An Explorative Study To Develop A Predictive Model Based... | NCT02210143

Studies
An Explorative Study To Develop A Predictive Model Based On Avascular Exposed Root Surface Area For Root Coverage

NCT02210143

Sponsor

Cukurova University

Status

Completed

Last Update Posted

Aug 6, 2014Estimated

Enrollment

91Actual

Phase

Not provided

Conditions

Gingival Recession

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2011

Primary Completion Date

Mar 2013Actual

Completion Date

Not provided

First Submitted Date

Aug 5, 2014

First Submission Date that Met QC Criteria

Aug 5, 2014

First Posted Date

Aug 6, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 5, 2014

Last Update Posted Date

Aug 6, 2014Estimated

Description Module

Brief Summary

The aim of this study was to evaluate the reliability of the avascular root surface area as a prognostic identification criterion for gingival recessions and to compare the predictive value of the Miller classification and avascular root surface area (AERSA) calculation on the final root coverage outcomes.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

91Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AERSA-I gingival recession		The AERSA classification was developed based on 15 mm2 which is the lowest cut-off point and the group of AERSA ≤ 15 mm2 named as AERSA-I (low risk group)
AERSA-II gingival recession		AERSA > 15 mm2 named as AERSA-II (high risk group).
Miller gingival recession		Gingival recessions classified according to Miller

Interventions

Not provided

Measure	Description	Time Frame
Complete root coverage		6 months

Measure	Description	Time Frame
mean root coverage		6 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Presence of isolated Miller I, II or III recession, (Miller 1985a)
Presence of identifiable cementoenamel junction (CEJ); presence of a step ≤ 2mm at CEJ level and/or the presence of a root abrasion, but with an identifiable CEJ,
Full-mouth plaque score and Full-mouth bleeding score of < 15% (four sites/tooth),
No occlusal interferences;
Non-smokers

Exclusion Criteria:

Tooth with a prosthetic restoration involving CEJ,
Patients with a history of periodontitis or abscess formation,
Presence of systemic disease or taking medications known to interfere with periodontal tissue health
Pregnant or nursing patients

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

41 Years

Standard Ages

Adult

Study Population

Ninety one patients, 41 females and 50 males, aged between 21-41 years, with 91 isolated single gingival recessions (32 Miller I, 29 Miller II, 30 Miller III defects) located at upper and lower incisors and canines.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cukurova University Ethics Comitee		Adana	Balcali	01130	Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D005889	Gingival Recession

Ancestor Terms

ID	Term
D005882	Gingival Diseases
D010510	Periodontal Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided