Evaluation of Geistlich Fibro-Gide ® and Autogenous Connective Tissue Graft Prior to Orthodontic Maxillary Expansion.
Primary Purpose
Thin Gingiva, Transverse Maxillary Deficiency, Cross Bite
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Gingival Phenotype Modification
Sponsored by
About this trial
This is an interventional treatment trial for Thin Gingiva
Eligibility Criteria
Inclusion Criteria:
- Inclusion criteria for this study include patients ranging from 13 to 17 years of age requiring maxillary expansion;
- presence of all permanent dentition, presence of unilateral or bilateral cross-bite or transverse maxillary deficiency,
- subjects must have at least one tooth with thin gingival phenotype on maxillary canines, premolars or first molars (mesial root only) on either side;
- teeth should have less than 2 mm of keratinized gingiva to be considered for surgical intervention
- subjects should be systemically health.
Exclusion Criteria:
- Exclusion criteria would include patients with previous orthodontic treatment done,
- patients with Class V restorations or abfractions that obliterate cementoenamel junction
- patients with active caries or endodontically involved teeth
- immunocompromised patients that can influence wound healing
- patients with parafunctional habits
- patient with any history of smoking
- pregnant or lactating females
- teeth that have greater than Miller grade I mobility.
Sites / Locations
- University of Alberta, Kaye Edmonton ClinicRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Test arm
Control
Arm Description
Geistlich Fibro-Gide ®.
Autogenous Connective Tissue Graft.
Outcomes
Primary Outcome Measures
Keratinized Tissue Thickness
The thickness of the keratinized gingiva will be measured on the mid buccal of the tooth 1 mm apical to the gingival margin using an endo- reamer at the site of surgical intervention.
Keratinized Tissue Width
Measure the width from the free gingival margin to the mucogingival junction at the site of surgical intervention.
Keratinized Tissue Width
Measure the width from the free gingival margin to the mucogingival junction at the site of surgical intervention.
Gingival margin level in relation to the Cemento Enamel Junction CEJ
The gingival margin will either be at the CEJ, apical to it or coronal to it at the site of surgical intervention.
Gingival margin level in relation to the Cemento Enamel Junction CEJ
The gingival margin will either be at the CEJ, apical to it or coronal to it at the site of surgical intervention.
Secondary Outcome Measures
Duration of Surgery
For both the test and control interventions, the duration of the surgical procedure will be recorded from the time of anesthesia to the time of placing the last suture.
Visual Analog Score for Pain
To assess the level of pain experienced by the patient due to the surgical intervention.
Visual Analog Score for Pain
To assess the level of pain experienced by the patient due to the surgical intervention.
Visual Analog Score for Discomfort
To assess the level of discomfort experienced by the patient due to the surgical intervention.
Visual Analog Score for Discomfort
To assess the level of discomfort experienced by the patient due to the surgical intervention.
Wound Healing Index
To assess the wound healing following surgical intervention using an index given by Huang et al 2005 that scores from 1- 3.
Wound Healing Index
To assess the wound healing following surgical intervention using an index given by Huang et al 2005 that scores from 1- 3.
Full Information
NCT ID
NCT05295771
First Posted
December 23, 2021
Last Updated
January 3, 2023
Sponsor
University of Alberta
Collaborators
Geistlich Pharma AG
1. Study Identification
Unique Protocol Identification Number
NCT05295771
Brief Title
Evaluation of Geistlich Fibro-Gide ® and Autogenous Connective Tissue Graft Prior to Orthodontic Maxillary Expansion.
