Palatal Volumetric Change Analysis Following Connective Tissue Graft With and Without Donor Site Augmentation

January 17, 2024 updated by: Hailey Bivens

Palate Volumetric Change Analysis Following Connective Tissue Graft Harvesting With and Without Donor Site Augmentation: Randomized Controlled Trial

The goal of this randomized clinical trial is to compare whether soft tissue augmentation placed in the donor site following a gum graft harvesting leads to volumetric changes compared to non-augmented sites in the palate. The main questions it aims to answer are:

  • Are there tissue thickness changes between the two groups (control group and augmentation group)?
  • Are there volumetric changes in the donor site (palate) between the two groups in the short and long term? Participants will receive a gum graft and then based on what group they were randomly assigned, they will receive either a collagen matrix where the gum graft was taken (on the palate) or nothing will be placed.

Researchers will compare non-augmented sites with augmented sites to see if there is a change in tissue thickness and volume.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The randomized controlled trial aims to investigate the potential effect of post-harvesting donor site augmentation on palatal volumetric changes following connective tissue graft harvesting.

The study investigation is a randomized controlled trial (RCT) that aims to have 20 participants in each group. The palatal thickness will be clinically assessed and a digital intraoral scan of the palate will be performed pre-operatively. A subepithelial connect tissue graft will then be harvested from the palate. Patients will then be randomly assigned to receive/not receive augmentation of the donor site, using a collagen sponge. Palatal thickness measurements and intraoral scans will be repeated at 2-, 4-, and 6-months postoperatively.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ying S Wang, DDS, MS
  • Phone Number: (214) 828-8282
  • Email: yswang@tamu.edu

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75226
        • Recruiting
        • Texas A&M College of Dentistry
        • Contact:
        • Sub-Investigator:
          • Hailey Bivens, DDS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Demographic

    1. Age: 18-65 years old
    2. Gender: Any
    3. Race: Any
    4. Non-smoker: no use of any tobacco product or nicotine-replacement products in the last 5 years

  • Medical History

    1. Physically and mentally healthy with no contraindications for periodontal surgery
    2. American Society of Anesthesiologists: ASA-I or ASA-II

  • Dental history

    1. Periodontally healthy
    2. No history of surgical interventions in the palate
    3. No history of cleft lip/palate
    4. No history of orthodontic treatment involving the palate (palatal expansion).

  • Other

    1. Patients requiring mucogingival surgery involving connective tissue graft harvesting from the palate.
    2. Patients who are able and willing to provide informed consent
    3. Patients who are able and willing to follow study appointments

Exclusion Criteria:

  • i. Medical History

    1. Smokers or users of nicotine replacement products
    2. Patients with a contraindication, e.g., allergy, for any of the medications or materials used in the study (benzocaine, lidocaine, chlorhexidine rinse, ibuprofen, acetaminophen, Glycolon ® sutures, collagen sponge matrix)
    3. Patients with diabetes (glycemic level > 110mg/l and HbA1c > 6.5%)
    4. Drug or alcohol abuse history
    5. Pregnancy, lactation.
    6. Patients with a history of bisphosphonate therapy, radiotherapy in the head and neck region for malignancies, or chemotherapy for treatment of malignant tumors
    7. Coagulation disorders or other systemic conditions affecting surgical or wound healing process and gingival tissues, such as cancer, HIV, metabolic bone diseases etc.
    8. Medications affecting periodontal status in the previous 6 months
    9. Medications affecting surgical or wound healing process and gingival tissues, such as phenytoin, cyclosporine, dihydropyridines, etc.

  • Dental

    1. Patients with any history of palatal surgery
    2. Patients with inadequate donor site anatomy

    3. Poor oral hygiene

      1. Full-mouth plaque ≥ 20%
      2. Bleeding scores > 10%

    4. Untreated periodontitis

      1. Pocket depths > 3mm with BOP
      2. No active periodontal disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Individuals with no addition of intervention (collagen matrix) after harvesting from the palate for a subepithelial connective tissue graft.
Experimental: Collagen Matrix
Individuals with the addition of the intervention (collagen matrix) after harvesting form the palate for a subepithelial connective tissue graft.
Device: Use of collagen matrix after subepithelial connective tissue graft harvest
A collagen matrix is placed under the overlying flap after the subepithelial connective tissue graft harvesting.
Other Names:
  • Experimental
  • Helistat - collagen matrix group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Palatal Thickness Change
Time Frame: 2 months, 4 months, 6 months
Initial palatal thickness of first and second surgery will be measured prior to each surgical incision with an endodontic reamer
2 months, 4 months, 6 months
Palatal Volume Change
Time Frame: 2 months, 4 months, 6 months
Palatal volume change will be compared using an intraoral scan where the scans will be overlayed to compare differences is volume change.
2 months, 4 months, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hailey Bivens

Investigators

  • Principal Investigator: Ying S Wang, DDS, MS, Texas A&M School of Dentistry

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

March 30, 2025

Study Registration Dates

First Submitted

July 16, 2023

First Submitted That Met QC Criteria

July 16, 2023

First Posted (Actual)

July 27, 2023

Study Record Updates

Last Update Posted (Estimated)

January 19, 2024

Last Update Submitted That Met QC Criteria

January 17, 2024

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB2023-0028

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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