NCT01538927

Brief Summary

The aim of this randomized controlled clinical trial is to compare wound healing after the use of fibrin sealant and sutures for gum surgeries. 15 patients requiring gum surgery for their periodontal (gum)problems are selected and invited. Two regions will be operated in a selected patient. One region will receive fibrin sealant (test site) and the other region will get sutures (control site). Wound healing will be assessed by evaluating inflammatory markers, Interleukin 1beta and interleukin 8, from a non invasively collected gum fluid. Hypothesis. Fibrin sealant use will result in less inflammation seen through reduced levels of interleukin (1beta and 8) compared to use of sutures.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2012

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

February 10, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 24, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

December 25, 2012

Status Verified

December 1, 2012

Enrollment Period

8 months

First QC Date

February 10, 2012

Last Update Submit

December 22, 2012

Conditions

Periodontitis

Keywords

fibrin sealanttissue adhesivewound healinginterleukin 1 betainterleukin 8

Outcome Measures

Primary Outcomes (1)

  • Concentration of cytokines.

    Assess the concentration of Interleukin 1beta and Interleukin 8 in GCF of test and control sites after 7 days.

    7 days

Secondary Outcomes (1)

  • Clinical inflammation

    7, 14 and 21 days

Study Arms (2)

Fibrin Sealant

EXPERIMENTAL

One quadrant surgically elevated will be closed with fibrin sealant

Drug: Fibrin Sealant

Suture

PLACEBO COMPARATOR

The surgically elevated flap is closed with non resorbable sutures.

Drug: Suture

Interventions

Fibrin SealantDRUG

Fibrin Sealant 4ml (Baxter Tisseel)

Also known as: TISSEEL™ Kit, Two component Fibrin Sealant, Steam - treated
Fibrin Sealant
SutureDRUG

Black silk 000

Also known as: Ethicon
Suture

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • A subject has to be between the ages of 18 and 60 years.
  • Severe Periodontitis: Presence of a jaw with each quadrant having atleast 4 teeth with a probing depth of ≥ 6mm and is indicated for periodontal flap surgery.
  • Compliance: Only patients with optimal compliance, as assessed during the cause-related phase of therapy, are selected.
  • Good oral hygiene: Full-mouth plaque score (FMPS) \< 25%.
  • Low levels of residual infection: Full-mouth bleeding score (FMBS) \< 25%.
  • Endodontic status: Teeth had to be vital or properly treated with root canal therapy

You may not qualify if:

  • History of any systemic disease such as diabetes mellitus, osteoporosis, unstable or life-threatening conditions, bleeding disorder, undergoing antibiotic or other antimicrobial therapy.
  • Current or former smokers.
  • Had undergone periodontal therapy in the past 6 months, or exhibit poor plaque control after phase I therapy.
  • Mobility of selected teeth.
  • Pregnant or lactating women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chhattisgarh Dental College and Research Institute

Rāj-Nāndgaon, Chhattisgarh, 491441, India

Location

MeSH Terms

Conditions

Periodontitis

Interventions

Fibrin Tissue AdhesiveSutures

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

FibrinBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSurgical Fixation DevicesSurgical EquipmentEquipment and Supplies

Study Officials

  • Shaju P Jacob, MDS

    Chhattisgarh Dental College and Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 10, 2012

First Posted

February 24, 2012

Study Start

April 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

December 25, 2012

Record last verified: 2012-12

Locations

IN(1)