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

NCT03057730 | Active Not Recruiting Phase 4

• 1 other identifier: 11692
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingival Recession

Keywords

acellular dermal matrix

Outcome Measures

Primary Outcomes (1)

• Change in Mean Root Coverage

  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.

  Up to 48 months post surgery

Secondary Outcomes (7)

• Change in Clinical Probing Depth (CPD)

  Up to 48 months post surgery

• Change in Clinical Attachment Level (CAL)

  Up to 48 months post surgery

• Change in Recession Height (RH)

  Up to 48 months post surgery

• Change in Recession Width (RW)

  Up to 48 months post surgery

• Change in Keratinized Tissue Width

  Up to 48 months post surgery

Study Arms (2)

Group 1: Thin Biotype

EXPERIMENTAL

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

Group 2: Thick Biotype

EXPERIMENTAL

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

Interventions

Acellular Dermal Matrix BIOLOGICAL

ADM is a human-derived allograft material, treated to remove all cellular components so that only the connective tissue matrix remains.

Also known as: Alloderm®

Group 1: Thin Biotype; Group 2: Thick Biotype

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tufts University: lead

Study Sites (1)

Tufts University School of Dental Medicine

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Gingival Recession

Interventions

Alloderm

Condition Hierarchy (Ancestors)

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

Study Officials

• Wai Cheung, DMD, MS

  Tufts University School of Dental Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2017
• First Posted: February 20, 2017
• Study Start: August 1, 2015
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: August 20, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)