Gingival RecessionGFG-US-RECNCT04260152
Evaluation of Geistlich Fibro-Gide® + CAF in Comparison to CTG + CAF for the Treatment of Recession Defects at 6 Months
A study testing Geistlich Fibro-Gide and Connective Tissue Graft (CTG in people with Gingival Recession, run by Geistlich Pharma AG at 3 sites in United States.
Trial summary
This double blind, randomized, split mouth study evaluates the non-inferiority of Geistlich Fibro-Gide® in comparison to connective tissue graft for the treatment of Miller Class I or II recession defects at 6 months post treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gingival Recession
- What is being tested?
- Geistlich Fibro-Gide and Connective Tissue Graft (CTG
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Sep 2018to 22 Jul 2020
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 75 years of age, inclusive.
- Subjects must have at least two teeth with buccal Miller Class I or II recession type defects, 3 mm deep and 3 mm wide on the same tooth in the contralateral quadrant of the same jaw
- Defects should be similar in size and morphology
- Teeth with root canals should be asymptomatic, completed at least 6 months prior
- At least 1mm KT
- Subjects with parafunctional habits must wear a bite guard to be included.
Who cannot join
- Participation within the previous 30 days in other investigational clinical trials.
- Class V restorations or abfractions that obliterate the CEJ.
- Subjects whose teeth have extremely prominent root surfaces -greater than 2mm facially to the adjacent teeth measured at the level of the CEJ.
- Systemic conditions that could influence wound healing or any other conditions that would preclude periodontal surgery.
- Taking medications that compromise wound healing.
- Acute infectious lesions in the areas intended for surgery.
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- Untreated moderate to severe periodontal disease.
- Weekly or more frequent use of nicotine products within the past 6 months.
- Females who are pregnant or lactating, or sexually active female subjects who are of childbearing potential and who are not using hormonal or barrier methods of birth control.
- Subjects who require sedation in order to undergo surgery.
- Molars, teeth with axial mobility or interproximal loss of attachment, or full coverage crowns or veneers do not qualify.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Seven Lakes Periodontitis
Fenton, Michigan, 99999
Perio Health Professionals
Houston, Texas, 77063
Oral Health Specialists
Tacoma, Washington, 99999
About this study
Official title: A Prospective, Randomized, Controlled, Double-blind, Multi-center Study to Assess Non-inferiority of Geistlich Fibro-Gide® in Comparison to Connective Tissue Graft for the Treatment of Recession Defects
This double blind, randomized, split mouth study evaluates the non-inferiority of Geistlich Fibro-Gide® in comparison to connective tissue graft for the treatment of Miller Class I or II recession defects at 6 months post treatment.
Read the detailed description
This double blind, randomized, split mouth study evaluates the non-inferiority of Geistlich Fibro-Gide® in comparison to connective tissue graft for the treatment of Miller Class I or II recession defects at 6 months post treatment.
A total sample size of 30 subjects (n=30) will be evaluated at 3 centers with 4 investigators. Power analysis based on 80% power and past McGuire/ Scheyer matched-pair defect recession coverage studies, with one-sided confidence interval 0.025, indicates that in order to detect a 12% difference in root coverage with ± 15% standard deviation a patient sample of 25 should be used . Given the multi-center nature of this study and the intention to follow patients long-term, with normal attrition, 30 subjects will ensure adequate long-term follow-up and provide a "power buffer" for any outcome differences that might be seen between centers.
30 Patients with Miller Class I or II recession defects on bilateral sites will be treated randomly with coronally advanced flap (CAF) in combination with either Geistlich Fibro-Gide (GFG =Test) on one side, and Connective Tissue Graft (CTG = Control) on the contralateral side of the mouth. Follow-up visits after visit 2 surgery will be conducted at week 1,2, 4,12 and 24 and in the long term after 1,3 and 5 years.