Official Title
Evaluation of Geistlich Fibro-Gide ® in Comparison to Autogenous Connective Tissue Graft in Gingival Phenotype Modification Prior to Orthodontic Maxillary Expansion.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
Collaborators
Geistlich Pharma AG
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Teenage children and adults often undergo orthodontic treatment each year to improve their dental esthetics and chewing function. One common problem they present with is having a small maxilla compared to the mandible. The standard of treatment to correct this issue is to expand the maxilla using either a tooth-anchored expander, a bone-anchored expander, or braces. Unfortunately, these treatment options can sometimes result in a loss of gum tissue and supporting structures of the teeth. Certain patients, especially ones that have thin gum tissue, are at a higher risk of this gum tissue loss. Orthodontic treatment for these patients will expand their jaw, causing further pressure on already thin gums. An increasingly common treatment to prevent this is to proactively modify patient's thin tissue surgically prior to their orthodontic treatment so they can withstand the tooth movement. The gold standard of doing this surgical intervention consists of harvesting a connective tissue from the palate which is not well tolerated by the younger population. Our study will evaluate the use of a biomaterial substitute instead of harvesting the patient's own tissue to thicken the gingival tissues. Surgical healing, patient satisfaction, pain index, as well as tissue contour post orthodontic treatment will be assessed thoroughly. This study will help us understand: 1) if biomaterials can be a substitute for traditional autogenous gum grafts to help thicken the patient's gum tissue prior to orthodontic treatment, and 2) if they are able to withstand the pressure of orthodontic movement. This will be the first long-term study of this kind.
Detailed Description
This study will be a prospective, single-center, blinded, randomized, split-mouth study. Upon ethics approval from the University of Alberta research information services (ARISE), patients will be recruited from Kaye Edmonton Clinic (KEC). This study evaluates the long-term success of Geistlich Fibro-Gide® in comparison to autogenous connective tissue graft for the treatment of gingival phenotype modification of patients with thin gingiva undergoing orthodontic arch expansion in the KEC Graduate Orthodontics clinic. A total of 30 subjects (n=30) will be enrolled in this study. Sample size was estimated based on 80% power, alpha of 0.025, and results from past studies that have been conducted to detect a 10 to 15% difference in gingival tissue recession post orthodontic treatment with a 15% standard deviation (a patient sample of 25 would be ideal). Given the long-term nature of this study, with normal drop-out rates, 30 subjects will ensure an adequate sample size for effective statistical comparison.
In this study, 30 patients with bilaterally thin gingival phenotype and minimal keratinized tissues as determined by standardized studies will be treated randomly (left or right maxillary site to be randomized) with either Geistlich Fibro- Gide ® (Test arm) on one side, and autogenous connective tissue graft (Control arm) on the contralateral side of the mouth. Regular post-surgical follow-up visits will be conducted at weeks 2, 4, 12, 24, and up to 2 years post orthodontic treatment completion. Since orthodontic maxillary expansion most commonly affects maxillary molars (predominantly mesial root), canines and both premolars, the study will restrict treatment sites to only these teeth. The selection of these teeth will help distinguish directly anchored teeth (molars), having force applied through wire (premolars) and secondary expansion effect (canine). In this interventional study, each patient will be randomly assigned to receive either Fibro-Gide® or autogenous connective tissue graft (split-mouth, parallel assignment). The outcomes examiner will be blinded to the intervention used by the periodontist. The primary outcome will be measured by standardized periodontal charting and gingival measurements recorded in axiUm at each visit during the study. This will include recording clinical attachment levels, periodontal probing, gingival margin level in relation to cemento-enamel junction (CEJ), gingival phenotype class, thickness and width of keratinized tissue, periapical radiographs, and clinical photographs recorded during each phase of the study for comparative analyses. Secondary outcomes will be analyzed by utilizing standardized pain indices and post surgical wound healing assessments as described in previous studies.
Patients eligible to participate in the study will be presented with study details and relevant consent forms. Surgical incision design and suturing will be done in accordance with an envelope technique.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thin Gingiva, Transverse Maxillary Deficiency, Cross Bite
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
30 patients with bilaterally thin gingival phenotype and minimal keratinized tissues will be treated randomly (left or right maxillary site to be randomized) with either Geistlich Fibro- Gide ® (Test arm) on one side and Autogenous Connective Tissue Graft (Control arm) on the contralateral side of the mouth.
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Test arm
Arm Type
Experimental
Arm Description
Geistlich Fibro-Gide ®.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Autogenous Connective Tissue Graft.
Intervention Type
Procedure
Intervention Name(s)
Gingival Phenotype Modification
Intervention Description
Autogenous Connective Tissue Graft is the current gold standard for soft tissue phenotype modification. This is being compared with a substitute material called Geistlich Fibro-Gide ® for soft tissue phenotype modification before orthodontic treatment. Geistlich Fibro-Gide ® is a porcine, porous, resorbable and volume-stable collagen matrix, designed for soft-tissue regeneration. Surgical flap design will be an envelope for both interventions.
