A Novel Volumetric Analysis Using CAD/CAM Scanners in Gingival Recession Treatment

NCT03295604 | Completed

• 1 other identifier: YuzuncuYıl 3
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

Brief Summary

Aim: In this ramdomised clinical trial (RCT), the aim was to compare clinical periodontal data of subepithelial connective tissue graft (SCTG) group and SCGT+enamel matrix derivatives (EMD) group in terms of gained gingiva volume (GGV) and gained gingiva surface area (GGSA) by scanners of computer-aided design/computer-aided manufacturing (CAD/CAM) devices. Materials and Methods: A total of 35 Miller class I-II gingival recession defects were involved in this study (n=17 in SCTG group, n=18 in SCTG+EMD group). In addition to periodontal clinical parameters, three dimensional (3D) images were recorded using CAD/CAM system before the treatment, at the 1st month and at the 6th months after the treatment. The images were superimposed using softwares and GGV, GGSA were calculated.

Conditions

Gingival Recession

Keywords

Gingival recession; Subepithelial connective tissue grafts; CAD/CAM

Outcome Measures

Primary Outcomes (4)

• GGV

  Gingival gain volume: measured by software on images (mm3)

  6 months

• GGSA

  Gingival gain of surface area: measured by software on images (mm2

  6 months

• GRH

  gingival recession height: the distance between cementoenamel junction to gingival margin (mm)

  6 months

• GRW

  gingival recession width: the distance between mesial and distal gingival margins (mm)

  6 months

Study Arms (2)

test group

EXPERIMENTAL

Miller class I-II gingival recession defects operated with sub epithelial connective tissue graft (SCTG) in addition with enamel matrix derivatives (EMD) (Emdogain ®, Switzerland ) in SCTG+EMD group.

Procedure: SCTG+EMD

control group

EXPERIMENTAL

Miller class I-II gingival recession defects operated with only sub epithelial connective tissue graft (SCTG). No drug or something else were used

Procedure: SCTG

Interventions

SCTG+EMD PROCEDURE

Miller class I-II gingival recession defects were operated with SCTG+EMD

test group

SCTG PROCEDURE

Miller class I-II gingival recession defects were operated with SCTG only and

control group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• individuals should have no systemic disease
• non-smokers of cigarette or tobacco products
• not in a pregnancy,
• have not used any antibiotics or medications with an impact on the immune system within last 6 months,
• have GR classified as Miller class I or class II
• have GR depth of ≥2mm ,
• have no decay or restoration on the vital teeth which will be operated
• have no operation history with regard to GRs for related tooth area.

You may not qualify if:

• pregnancy
• smoking
• Miller class III and IV gingival recession
• antibiotic use

Sponsors & Collaborators

• Hacer Sahin Aydinyurt: lead
• Yuzuncu Yil University: collaborator

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: August 16, 2017
• First Posted: September 28, 2017
• Study Start: April 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2014
• Last Updated: September 28, 2017

Record last verified: 2017-09