Thin GingivaNCT05295771
Evaluation of Geistlich Fibro-Gide ® and Autogenous Connective Tissue Graft Prior to Orthodontic Maxillary Expansion.
A study testing Gingival Phenotype Modification in people with Thin Gingiva and Transverse Maxillary Deficiency, run by University of Alberta at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Thin Gingiva, Transverse Maxillary Deficiency, Cross Bite
- What is being tested?
- Gingival Phenotype Modification
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2022to 23 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Alberta, Kaye Edmonton Clinic
Edmonton, Alberta, T6G 2H5
About this study
Official title: Evaluation of Geistlich Fibro-Gide ® in Comparison to Autogenous Connective Tissue Graft in Gingival Phenotype Modification Prior to Orthodontic Maxillary Expansion.
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.
Read the 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.
- Conditions
- Thin Gingiva, Transverse Maxillary Deficiency, Cross Bite
- Being tested
- Gingival Phenotype Modification
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gingival Phenotype ModificationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Test arm | Experimental | Geistlich Fibro-Gide ®. Receives: Procedure: Gingival Phenotype Modification |
| Control | Active comparator | Autogenous Connective Tissue Graft. Receives: Procedure: Gingival Phenotype Modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before orthodontic treatment commences on average 4 weeks after surgery.
Keratinized Tissue Width
Measure the width from the free gingival margin to the mucogingival junction at the site of surgical intervention.
Measured: 12 weeks after surgery
Keratinized Tissue Width
Measure the width from the free gingival margin to the mucogingival junction at the site of surgical intervention.
Measured: 24 weeks after surgery
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.
Measured: 12 weeks after surgery
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.
Measured: 24 weeks after surgery
Secondary outcomes (7)
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.
Measured: Day of surgical intervention
Visual Analog Score for Pain
To assess the level of pain experienced by the patient due to the surgical intervention.
Measured: One day after surgery.
Visual Analog Score for Pain
To assess the level of pain experienced by the patient due to the surgical intervention.
Measured: 2 weeks after surgery.
Visual Analog Score for Discomfort
To assess the level of discomfort experienced by the patient due to the surgical intervention.
Measured: One day after surgery.
Visual Analog Score for Discomfort
To assess the level of discomfort experienced by the patient due to the surgical intervention.
Measured: 2 weeks after surgery.
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.
Measured: 2 weeks after surgery.
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.
Measured: 4 weeks after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start1 Apr 2022
- Primary completion23 Jan 2024
- Study completion23 Jan 2024
Why it stopped: Unable to recruit participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thin GingivaStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Geistlich Pharma AG
- Responsible party
- Sponsor
- Investigators
- Monica P Gibson, BDS,MS(Perio),PhD,FRCD(C), Principal investigator, U of Alberta Co-Director,Perio Graduate Prog,Faculty of Medicine & Dentistry-Dentistry Dept
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05295771
- Sponsor's protocol ID
- Pro00112336
- Status last verified
- Jan 2024
- First submitted
- 23 Dec 2021
- Last updated
- 25 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Geistlich Fibro-Gide ® in Comparison to Autogenous Connective Tissue Graft in Gingival Phenotype Modification Prior to Orthodontic Maxillary Expansion.
- ClinicalTrials.gov ID
- NCT05295771
- Acronym / sponsor ID
- Pro00112336
- Conditions
- Thin Gingiva, Transverse Maxillary Deficiency, Cross Bite
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to recruit participants.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Geistlich Pharma AG
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 23 Jan 2024 (actual)
- Study completion
- 23 Jan 2024 (actual)
- First posted
- 25 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Test arm | Experimental | Procedure: Gingival Phenotype ModificationGeistlich Fibro-Gide ®. |
| Control | Active comparator | Procedure: Gingival Phenotype ModificationAutogenous Connective Tissue Graft. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gingival Phenotype ModificationAutogenous 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. | Procedure or surgery | Control, Test arm |
Primary outcome
Keratinized Tissue Thickness
Time frame: Before orthodontic treatment commences on average 4 weeks after surgery.
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
Time frame: 12 weeks after surgery
Measure the width from the free gingival margin to the mucogingival junction at the site of surgical intervention.
Keratinized Tissue Width
Time frame: 24 weeks after surgery
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
Time frame: 12 weeks after surgery
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
Time frame: 24 weeks after surgery
The gingival margin will either be at the CEJ, apical to it or coronal to it at the site of surgical intervention.
7 secondary outcomes
Duration of Surgery
Time frame: Day of surgical intervention
Visual Analog Score for Pain
Time frame: One day after surgery.
Visual Analog Score for Pain
Time frame: 2 weeks after surgery.
Visual Analog Score for Discomfort
Time frame: One day after surgery.
Visual Analog Score for Discomfort
Time frame: 2 weeks after surgery.
Wound Healing Index
Time frame: 2 weeks after surgery.
Wound Healing Index
Time frame: 4 weeks after surgery.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monica P Gibson, BDS,MS(Perio),PhD,FRCD(C) principal investigator
U of Alberta Co-Director,Perio Graduate Prog,Faculty of Medicine & Dentistry-Dentistry Dept
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gingival Phenotype Modification in people with Thin Gingiva and Transverse Maxillary Deficiency, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Keratinized Tissue Thickness (time frame: Before orthodontic treatment commences on average 4 weeks after surgery.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2024.