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

Primary Purpose

Recession, Gingival

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Use of collagen matrix after subepithelial connective tissue graft harvest
Sponsored by
Hailey Bivens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Recession, Gingival focused on measuring Subepithelial connective tissue graft, Collagen matrix, Collagen sponge, Soft tissue augmentation, Palatal volumetric change

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Demographic Age: 18-65 years old Gender: Any Race: Any Non-smoker: no use of any tobacco product or nicotine-replacement products in the last 5 years Medical History Physically and mentally healthy with no contraindications for periodontal surgery American Society of Anesthesiologists: ASA-I or ASA-II Dental history Periodontally healthy No history of surgical interventions in the palate No history of cleft lip/palate No history of orthodontic treatment involving the palate (palatal expansion). Other Patients requiring mucogingival surgery involving connective tissue graft harvesting from the palate. Patients who are able and willing to provide informed consent Patients who are able and willing to follow study appointments Exclusion Criteria: i. Medical History Smokers or users of nicotine replacement products 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) Patients with diabetes (glycemic level > 110mg/l and HbA1c > 6.5%) Drug or alcohol abuse history Pregnancy, lactation. Patients with a history of bisphosphonate therapy, radiotherapy in the head and neck region for malignancies, or chemotherapy for treatment of malignant tumors Coagulation disorders or other systemic conditions affecting surgical or wound healing process and gingival tissues, such as cancer, HIV, metabolic bone diseases etc. Medications affecting periodontal status in the previous 6 months Medications affecting surgical or wound healing process and gingival tissues, such as phenytoin, cyclosporine, dihydropyridines, etc. Dental Patients with any history of palatal surgery Patients with inadequate donor site anatomy Poor oral hygiene Full-mouth plaque ≥ 20% Bleeding scores > 10% Untreated periodontitis Pocket depths > 3mm with BOP No active periodontal disease

Sites / Locations

  • Texas A&M College of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Collagen Matrix

Arm Description

Individuals with no addition of intervention (collagen matrix) after harvesting from the palate for a subepithelial connective tissue graft.

Individuals with the addition of the intervention (collagen matrix) after harvesting form the palate for a subepithelial connective tissue graft.

Outcomes

Primary Outcome Measures

Palatal Thickness Change
Initial palatal thickness of first and second surgery will be measured prior to each surgical incision with an endodontic reamer
Palatal Volume Change
Palatal volume change will be compared using an intraoral scan where the scans will be overlayed to compare differences is volume change.

Secondary Outcome Measures

Full Information

First Posted
July 16, 2023
Last Updated
July 16, 2023
Sponsor
Hailey Bivens
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1. Study Identification

Unique Protocol Identification Number
NCT05961566
Brief Title
Palatal Volumetric Change Analysis Following Connective Tissue Graft With and Without Donor Site Augmentation
Official Title
Palate Volumetric Change Analysis Following Connective Tissue Graft Harvesting With and Without Donor Site Augmentation: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
March 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hailey Bivens

4. Oversight

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

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recession, Gingival
Keywords
Subepithelial connective tissue graft, Collagen matrix, Collagen sponge, Soft tissue augmentation, Palatal volumetric change

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Individuals will be randomly assigned to be in the control group of the intervention group (Collagen matrix soft tissue augmentation).
Masking
Outcomes Assessor
Masking Description
Individuals computing the statistical analysis will be masked for which outcome was used. Surgeons and patients will only know which outcome will be used at time of surgery.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Individuals with no addition of intervention (collagen matrix) after harvesting from the palate for a subepithelial connective tissue graft.
Arm Title
Collagen Matrix
Arm Type
Experimental
Arm Description
Individuals with the addition of the intervention (collagen matrix) after harvesting form the palate for a subepithelial connective tissue graft.
Intervention Type
Device
Intervention Name(s)
Use of collagen matrix after subepithelial connective tissue graft harvest
Other Intervention Name(s)
Helistat - collagen matrix group, Experimental
Intervention Description
A collagen matrix is placed under the overlying flap after the subepithelial connective tissue graft harvesting.
Primary Outcome Measure Information:
Title
Palatal Thickness Change
Description
Initial palatal thickness of first and second surgery will be measured prior to each surgical incision with an endodontic reamer
Time Frame
2 months, 4 months, 6 months
Title
Palatal Volume Change
Description
Palatal volume change will be compared using an intraoral scan where the scans will be overlayed to compare differences is volume change.
Time Frame
2 months, 4 months, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Demographic Age: 18-65 years old Gender: Any Race: Any Non-smoker: no use of any tobacco product or nicotine-replacement products in the last 5 years Medical History Physically and mentally healthy with no contraindications for periodontal surgery American Society of Anesthesiologists: ASA-I or ASA-II Dental history Periodontally healthy No history of surgical interventions in the palate No history of cleft lip/palate No history of orthodontic treatment involving the palate (palatal expansion). Other Patients requiring mucogingival surgery involving connective tissue graft harvesting from the palate. Patients who are able and willing to provide informed consent Patients who are able and willing to follow study appointments Exclusion Criteria: i. Medical History Smokers or users of nicotine replacement products 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) Patients with diabetes (glycemic level > 110mg/l and HbA1c > 6.5%) Drug or alcohol abuse history Pregnancy, lactation. Patients with a history of bisphosphonate therapy, radiotherapy in the head and neck region for malignancies, or chemotherapy for treatment of malignant tumors Coagulation disorders or other systemic conditions affecting surgical or wound healing process and gingival tissues, such as cancer, HIV, metabolic bone diseases etc. Medications affecting periodontal status in the previous 6 months Medications affecting surgical or wound healing process and gingival tissues, such as phenytoin, cyclosporine, dihydropyridines, etc. Dental Patients with any history of palatal surgery Patients with inadequate donor site anatomy Poor oral hygiene Full-mouth plaque ≥ 20% Bleeding scores > 10% Untreated periodontitis Pocket depths > 3mm with BOP No active periodontal disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ying S Wang, DDS, MS
Phone
(214) 828-8282
Email
yswang@tamu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Hailey Bivens, DDS
Email
heb2025@tamu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ying S Wang, DDS, MS
Organizational Affiliation
Texas A&M School of Dentistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas A&M College of Dentistry
City
Dallas
State/Province
Texas
ZIP/Postal Code
75226
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ying S Wang, DDS, MS
Phone
214-828-8282
Email
yswang@tamu.edu
First Name & Middle Initial & Last Name & Degree
Hailey Bivens, DDS

12. IPD Sharing Statement

Plan to Share IPD
No

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

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