Primary Outcome Measure Information:
Title
Keratinized Tissue Thickness
Description
The thickness of the keratinized gingiva will be measured on the mid buccal of the tooth 1 mm apical to the gingival margin using an endo- reamer at the site of surgical intervention.
Time Frame
Before orthodontic treatment commences on average 4 weeks after surgery.
Title
Keratinized Tissue Width
Description
Measure the width from the free gingival margin to the mucogingival junction at the site of surgical intervention.
Time Frame
12 weeks after surgery
Title
Keratinized Tissue Width
Description
Measure the width from the free gingival margin to the mucogingival junction at the site of surgical intervention.
Time Frame
24 weeks after surgery
Title
Gingival margin level in relation to the Cemento Enamel Junction CEJ
Description
The gingival margin will either be at the CEJ, apical to it or coronal to it at the site of surgical intervention.
Time Frame
12 weeks after surgery
Title
Gingival margin level in relation to the Cemento Enamel Junction CEJ
Description
The gingival margin will either be at the CEJ, apical to it or coronal to it at the site of surgical intervention.
Time Frame
24 weeks after surgery
Secondary Outcome Measure Information:
Title
Duration of Surgery
Description
For both the test and control interventions, the duration of the surgical procedure will be recorded from the time of anesthesia to the time of placing the last suture.
Time Frame
Day of surgical intervention
Title
Visual Analog Score for Pain
Description
To assess the level of pain experienced by the patient due to the surgical intervention.
Time Frame
One day after surgery.
Title
Visual Analog Score for Pain
Description
To assess the level of pain experienced by the patient due to the surgical intervention.
Time Frame
2 weeks after surgery.
Title
Visual Analog Score for Discomfort
Description
To assess the level of discomfort experienced by the patient due to the surgical intervention.
Time Frame
One day after surgery.
Title
Visual Analog Score for Discomfort
Description
To assess the level of discomfort experienced by the patient due to the surgical intervention.
Time Frame
2 weeks after surgery.
Title
Wound Healing Index
Description
To assess the wound healing following surgical intervention using an index given by Huang et al 2005 that scores from 1- 3.
Time Frame
2 weeks after surgery.
Title
Wound Healing Index
Description
To assess the wound healing following surgical intervention using an index given by Huang et al 2005 that scores from 1- 3.
Time Frame
4 weeks after surgery.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Inclusion criteria for this study include patients ranging from 13 to 17 years of age requiring maxillary expansion;
presence of all permanent dentition, presence of unilateral or bilateral cross-bite or transverse maxillary deficiency,
subjects must have at least one tooth with thin gingival phenotype on maxillary canines, premolars or first molars (mesial root only) on either side;
teeth should have less than 2 mm of keratinized gingiva to be considered for surgical intervention
subjects should be systemically health.
Exclusion Criteria:
Exclusion criteria would include patients with previous orthodontic treatment done,
patients with Class V restorations or abfractions that obliterate cementoenamel junction
patients with active caries or endodontically involved teeth
immunocompromised patients that can influence wound healing
patients with parafunctional habits
patient with any history of smoking
pregnant or lactating females
teeth that have greater than Miller grade I mobility.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Co-Director Periodontology Graduate Program U of A
Phone
780-492-8444
Email
mgibson@ualberta.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Anum Haider, BDS
Phone
587-921-9521
Email
ahaider2@ualberta.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monica P Gibson, BDS,MS(Perio),PhD,FRCD(C)
Organizational Affiliation
U of Alberta Co-Director,Perio Graduate Prog,Faculty of Medicine & Dentistry-Dentistry Dept
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta, Kaye Edmonton Clinic
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2H5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monica P Gibson, BDS,MS Periodontics,PhD,FRCD
Phone
780-492-8444
Email
mgibson@ualberta.ca
First Name & Middle Initial & Last Name & Degree
Anum Haider, BDS
Phone
587-921-9521
Email
ahaider2@ualberta.ca
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Geistlich Fibro-Gide ® and Autogenous Connective Tissue Graft Prior to Orthodontic Maxillary Expansion.
We'll reach out to this number within 24 hrs