The Effect of Local Aplication of Cayanoacrylate Tissue Adhesives on Improving the HealingNCT04780360
Cyanoacrylate Tissue Adhesives Versus Silk Suture at the Palatal Donor Site of Sub Epithelial Connective Tissue Graft
A study testing Cayanoacrylate tissue adhesives and Silk suture in people with The Effect of Local Aplication of Cayanoacrylate Tissue Adhesives on Improving the Healing, run by Cairo University at 1 site in Egypt.
Trial summary
Subepithelial connective tissue grafts (CTG) are considered the gold standard procedure with proven clinical success when it comes to gingival augmentation aims to to improve periodontal health, which can enhance the long-term prognosis of teeth by obtaining soft tissue coverage of exposed root surfaces and/or… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- The Effect of Local Aplication of Cayanoacrylate Tissue Adhesives on Improving the Healing
- What is being tested?
- Cayanoacrylate tissue adhesives and Silk suture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2021to 1 Dec 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with mucogingival defects scheduled for sub epithelial connective tissue graft
- Age at least 18 years.
- Not having any systemic disease that could compromise wound healing
- No periodontal surgery on the experimental sites.
- No smoking,
- No pregnancy or lactation
Who cannot join
- Patients with coagulation disorders
- patients on corticosteroids, with uncontrolled diabetes, or with any systemic disease that precluded periodontal surgery
- patients with a history of contact dermatitis to formaldehyde
- Loss of maxillary premolars and molars
- Medications or antibiotics used in the previous 6 months
- Pregnancy or lactation
- Smoking
Trial locations and contacts
1 site in 1 country.
Mohamed S Mohamed Ibrahium Abdullah, Invistegator contact
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Cairo Universty
Cairo, 0000
Hassan Ahmed, Adminstrator, 23634965 ext. 02, hassan.ahmed@dentistry.cu.edu.eg
About this study
Official title: Evaluation of Post Operative Pain, Early Wound Healing, and the Time of Application of Cyanoacrylates Tissue Adhesives Versus Silk Sutures at the Palatal Donor Area of Subepithelial Connective Tissue Grafts (CTG) A Randomized Clinical Trial: Comparative Study
Subepithelial connective tissue grafts (CTG) are considered the gold standard procedure with proven clinical success when it comes to gingival augmentation aims to to improve periodontal health, which can enhance the long-term prognosis of teeth by obtaining soft tissue coverage of exposed root surfaces and/or augmentation the dimensions of gingival tissue. The procedure require harvesting tissue from a the palate, which increases the complexity of the procedure and patient discomfort. Complications after harvesting a graft would be pain, inflammation, bleeding, flap necrosis and infection in the donor site.
- Conditions
- The Effect of Local Aplication of Cayanoacrylate Tissue Adhesives on Improving the Healing
- Being tested
- Cayanoacrylate tissue adhesives, Silk suture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cayanoacrylate tissue adhesivesProcedure or surgery
Cyanoacrylates are a family of strong fast-acting adhesives with industrial, medical, and household uses. They are various esters of cyanoacrylic acid. The acryl groups in the resin rapidly polymerize in the presence of water to form long, strong chains
Silk sutureProcedure or surgery
Non Absorbalble suture materiel used to fixed the edges of the incision in place until healing
| Study group | Role | What they receive |
|---|---|---|
| Cayanoacrylate tissue adhesives | Experimental | thin layers of high viscosity blend of n-butyl and 2-octyl cayanoacrylate tissue adhesive will be applied and rinsed with saline at least three times with interval of at least 30 seconds Receives: Procedure: Cayanoacrylate tissue adhesives |
| Silk suture material | Active comparator | interrupted knots Receives: Procedure: Silk suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Wound Healing
Measured By Modified Early Wound Healing Index
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start1 Feb 2021
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Effect of Local Aplication of Cayanoacrylate Tissue Adhesives on Improving the HealingStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Saeed Mohamed Ibrahuim Abdullah, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04780360
- Sponsor's protocol ID
- 567
- Status last verified
- Mar 2021
- First submitted
- 17 Nov 2019
- Last updated
- 8 Mar 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 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Post Operative Pain, Early Wound Healing, and the Time of Application of Cyanoacrylates Tissue Adhesives Versus Silk Sutures at the Palatal Donor Area of Subepithelial Connective Tissue Grafts (CTG) A Randomized Clinical Trial: Comparative Study
- ClinicalTrials.gov ID
- NCT04780360
- Acronym / sponsor ID
- 567
- Conditions
- The Effect of Local Aplication of Cayanoacrylate Tissue Adhesives on Improving the Healing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 3 Mar 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.
Subepithelial connective tissue grafts (CTG) are considered the gold standard procedure with proven clinical success when it comes to gingival augmentation aims to to improve periodontal health, which can enhance the long-term prognosis of teeth by obtaining soft tissue coverage of exposed root surfaces and/or augmentation the dimensions of gingival tissue. The procedure require harvesting tissue from a the palate, which increases the complexity of the procedure and patient discomfort. Complications after harvesting a graft would be pain, inflammation, bleeding, flap necrosis and infection in the donor site.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cayanoacrylate tissue adhesives | Experimental | Procedure: Cayanoacrylate tissue adhesivesthin layers of high viscosity blend of n-butyl and 2-octyl cayanoacrylate tissue adhesive will be applied and rinsed with saline at least three times with interval of at least 30 seconds |
| Silk suture material | Active comparator | Procedure: Silk sutureinterrupted knots |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients with mucogingival defects scheduled for sub epithelial connective tissue graft
- Age at least 18 years.
- Not having any systemic disease that could compromise wound healing
- No periodontal surgery on the experimental sites.
- No smoking,
Key exclusion criteria (7 listed)
- Patients with coagulation disorders
- patients on corticosteroids, with uncontrolled diabetes, or with any systemic disease that precluded periodontal surgery
- patients with a history of contact dermatitis to formaldehyde
- Loss of maxillary premolars and molars
- Medications or antibiotics used in the previous 6 months
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 |
|---|---|---|
| Cayanoacrylate tissue adhesivesCyanoacrylates are a family of strong fast-acting adhesives with industrial, medical, and household uses. They are various esters of cyanoacrylic acid. The acryl groups in the resin rapidly polymerize in the presence of water to form long, strong chains | Procedure or surgery | Cayanoacrylate tissue adhesives |
| Silk sutureNon Absorbalble suture materiel used to fixed the edges of the incision in place until healing | Procedure or surgery | Silk suture material |
Primary outcome
Early Wound Healing
Time frame: 1 week
Measured By Modified Early Wound Healing Index
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2021.
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.
Mohamed S Mohamed Ibrahium Abdullah, Invistegator contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cayanoacrylate tissue adhesives and Silk suture in people with The Effect of Local Aplication of Cayanoacrylate Tissue Adhesives on Improving the Healing, run by Cairo University 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 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 8 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed S Mohamed Ibrahium Abdullah, Invistegator (01283626196 ext. 02, dr.mohamed15.ms@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early Wound Healing (time frame: 1 week). 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 8 Mar 2021.