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A Pilot Study of CelTx(TM) (Apligraf®) in the Treatment of Gingival Recession Requiring Root Coverage

Primary Purpose

Gingival Recession

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CelTx
Autologous sub-epithelial connective tissue graft
Sponsored by
Organogenesis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject is at least 18 years of age but no more than 70 years of age.
  • Subject has at least two non-adjacent teeth in contralateral quadrants of the same jaw with Miller Class I or II buccal recession (≥ 3 mm) that requires soft tissue grafting. (Teeth may be treated with a maximum difference of 2 mm with respect to depth and width).
  • Females of childbearing potential must have a documented negative urine pregnancy test and must agree to continue acceptable methods of contraception for 6 months post surgery.
  • Subjects must have read, understood and signed an institutional review board (IRB)-approved Informed Consent Form (ICF).
  • Subjects must be able and willing to follow study procedures and instructions.

Exclusion Criteria:

  • Subject has extremely prominent root surfaces (> 1/2 the diameter of the root facial to cortical plate).
  • Subject has interproximal attachment loss beyond the CEJ.
  • Subject with teeth that have a Miller Grade 2 or higher mobility.
  • Subjects with Class V restorations.
  • Subjects with crowns on the teeth selected for treatment.
  • Subjects who have had endodontic therapy in the last 6 months on the teeth selected for treatment.
  • Subjects who have used any tobacco product within the past 3 months.
  • Subjects with only molar teeth suitable for soft tissue grafting.
  • Subject has probing pocket depth >/= 4 mm at either surgical site.
  • Female subjects who are pregnant or lactating.
  • Subjects with any systemic conditions (i.e., uncontrolled diabetes mellitus, cancer, HIV, bone metabolic diseases) that could compromise wound healing and preclude periodontal surgery.
  • Subjects who are currently receiving or have received within two months prior to study entry, systemic corticosteroids, immunosuppressive agents, radiation therapy, and/or chemotherapy which could compromise wound healing and preclude periodontal surgery.
  • Subjects with the presence of acute infectious lesions.
  • Subjects taking intramuscular or intravenous bisphosphonates.
  • Subjects with a known hypersensitivity to bovine collagen and/or iodine (shellfish allergy).
  • Subjects who have received an investigational drug, device or biological/bioactive treatment within 30 days prior to study enrollment (medical or dental).
  • Subjects previously treated with Apligraf/CelTx, Dermagraft or any other cell-based product, including autologous tissue at the target site(s) or immediately adjacent teeth.
  • Subjects, who in the opinion of the investigator, for any reason other than those listed above, will not be able to complete the study per protocol

Sites / Locations

  • Perio Health Professionals, PLLC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CelTx

Autologous CTG

Arm Description

CelTx

Autologous sub-epithelial connective tissue graft

Outcomes

Primary Outcome Measures

Overall Rate of Adverse Events (AEs)
Adverse events were collected at every visit throughout the 6 month duration. An AE is defined as any adverse change in the subject's medical status when compared with the subject's baseline condition, whether or not the event is related to the study device or a study procedure; or an exacerbation (either in frequency or severity) in a subject's pre-existing condition.

Secondary Outcome Measures

Periodontal Health Measures
Aesthetic Measures
Post-Surgical Subject Comfort Measures
Subject Preference Measures

Full Information

First Posted
May 14, 2008
Last Updated
January 9, 2012
Sponsor
Organogenesis
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1. Study Identification

Unique Protocol Identification Number
NCT00679081
Brief Title
A Pilot Study of CelTx(TM) (Apligraf®) in the Treatment of Gingival Recession Requiring Root Coverage
Official Title
A Prospective, Randomized, Controlled Pilot Study of CelTx(TM) (Apligraf®) as an Alternative to Tissue From the Palate in the Treatment of Gingival Recession Requiring Root Coverage
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Terminated
Study Start Date
May 2008 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organogenesis

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate CelTx as an alternative to tissue from the palate in the treatment of subjects with Miller Class I or II recession defects who desire root coverage. It is anticipated that this study will demonstrate that CelTx is a safe alternative to palatal tissue and demonstrate potential to enhance oral soft tissue regeneration and wound healing.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CelTx
Arm Type
Experimental
Arm Description
CelTx
Arm Title
Autologous CTG
Arm Type
Active Comparator
Arm Description
Autologous sub-epithelial connective tissue graft
Intervention Type
Device
Intervention Name(s)
CelTx
Intervention Description
Single application; split-mouth design
Intervention Type
Other
Intervention Name(s)
Autologous sub-epithelial connective tissue graft
Intervention Description
Single application; split-mouth design
Primary Outcome Measure Information:
Title
Overall Rate of Adverse Events (AEs)
Description
Adverse events were collected at every visit throughout the 6 month duration. An AE is defined as any adverse change in the subject's medical status when compared with the subject's baseline condition, whether or not the event is related to the study device or a study procedure; or an exacerbation (either in frequency or severity) in a subject's pre-existing condition.
Time Frame
6-month
Secondary Outcome Measure Information:
Title
Periodontal Health Measures
Time Frame
6-months
Title
Aesthetic Measures
Time Frame
6-months
Title
Post-Surgical Subject Comfort Measures
Time Frame
4-weeks
Title
Subject Preference Measures
Time Frame
6-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject is at least 18 years of age but no more than 70 years of age. Subject has at least two non-adjacent teeth in contralateral quadrants of the same jaw with Miller Class I or II buccal recession (≥ 3 mm) that requires soft tissue grafting. (Teeth may be treated with a maximum difference of 2 mm with respect to depth and width). Females of childbearing potential must have a documented negative urine pregnancy test and must agree to continue acceptable methods of contraception for 6 months post surgery. Subjects must have read, understood and signed an institutional review board (IRB)-approved Informed Consent Form (ICF). Subjects must be able and willing to follow study procedures and instructions. Exclusion Criteria: Subject has extremely prominent root surfaces (> 1/2 the diameter of the root facial to cortical plate). Subject has interproximal attachment loss beyond the CEJ. Subject with teeth that have a Miller Grade 2 or higher mobility. Subjects with Class V restorations. Subjects with crowns on the teeth selected for treatment. Subjects who have had endodontic therapy in the last 6 months on the teeth selected for treatment. Subjects who have used any tobacco product within the past 3 months. Subjects with only molar teeth suitable for soft tissue grafting. Subject has probing pocket depth >/= 4 mm at either surgical site. Female subjects who are pregnant or lactating. Subjects with any systemic conditions (i.e., uncontrolled diabetes mellitus, cancer, HIV, bone metabolic diseases) that could compromise wound healing and preclude periodontal surgery. Subjects who are currently receiving or have received within two months prior to study entry, systemic corticosteroids, immunosuppressive agents, radiation therapy, and/or chemotherapy which could compromise wound healing and preclude periodontal surgery. Subjects with the presence of acute infectious lesions. Subjects taking intramuscular or intravenous bisphosphonates. Subjects with a known hypersensitivity to bovine collagen and/or iodine (shellfish allergy). Subjects who have received an investigational drug, device or biological/bioactive treatment within 30 days prior to study enrollment (medical or dental). Subjects previously treated with Apligraf/CelTx, Dermagraft or any other cell-based product, including autologous tissue at the target site(s) or immediately adjacent teeth. Subjects, who in the opinion of the investigator, for any reason other than those listed above, will not be able to complete the study per protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael McGuire, DDS
Organizational Affiliation
Perio Health Professionals, PLLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Perio Health Professionals, PLLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77063
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Pilot Study of CelTx(TM) (Apligraf®) in the Treatment of Gingival Recession Requiring Root Coverage

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