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Comparison of Coronally Advanced Root Coverage Procedure With Collagen Matrix and Connective Tissue Graft

Primary Purpose

Gingival Recession

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Ossix volumax collagen matrix
Connective Tissue Graft
Sponsored by
Krishnadevaraya College of Dental Sciences & Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession focused on measuring Gingival Recession Coverage

Eligibility Criteria

18 Years - 58 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age greater than or equal to18 years.
  • Multiple adjacent Miller's class I and class II gingival recession sites.
  • Patients with healthy or treated periodontal conditions.
  • Patients with esthetic concerns.
  • Absence of uncontrolled medical conditions.
  • Full mouth plaque score </= 10% (O'Leary 1972)
  • Full mouth bleeding score <10% (Ainamo and Bay 1975)

Exclusion Criteria:

  • Gingival biotype less than 0.8 mm.
  • Pregnant or lactating females.
  • Tobacco smoking.
  • Untreated periodontal conditions.
  • Use of systemic antibiotics in the past 3 months.
  • Patients treated with any medication known to cause gingival hyperplasia

Sites / Locations

  • Krishnadevaraya college of dental sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Root coverage with ossix volumax collagen matrix

Root coverage with connective tissue graft

Arm Description

Evaluation of root coverage achieved by collagen matrix in conjunction with coronally advanced flap in patients with multiple gingival recession.

Evaluation of root coverage achieved by connective tissue graft in conjunction with coronally advanced flap in patients with multiple gingival recession

Outcomes

Primary Outcome Measures

gingival recession depth
measured as the distance from the CEJ to the gingival margin.
Complete root coverage
root coverage regarded as complete with gingival margin located at the level of Cemento Enamel Junction
Mean root coverage
(Baseline recession depth - 6 month recession depth/Baseline recession depth)*100

Secondary Outcome Measures

pocket Probing depth
measured as the distance from the gingival margin to the base of gingival sulcus
Gingival Recession width
measured as the distance between the mesial gingival margin and distal gingival margin (measurement will be recorded on a horizontal line tangential to the cementoenamel junction).
Clinical attachment level
measured as Gingival Recession Depth + Probing Depth
Gingival biotype thickness
measured 3mm apically from the free gingival margin at the mid buccal aspect of the tooth.
Apico-coronal width of keratinized tissue
) measured as the distance from the mucogingival junction to the gingival margin,with the mucogingival junction location determined using (Schiller's Potassium Iodide Solution).
Root coverage esthetic score
The Aesthetic evaluation was performed according to the root coverage aesthetic score system (RES). Five Variables evaluated which are as follows: Level of Gingival margin (GM) Marginal Tissue Contour (MTC) Soft Tissue Texture (STT) Mucogingival Junction(MJ) alignment Gingival Colour (GC) The values ranges between 0 - 6.Higher the value better is the outcome.
Plaque index
It is measured by using UNC 15 probe.The values lie between 0 - 3.Higher the outcome the prognosis will be poor.
Gingival index
It is measured by using UNC 15 probe.The values lie between 0 - 3.Higher the outcome the prognosis will be poor.
Gingival Bleeding index
It is measured by using UNC 15 probe.The values lie between 0 - 1. And presence or absence of bleeding is evaluated.