- Conditions
- Gingival Recession
- Being tested
- Geistlich Fibro-Gide, Connective Tissue Graft (CTG
- Keywords
- Gingival Recession, Fibro-Gide, CAF, CTG, Geistlich
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Geistlich Fibro-GideDevice
Also called Coronally advanced Flap (surgery/ procedure)
Surgical recession root coverage with coronally advanced flap in combination with Geistlich Fibro-Gide
Connective Tissue Graft (CTGProcedure or surgery
Also called Coronally advanced Flap (surgery/ procedure)
Surgical recession root coverage with coronally advanced flap in combination with CTG
| Study group | Role | What they receive |
|---|---|---|
| Control: CAF + CTG | Active comparator | Following root preparation and conditioning, the CTG is obtained from the palate according to the randomization scheme and shaped to the recipient site and may be sutured to the papilla region and the coronally advanced flap (CAF) is sutured into place. Receives: Procedure: Connective Tissue Graft (CTG |
| Test: CAF + Geistlich Fibro-Gide® (test) | Experimental | Following root preparation and conditioning, Geistlich Fibro-Gide® is cut to size and shaped to the recipient and may be sutured and the coronally advanced flap (CAF) is sutured into place. Receives: Device: Geistlich Fibro-Gide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in percent root coverage
Change in percent root coverage compared to baseline
Measured: 6 months post-treatment
Secondary outcomes (10)
Safety Endpoints: number and frequency of (S)AEs over all and by organ class
Assessment of (S)AEs starting at Visit 2, Surgery
Measured: 1, 2, 4, 7, 12 and 24 weeks and year 1,3 and 5 post treatment
General Periodontal Examination (GPE)
change of GPE at various visits compared to baseline, scoring codes 0-4
Measured: baseline (day 0) and 6 months; 1, 3, 5 years post-treatment
Assessment of Wound Healing
Judgement of soft tissue wound healing after surgery at Visits 3-6; Primary complete wound closure? yes = complete/ no = dehiscence visible
Measured: 1, 2, 4, 12 weeks post-treatment
Assessment of Wound Healing
Judgement of soft tissue wound healing after surgery at Visits 3-6; if dehiscence visible, dehiscence size: lenght and width in mm
Measured: 1, 2, 4, 12 weeks post-treatment
Assessment of Wound Healing
Judgement of soft tissue wound healing after surgery at Visits 3-6; presence of Swelling (yes/ no),
Measured: 1, 2, 4, 12 weeks post-treatment
Overall Duration of Treatment Surgery
Interval from surgery start until surgery end in Hours/Minutes
Measured: 2-6 hours at day of surgery
Patient Reported Outcome (PRO) -Patient Diary: Discomfort
Post-Op PRO Discomfort Diary completed by Patients at home; scale 0-10, 0=no pain or discomfort at all, 10=as much as you can imagine,
Measured: 7 days after surgery starting 1 day after surgery
Patient Reported Outcome (PRO) -Questionnaire: Esthetics
Post-Op PRO questionnaire, Esthetics and overall satisfaction, patients will be asked by a 3rd party recorder, scale 0-10, 0=not satisfied at all with estehtic appearance, 10=completely satisfied,
Measured: 6 months, 1, 3, 5 years post-treatment
Patient Reported Outcome (PRO) -Questionnaire: for surgical preference
Post-Op PRO questionnaire, Surgival procedure Preference, patients will be asked by a 3rd party recorder, Overall which treatment did you prefer? A or B
Measured: 1, 2, 4, 12 weeks, 6 months, 1, 3, 5 years post-treatment
Safety endpoints: Concomitant Medication
Use of Concomitant medication Review: Type of concomitant Medication used.
Measured: 1, 2, 4, 12 weeks, 6 months, 1, 3, 5 years post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start1 Sep 2018
- Primary completion4 Jan 2020
- Study completion22 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival RecessionStudies of the same condition, open and under way.
- 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
- Split-mouth, randomized
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geistlich Pharma AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medelis Inc.
- Responsible party
- Sponsor
- Investigators
- Michael K McGuire, DDS MSD, Principal investigator, PerioHealth Professionals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04260152
- Sponsor's protocol ID
- 10808-121
- Acronym
- GFG-US-REC
- Status last verified
- Mar 2020
- First submitted
- 18 Sep 2019
- Last updated
- 10 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled, Double-blind, Multi-center Study to Assess Non-inferiority of Geistlich Fibro-Gide® in Comparison to Connective Tissue Graft for the Treatment of Recession Defects
- ClinicalTrials.gov ID
- NCT04260152
- Acronym / sponsor ID
- GFG-US-REC / 10808-121
- Conditions
- Gingival Recession
- Keywords
- Gingival Recession, Fibro-Gide, CAF, CTG, Geistlich
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Geistlich Pharma AGIndustry (pharma, biotech, devices)
- Collaborators
- Medelis Inc.
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 4 Jan 2020 (actual)
- Study completion
- 22 Jul 2020 (actual)
- First posted
- 7 Feb 2020 (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.
