Addition of Dehydrated Human Amnion-Chorion Membrane During Scaling and Root Planing

NCT03836378 | Active Not Recruiting

• 1 other identifier: 18-2447
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

Hypothesis: There will be an additional reduction of pocket depth and gain of clinical attachment when dehydrated human amnion-chorion membrane (dHACM) is placed into the periodontal disease defect after mechanical scaling and root planing. Specific Aim 1: to compare the clinical and radiographical outcome of using dehydrated human amnion-chorion membrane (dHACM) (commercially available as BioXclude®) with mechanical scaling and root planing.

Conditions

Periodontal Diseases

Keywords

Non-surgical periodontal therapy; Outcomes; Clinical trial; Periodontitis; Academic setting

Outcome Measures

Primary Outcomes (3)

• Pocket Depths

  Mean change in probing depths (using a UNC probe to measure probing depths).

  Month 9, Year 3, and Year 5

• Clinical Attachment Levels

  Mean change in attachment level (using a UNC probe to measure attachment levels).

  Month 9, Year 3, and Year 5

• Radiographic Alveolar Bone Gain

  Radiographic comparison from baseline radiograph to Month 9.

  Month 9, Year 3, and Year 5

Study Arms (2)

Deep Cleaning and Intervention

EXPERIMENTAL

One side of the participant's mouth will receive a deep cleaning in addition to the placement of a BioXclude™ membrane in the deep pocket sites. The participant will then be followed for 9 months with routine care.

Procedure: BioXclude™

Deep Cleaning Only

NO INTERVENTION

One side of the participant's mouth will receive deep cleaning (scaling and root planning) only. The participant will then be followed for 9 months with routine care.

Interventions

BioXclude™ PROCEDURE

The addition of BioXclude™ dehydrated human amnion-chorion membrane into deep pockets with scaling and root planing.

Deep Cleaning and Intervention

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stage III and IV periodontitis (generalized moderate to severe chronic periodontitis)
• At least 4 teeth (to include at least one qualifying tooth on the right and left side of the mouth) with probing depths of 6 to 9 millimeters and bleeding on probing
• at least 18 years of age
• consent to be in the study
• non-emergent dental treatment
• American Society of Anesthesiologists (ASA) Class I or II (prticipants that are systemically healthy or have a systemic condition that is well controlled and are able to receive elective dental care)

You may not qualify if:

• \<18 years old or \>100 years old
• currently pregnant or within 6 months postpartum, nursing
• require antibiotic prophylaxis prior to dental procedures as outlined by the 2017 American Heart Association guidelines
• decisionally challenged adults
• ASA Class III or IV (patients that have non-controlled systemic conditions that are unable to have elective dental care)
• had periodontal therapy within 6 months of baseline treatment visit
• antibiotic therapy within 3 months prior to enrollment
• chronic therapy within 1 month prior to enrollment with medications that could affect periodontal status or healing

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Sangeetha Chandrasekaran

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Periodontal Diseases; Periodontitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A random allocation will be completed (flip of coin) which side will receive the membrane placement. The care provider (hygienist) will be aware of the membrane placement. The investigator and outcome assessor (periodontist) will not know which sites received the membrane placement.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The participant will have half the mouth completed with scaling and root planing alone and half the mouth completed with scaling and root planing with the addition of membrane in deep probing depth sites.

Study Record Dates

• First Submitted: February 7, 2019
• First Posted: February 11, 2019
• Study Start: November 1, 2020
• Primary Completion: November 1, 2023
• Study Completion (Estimated): November 1, 2027
• Last Updated: April 5, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)