Full Information

First Posted
December 10, 2019
Last Updated
March 24, 2023
Sponsor
Krishnadevaraya College of Dental Sciences & Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04195737
Brief Title
Comparison of Coronally Advanced Root Coverage Procedure With Collagen Matrix and Connective Tissue Graft
Official Title
Comparative Evaluation of Coronally Advanced Root Coverage Procedure With Ossix Volumax™ Collagen Matrix and Connective Tissue Graft-Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
December 12, 2019 (Actual)
Primary Completion Date
July 17, 2021 (Actual)
Study Completion Date
August 6, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Krishnadevaraya College of Dental Sciences & Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The present study is a human, prospective, randomised controlled clinical trial conducted to explore the outcome of a coronally advanced flap with ossix volumaxTM collagen matrix and connective tissue graft in the treatment of multiple adjacent gingival recession defects. The trial is in accordance with the Consolidated Standards of Reporting Trials (CONSORT) criteria, 2010.
Detailed Description
Periodontal plastic surgery are surgical procedures performed to prevent or correct anatomic, developmental, traumatic or disease-induced defects of the gingiva, alveolar mucosa or bone. It includes various soft and hard tissue procedures aimed at gingival augmentation, root coverage, correction of mucosal defects at implants, crown lengthening, gingival preservation at ectopic tooth eruption, removal of aberrant frena, prevention of ridge collapse associated with tooth extraction and augmentation of the edentulous ridge.1 Different predisposing anatomic features can result in recession such as position and anatomy of teeth in the dental arch, bony dehiscence, thickness of the alveolar mucosa, muscle pull, orthodontic treatment, thin gingival biotype, buccal prominence of teeth, lack of keratinized tissue, abnormal frenum attachment, or patient related factors such as vigorous brushing or chronic gingival inflammation.2 The migration of the marginal tissue to an apical position may lead to esthetic concern, dentin hypersensitivity, root caries, and cervical wear. Treatment modalities for gingival recession have many influencing factors such as defect dimensions (depth, width), site (maxilla, mandible), defect number (single, multiple), soft tissue anatomy (keratinized tissue quality/quantity; papilla height/width; frenum/ muscle pull; vestibular depth) tooth position etc. Various surgical techniques for the treatment of recessions includes the use of full or partial thickness flap with various soft tissue grafts such as epithelized free gingival grafts (FGG) or sub-epithelial connective tissue graft (SCTG) in conjunction with various types of flaps eg: (envelope, coronally or laterally positioned flap, double pedicle flap (DPF) or tunnelling (TUN) alone or combined with laterally positioned pedicle flaps (LPPF).3 Coronally advanced flap (CAF) with connective tissue graft (CTG) is considered as the gold standard treatment for gingival recession. Commercially available materials for root coverage are expanded Poly Tetra Fluoro Ethylene (Gore-Tex), polglactin, Collagen membranes like biogide, biomend, resolute, alloderm, collatape etc, collagen matrix such as mucograft, human amniotic membrane, dermagraft, ossix.4 Recently in a case report using platelet concentrate carried on collagen sponge (ossix) showed favourable results.4 Ossix volumax™ has shown De novo bone formation when used in alveolar ridge augmentation procedure.5 Ossix volumax™ (Datum dental) is one such recently identified sugar cross-linked bio programmed collagen matrix. Ossix volumax™ is a volumizing, thick collagen scaffold, featuring glymatrix technology. The properties are thick and expand when wet, excellent handling, easy to use, adapts and adheres to the bone.5 It undergoes rapid ossification (in CT scans and histology after one month).6 Literature search till date has shown no studies regarding the use of type 1 sugar cross-linked collagen membrane for treatment of gingival recession. So, the present study is undertaken with the aim to comparatively evaluate the advantages of ossix volumax collagen membrane with subepithelial connective tissue graft for the treatment of multiple adjacent gingival recession defects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Recession
Keywords
Gingival Recession Coverage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups were made one test and control. The test group will be treated with coronally advanced flap with ossix volumax™ collagen matrix and control group will be treated with coronally advanced flap with Sub epitheial Connective Tissue Graft.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Root coverage with ossix volumax collagen matrix
