NCT03539939

Brief Summary

Cigarette smoking is a patient-related factor that can affect healing of periodontal tissues and the success rate of root-coverage procedures. Neither the nature nor the mechanisms of action of cigarette smoking on root coverage are fully understood. Therefore, the hypothesis that cigarette smoking has negative impacts on the outcomes of root coverage after CAF surgery in systemically healthy individuals with an initial gingival thickness of at least 0.8 mm and who practice optimal oral hygiene was tested. It was also hypothesized that baseline analysis of disease-related biomarkers would shed light on the underlying mechanisms of a possible effect.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2010

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 3, 2010

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2012

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2013

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

May 15, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 30, 2018

Completed
Last Updated

May 30, 2018

Status Verified

May 1, 2018

Enrollment Period

2.1 years

First QC Date

May 15, 2018

Last Update Submit

May 25, 2018

Conditions

Gingival RecessionSmoking

Keywords

Gingival crevicular fluidGingival recessionSalivaSmokingWound healing

Outcome Measures

Primary Outcomes (1)

  • Change in the percentage of root coverage

    Root coverage were measured on digital photographs using specific software.

    1-month, 3-month and 6-month after coronally advanced flap (CAF)

Secondary Outcomes (5)

  • Change in the percentage of complete root coverage

    1-month, 3-month and 6-month after coronally advanced flap (CAF)

  • Change in gingival thickness

    Baseline,1-month, 3-month and 6-month after coronally advanced flap (CAF)

  • Changing of the gingival crevicular fluid (GCF) biomarkers

    Baseline,1-month, 3-month and 6-month after coronally advanced flap (CAF)

  • Changing of the salivary biomarkers

    Baseline,1-month, 3-month and 6-month after coronally advanced flap (CAF)

  • Change in the visual analog scale (VAS) values

    1 to 7 day after coronally advanced flap (CAF)

Study Arms (2)

Smoker Group

EXPERIMENTAL

This group included smoker gingival recession patients.

Procedure: Coronally Advanced Flap

Non-smoker Group

ACTIVE COMPARATOR

This group included non-smoker gingival recession patients.

Procedure: Coronally Advanced Flap

Interventions

Coronally Advanced FlapPROCEDURE

The coronally advanced flap (CAF) is a procedure frequently used in periodontal plastic surgery. The main objective of this surgical technique is to mobilize the gingival margin and reposition it at a level more coronal (incisal direction) than its original location. CAF is mainly used for the treatment of gingival recessions.

Non-smoker GroupSmoker Group

Eligibility Criteria

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

You may qualify if:

  • Maxillary central and lateral incisors, canines, and premolars and mandibular premolars with isolated buccal recessions classified as Miller Class I or II
  • Study tooth should present tooth vitality, identifiable cemento-enamel junction (CEJ) and absence of caries, restorations or extensive non-carious cervical lesion.

You may not qualify if:

  • Medical disorders such as diabetes mellitus, immunologic disorders, hepatitis
  • History of previous mucogingival surgery at the gingival recession site
  • Medications known to affect gingival tissues
  • Antibiotic treatment in the past 6 months
  • Pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Gingival RecessionSmoking

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal AtrophyBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

May 15, 2018

First Posted

May 30, 2018

Study Start

May 3, 2010

Primary Completion

June 7, 2012

Study Completion

January 7, 2013

Last Updated

May 30, 2018

Record last verified: 2018-05