proceed until 12 postsurgical months with a persistent, significantly lower rate.
In this study we give more stabilization for free gingival grafts by using cyanoacrylate tissue adhesive beside sutures Its autogenous character, maintenance of keratinization, predictability, ease of technique tlead CTG to be accepted as the golden standard to increase attached gingival dimensions Cyanoacrylate is a simple, inexpensive haemostatic and biocompatible material It is used as tissue adhesives in paediatric surgery general surgery and also dentistry.
it has been applied intraorally with different purposes such as periodontal dressing,for sealing sinus membrane perforations for stabilizing bone fragments during fracture fixation, and in closing peripheral nerve anastomosis it seems promising in the intraoral field due to their strong sealing, bacteriostatic, and hemostatic properties. Multiple studies examined the use of cyanoacrylate glues as an alternative to suturing intraoral and extraoral wounds concluding that cyanoacrylates are faster, more reliable ,and less painful and cause better hemostasis .
- Conditions
- Soft Tissue Atrophy
- Being tested
- cyanoacrylate tissue adhesive beside sutures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cyanoacrylate tissue adhesive beside suturesDrug
Also called tissue adhesive
using cyanoacrylate tissue adhesive for FGG fixation
| Study group | Role | What they receive |
|---|---|---|
| cyanoacrylate beside sutures for FGG fixation | Experimental | butyl cyanoacrylate Receives: Drug: cyanoacrylate tissue adhesive beside sutures |
What is being measured
The primary outcome is the main question the study is designed to answer.
graft shrinkage in millimeter
graft area ,thickness in millimeter
Measured: 2 weeks,month,3months
Secondary outcomes (1)
success percentage
% percentage (success of Free Gingival Graft Fixation)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2019
- Study start16 Sep 2019 (estimated)
- Primary completionJun 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue AtrophyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Cyanoacrylate beside sutures for Fixation of FGG
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, haytham mohamed ahmed ibrahim, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04063475
- Sponsor's protocol ID
- cyanoacrylate in FGG
- Status last verified
- Jun 2019
- First submitted
- 16 Jun 2019
- Last updated
- 21 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cyanoacrylate Tissue Adhesive Assisted Soft Tissue Stabilization: a Novel Technique for Free Gingival Graft Fixation (Case Series Study)
- ClinicalTrials.gov ID
- NCT04063475
- Acronym / sponsor ID
- cyanoacrylate in FGG
- Conditions
- Soft Tissue Atrophy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 16 Sep 2019 (estimated)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 21 Aug 2019 (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.
fixation of FGG with sutures alone is not sufficient,we use cyanoacrylate beside sutures for fixation
Detailed description
Inadequate zone of attached mucosa around implants, gingival recession, inadequate ridge width or height despite there is enouph bone for implant placement are problems that face periodontists and can be treated by soft tissue graft Studies have demonstrated the importance of the tissues stability for the first hours when support is provided by underlying osseous or dental structures.
Movement of the graft during mastication and phonation will disturb healing procedures. Most of the clinicians prefer a protective device during the healing phase.
Transitional dentures are not stable themselves, and hence are not suitable for stabilizing.
Circummandibular wiring and impact posts are seemingly very aggressive for patients and need extra clinical practices, skills, and equipment.
Studies proved that the maximum tissue shrinkage (approximately 20%-40%) occurs during the first 3 months post operation and will proceed until 12 postsurgical months with a persistent, significantly lower rate.
In this study we give more stabilization for free gingival grafts by using cyanoacrylate tissue adhesive beside sutures Its autogenous character, maintenance of keratinization, predictability, ease of technique tlead CTG to be accepted as the golden standard to increase attached gingival dimensions Cyanoacrylate is a simple, inexpensive haemostatic and biocompatible material It is used as tissue adhesives in paediatric surgery general surgery and also dentistry.
it has been applied intraorally with different purposes such as periodontal dressing,for sealing sinus membrane perforations for stabilizing bone fragments during fracture fixation, and in closing peripheral nerve anastomosis it seems promising in the intraoral field due to their strong sealing, bacteriostatic, and hemostatic properties. Multiple studies examined the use of cyanoacrylate glues as an alternative to suturing intraoral and extraoral wounds concluding that cyanoacrylates are faster, more reliable ,and less painful and cause better hemostasis .
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cyanoacrylate beside sutures for Fixation of FGG
| Arm | Type | Receives |
|---|---|---|
| cyanoacrylate beside sutures for FGG fixation | Experimental | Drug: cyanoacrylate tissue adhesive beside suturesbutyl cyanoacrylate |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with hopeless teeth that need extraction
- Age: between 20 and 60 years
- Both sexes.
- Subjects willing to sign an informed consent form ,participate in the study and return for follow-up visits
Key exclusion criteria (7 listed)
- • Patients with coagulation disorders (Hemophilia a/b, von Willebrand disease, liver disease, anticoagulative therapy),
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 |
|---|---|---|
| cyanoacrylate tissue adhesive beside suturesAlso: tissue adhesiveusing cyanoacrylate tissue adhesive for FGG fixation | Drug | cyanoacrylate beside sutures for FGG fixation |
Primary outcome
graft shrinkage in millimeter
Time frame: 2 weeks,month,3months
graft area ,thickness in millimeter
1 secondary outcome
success percentage
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2019.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing cyanoacrylate tissue adhesive beside sutures in people with Soft Tissue Atrophy, run by Cairo University.
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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 21 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
graft shrinkage in millimeter (time frame: 2 weeks,month,3months). 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 21 Aug 2019.