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A Clinical Trial Testing Root Coverage With Acellular Dermal Matrix in Thin and Thick Gingival Biotypes

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ClinicalTrials.gov Identifier: NCT03057730
Recruitment Status : Recruiting
First Posted : February 20, 2017
Last Update Posted : May 16, 2018
Sponsor:
Information provided by (Responsible Party):
Tufts University School of Dental Medicine

Brief Summary:

Gingival recession is a common defect among the American population. It is also a major cause for root decay, hypersensitivity, contributes to tooth mobility and low self-esteem. Acellular dermal matrix, a human-derived grafting material has been put on the market for the treatment of gingival recession. Treating gingival recession with this material has been a validated treatment option for years.

However, treatment outcomes in two patient populations, namely those with thin biotypes and those with thick biotypes, has not been investigated. This study will observe the primary treatment outcomes in the two patient groups at 5 time points - 3 months, 6 months and 12 months post-surgery to observe short term outcomes; additional 24 months and 48 months post-surgery to observe long term outcomes.


Condition or disease Intervention/treatment Phase
Gingival Recession Biological: Acellular Dermal Matrix Phase 4

Detailed Description:

The study aim is to evaluate and compare the use of acellular dermal matrix, a material used for treating gum recession, in two study populations, namely thin or thick gingival biotype. Short term outcomes and the long term stability of ADM in recession repair between thick and thin biotypes will be evaluated.

There will be two study groups, namely thin and thick groups. The included subjects will be divided in two groups according to gingival thickness: Thin gingival biotype group (TnB): < 0.8 mm, thick gingival biotype group (TkB) ≥ 0.8 mm. Each subject will be in one of the two groups only.

Randomization will not be used to assign the subjects to the study groups, because the intervention will be the same for both groups, namely ADM applied beneath a coronally advanced flap.

The short term (3 months, 6 months post-surgery) outcomes and the longer term (12 months, 24 months and 48 months post-surgery) outcomes will further be compared within the groups and between the groups.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acellular Dermal Matrix Combined With Coronally Advanced Flap in the Treatment of Multiple Recession Defects in Thin Versus Thick Periodontal Biotype Population: A Controlled Clinical Investigation
Actual Study Start Date : August 2015
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : August 2021

Arm Intervention/treatment
Experimental: Group 1: Thin Biotype

Gingival thickness < 0.8 mm

Acellular Dermal Matrix (ADM) will be used according to manufacturer's instructions during mucogingival surgery. Subjects will be anesthetized using local anesthesia. An envelope flap design will be involved with no releasing incisions. The ADM will be placed beneath the flap. The flap will then be advanced to the level of cemento-enamel junction (CEJ). The area will be sutured.

Mean root coverage, CPD, CAL, RH, RW, KTW, GT, and CRC will be measured and compared at 3 months, 6 months, 12 months, 24 months and 48 months post-surgery.

Biological: Acellular Dermal Matrix
ADM is a human-derived allograft material, treated to remove all cellular components so that only the connective tissue matrix remains.
Other Name: Alloderm®

Experimental: Group 2: Thick Biotype

Gingival thickness ≥ 0.8 mm

Acellular Dermal Matrix (ADM) will be used according to manufacturer's instructions during mucogingival surgery. Subjects will be anesthetized using local anesthesia. An envelope flap design will be involved with no releasing incisions. The ADM will be placed beneath the flap. The flap will then be advanced to the level of cemento-enamel junction (CEJ). The area will be sutured.

Mean root coverage, CPD, CAL, RH, RW, KTW, GT, and CRC will be measured and compared at 3 months, 6 months, 12 months, 24 months and 48 months post-surgery.

Biological: Acellular Dermal Matrix
ADM is a human-derived allograft material, treated to remove all cellular components so that only the connective tissue matrix remains.
Other Name: Alloderm®




Primary Outcome Measures :
  1. Change in Mean Root Coverage [ Time Frame: Up to 48 months post surgery ]
    Root coverage will be measured in mm using a probe and digital caliper. Mean root coverage will be measured per patient by averaging the two study teeth. Change in mean root coverage for the primary outcome will be assessed by the difference between the baseline mean root coverage and the final mean root coverage at 48 months post surgery.


Secondary Outcome Measures :
  1. Change in Clinical Probing Depth (CPD) [ Time Frame: Up to 48 months post surgery ]
  2. Change in Clinical Attachment Level (CAL) [ Time Frame: Up to 48 months post surgery ]
    CAL will be measured from the base of the pocket to the cementoenamel junction (CEJ) in mm using a probe and digital caliper. Change in CAL will be assessed from baseline to 48 months post surgery.

  3. Change in Recession Height (RH) [ Time Frame: Up to 48 months post surgery ]
  4. Change in Recession Width (RW) [ Time Frame: Up to 48 months post surgery ]
  5. Change in Keratinized Tissue Width [ Time Frame: Up to 48 months post surgery ]
  6. Change in Gingival Thickness (GT) [ Time Frame: Up to 48 months post surgery ]
  7. Complete Root Coverage (CRC) [ Time Frame: Up to 48 months post surgery ]
    CRC will be assessed using descriptive statistics (# subjects with CRC out of the total sample)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects must be current patients of Tufts University School of Dental Medicine
  • Subjects with two Miller class I or class II adjacent recessions with a recession height ≥ 2 mm and < 4 mm
  • Affected tooth/teeth are anterior- incisors, canines or premolars (except the mandibular central and lateral incisors)
  • Healthy subjects with no contraindications to root coverage surgery
  • Subjects with full-mouth plaque index<1 and gingival index<1, calculated as the average value of plaque index and gingival index

Exclusion Criteria:

  • Presence of adjacent defects, whose gingival thickness values place them in a different category other than thick or thin biotype
  • Areas that have previously been treated with root coverage surgeries
  • Subjects with a known hypersensitivity to polysorbate 20 (contraindicated with the use of Alloderm®)
  • Subject smokes more than 5 cigarettes per day
  • Subjects with systemic conditions which influence wound healing
  • Subjects that are pregnant or lactating
  • Subjects with a condition causing immunosuppression, or currently taking immunosuppressant medications
  • Teeth with severe occlusal interferences, deep cervical lesions, or large restorations whose margins impinge on the cement-enamel junction or make identification of this landmark impossible

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03057730


Contacts
Contact: Amanda Gozzi, MS Amanda.Gozzi@tufts.edu

Locations
United States, Massachusetts
Tufts University School of Dental Medicine Recruiting
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts University School of Dental Medicine
Investigators
Principal Investigator: Wai Cheung, DMD, MS Tufts University School of Dental Medicine

Responsible Party: Tufts University School of Dental Medicine
ClinicalTrials.gov Identifier: NCT03057730     History of Changes
Other Study ID Numbers: 11692
First Posted: February 20, 2017    Key Record Dates
Last Update Posted: May 16, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Tufts University School of Dental Medicine:
acellular dermal matrix

Additional relevant MeSH terms:
Gingival Recession
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Periodontal Atrophy