Arm Type
Experimental
Arm Description
Evaluation of root coverage achieved by collagen matrix in conjunction with coronally advanced flap in patients with multiple gingival recession.
Arm Title
Root coverage with connective tissue graft
Arm Type
Active Comparator
Arm Description
Evaluation of root coverage achieved by connective tissue graft in conjunction with coronally advanced flap in patients with multiple gingival recession
Intervention Type
Procedure
Intervention Name(s)
Ossix volumax collagen matrix
Intervention Description
Under LA horizontal incision is made.Split-full-split thickness flap is elevated.The remaining soft tissue of the anatomic interdental papillae deepithelialized.Coronal advancement of the flap obtained and closed using sling suture.
Intervention Type
Procedure
Intervention Name(s)
Connective Tissue Graft
Intervention Description
Under LA parallel incisions is made 1-2 mm first molar to canine.Graft incision 1 mm coronal to the horizontal flap incision.Through this incision designed graft thickness is obtained.The graft obtained between the two horizontal incisions has a 1 mm coronal strip that require depithelisation with a knife and closed using interrupted suture.
Primary Outcome Measure Information:
Title
gingival recession depth
Description
measured as the distance from the CEJ to the gingival margin.
Time Frame
6 months
Title
Complete root coverage
Description
root coverage regarded as complete with gingival margin located at the level of Cemento Enamel Junction
Time Frame
6 months
Title
Mean root coverage
Description
(Baseline recession depth - 6 month recession depth/Baseline recession depth)*100
Time Frame
6 months
Secondary Outcome Measure Information:
Title
pocket Probing depth
Description
measured as the distance from the gingival margin to the base of gingival sulcus
Time Frame
6 months
Title
Gingival Recession width
Description
measured as the distance between the mesial gingival margin and distal gingival margin (measurement will be recorded on a horizontal line tangential to the cementoenamel junction).
Time Frame
6 months
Title
Clinical attachment level
Description
measured as Gingival Recession Depth + Probing Depth
Time Frame
6 months
Title
Gingival biotype thickness
Description
measured 3mm apically from the free gingival margin at the mid buccal aspect of the tooth.
Time Frame
6 months
Title
Apico-coronal width of keratinized tissue
Description
) measured as the distance from the mucogingival junction to the gingival margin,with the mucogingival junction location determined using (Schiller's Potassium Iodide Solution).
Time Frame
6 months
Title
Root coverage esthetic score
Description
The Aesthetic evaluation was performed according to the root coverage aesthetic score system (RES). Five Variables evaluated which are as follows: Level of Gingival margin (GM) Marginal Tissue Contour (MTC) Soft Tissue Texture (STT) Mucogingival Junction(MJ) alignment Gingival Colour (GC) The values ranges between 0 - 6.Higher the value better is the outcome.
Time Frame
6 months
Title
Plaque index
Description
It is measured by using UNC 15 probe.The values lie between 0 - 3.Higher the outcome the prognosis will be poor.
Time Frame
6 months
Title
Gingival index
Description
It is measured by using UNC 15 probe.The values lie between 0 - 3.Higher the outcome the prognosis will be poor.
Time Frame
6 months
Title
Gingival Bleeding index
Description
It is measured by using UNC 15 probe.The values lie between 0 - 1. And presence or absence of bleeding is evaluated.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
58 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age greater than or equal to18 years. Multiple adjacent Miller's class I and class II gingival recession sites. Patients with healthy or treated periodontal conditions. Patients with esthetic concerns. Absence of uncontrolled medical conditions. Full mouth plaque score </= 10% (O'Leary 1972) Full mouth bleeding score <10% (Ainamo and Bay 1975) Exclusion Criteria: Gingival biotype less than 0.8 mm. Pregnant or lactating females. Tobacco smoking. Untreated periodontal conditions. Use of systemic antibiotics in the past 3 months. Patients treated with any medication known to cause gingival hyperplasia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prabhuji MLV
Organizational Affiliation
Krishnadevarya Dental College
Official's Role
Study Director
Facility Information:
Facility Name
Krishnadevaraya college of dental sciences
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
562157
Country
India

12. IPD Sharing Statement

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Comparison of Coronally Advanced Root Coverage Procedure With Collagen Matrix and Connective Tissue Graft

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