NCT03659344

Brief Summary

Patients randomly aligned in 2 groups.Vicryl plus sutures were used in group 1 for closing subperiostal flaps after dental implant surgeries and vicryl sutures were used in group 2.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
320

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 31, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 6, 2018

Completed
Last Updated

September 6, 2018

Status Verified

September 1, 2018

Enrollment Period

1.4 years

First QC Date

August 31, 2018

Last Update Submit

September 3, 2018

Conditions

Infection, Surgical Site

Keywords

suturesSurgical Wound InfectionPolyglactin 910

Outcome Measures

Primary Outcomes (2)

  • The prevalence of post-operative infection

    The number of participants who had local erythematous change in the sutured wound with purulent discharge or localized abscess formation on surgical site.

    In one month

  • The prevalence of post-operative dehiscence

    The number of participants who had relatively or completely open wound

    In one month

Study Arms (2)

Vicryl plus

ACTIVE COMPARATOR

In this group, vicryl plus(Triclosan coated) sutures were used to close flaps

Drug: Vicryl plus

vicryl

NO INTERVENTION

In this group, vicryl sutures were used to close flaps

Interventions

Vicryl plusDRUG

Using vicryl sutures which coated with triclosan (antibiotic)

Vicryl plus

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Need 3 dental implants at the posterior of the mandible

You may not qualify if:

  • Diabetic patients
  • smoker
  • poor oral hygiene

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Polyglactin 910

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PolyestersPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Patients were blind about kind of sutures which were used to close flaps.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: In group1, vicryl plus suture was used to close flaps. In group2,vicryl was used to close flaps
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor of OMFS

Study Record Dates

First Submitted

August 31, 2018

First Posted

September 6, 2018

Study Start

September 1, 2016

Primary Completion

February 1, 2018

Study Completion

July 30, 2018

Last Updated

September 6, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share