NCT04063475

Brief Summary

fixation of FGG with sutures alone is not sufficient,we use cyanoacrylate beside sutures for fixation

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 21, 2019

Completed
26 days until next milestone

Study Start

First participant enrolled

September 16, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

August 21, 2019

Status Verified

June 1, 2019

Enrollment Period

9 months

First QC Date

June 16, 2019

Last Update Submit

August 20, 2019

Conditions

Soft Tissue Atrophy

Outcome Measures

Primary Outcomes (1)

  • graft shrinkage in millimeter

    graft area ,thickness in millimeter

    2 weeks,month,3months

Secondary Outcomes (1)

  • success percentage

    3 months

Study Arms (1)

cyanoacrylate beside sutures for FGG fixation

EXPERIMENTAL

butyl cyanoacrylate

Drug: cyanoacrylate tissue adhesive beside sutures

Interventions

cyanoacrylate tissue adhesive beside suturesDRUG

using cyanoacrylate tissue adhesive for FGG fixation

Also known as: tissue adhesive
cyanoacrylate beside sutures for FGG fixation

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Tissue Adhesives

Intervention Hierarchy (Ancestors)

Biomedical and Dental MaterialsSpecialty Uses of ChemicalsChemical Actions and UsesSurgical Fixation DevicesSurgical EquipmentEquipment and SuppliesManufactured MaterialsTechnology, Industry, and Agriculture

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Cyanoacrylate beside sutures for Fixation of FGG
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
student

Study Record Dates

First Submitted

June 16, 2019

First Posted

August 21, 2019

Study Start

September 16, 2019

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

August 21, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share