This double blind, randomized, split mouth study evaluates the non-inferiority of Geistlich Fibro-Gide® in comparison to connective tissue graft for the treatment of Miller Class I or II recession defects at 6 months post treatment.
Detailed description
This double blind, randomized, split mouth study evaluates the non-inferiority of Geistlich Fibro-Gide® in comparison to connective tissue graft for the treatment of Miller Class I or II recession defects at 6 months post treatment.
A total sample size of 30 subjects (n=30) will be evaluated at 3 centers with 4 investigators. Power analysis based on 80% power and past McGuire/ Scheyer matched-pair defect recession coverage studies, with one-sided confidence interval 0.025, indicates that in order to detect a 12% difference in root coverage with ± 15% standard deviation a patient sample of 25 should be used . Given the multi-center nature of this study and the intention to follow patients long-term, with normal attrition, 30 subjects will ensure adequate long-term follow-up and provide a "power buffer" for any outcome differences that might be seen between centers.
30 Patients with Miller Class I or II recession defects on bilateral sites will be treated randomly with coronally advanced flap (CAF) in combination with either Geistlich Fibro-Gide (GFG =Test) on one side, and Connective Tissue Graft (CTG = Control) on the contralateral side of the mouth. Follow-up visits after visit 2 surgery will be conducted at week 1,2, 4,12 and 24 and in the long term after 1,3 and 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Split-mouth, randomized
| Arm | Type | Receives |
|---|---|---|
| Control: CAF + CTG | Active comparator | Procedure: Connective Tissue Graft (CTGFollowing root preparation and conditioning, the CTG is obtained from the palate according to the randomization scheme and shaped to the recipient site and may be sutured to the papilla region and the coronally advanced flap (CAF) is sutured into place. |
| Test: CAF + Geistlich Fibro-Gide® (test) | Experimental | Device: Geistlich Fibro-GideFollowing root preparation and conditioning, Geistlich Fibro-Gide® is cut to size and shaped to the recipient and may be sutured and the coronally advanced flap (CAF) is sutured into place. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 to 75 years of age, inclusive.
- Subjects must have at least two teeth with buccal Miller Class I or II recession type defects, 3 mm deep and 3 mm wide on the same tooth in the contralateral quadrant of the same jaw
- Defects should be similar in size and morphology
- Teeth with root canals should be asymptomatic, completed at least 6 months prior
- At least 1mm KT
Key exclusion criteria (11 listed)
- Participation within the previous 30 days in other investigational clinical trials.
- Class V restorations or abfractions that obliterate the CEJ.
- Subjects whose teeth have extremely prominent root surfaces -greater than 2mm facially to the adjacent teeth measured at the level of the CEJ.
- Systemic conditions that could influence wound healing or any other conditions that would preclude periodontal surgery.
- Taking medications that compromise wound healing.
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 |
|---|---|---|
| Geistlich Fibro-GideAlso: Coronally advanced Flap (surgery/ procedure)Surgical recession root coverage with coronally advanced flap in combination with Geistlich Fibro-Gide | Device | Test: CAF + Geistlich Fibro-Gide® (test) |
| Connective Tissue Graft (CTGAlso: Coronally advanced Flap (surgery/ procedure)Surgical recession root coverage with coronally advanced flap in combination with CTG | Procedure or surgery | Control: CAF + CTG |
Primary outcome
Change in percent root coverage
Time frame: 6 months post-treatment
Change in percent root coverage compared to baseline
10 secondary outcomes
Safety Endpoints: number and frequency of (S)AEs over all and by organ class
Time frame: 1, 2, 4, 7, 12 and 24 weeks and year 1,3 and 5 post treatment
General Periodontal Examination (GPE)
Time frame: baseline (day 0) and 6 months; 1, 3, 5 years post-treatment
Assessment of Wound Healing
Time frame: 1, 2, 4, 12 weeks post-treatment
Assessment of Wound Healing
Time frame: 1, 2, 4, 12 weeks post-treatment
Assessment of Wound Healing
Time frame: 1, 2, 4, 12 weeks post-treatment
Overall Duration of Treatment Surgery
Time frame: 2-6 hours at day of surgery
Patient Reported Outcome (PRO) -Patient Diary: Discomfort
Time frame: 7 days after surgery starting 1 day after surgery
Patient Reported Outcome (PRO) -Questionnaire: Esthetics
Time frame: 6 months, 1, 3, 5 years post-treatment
Patient Reported Outcome (PRO) -Questionnaire: for surgical preference
Time frame: 1, 2, 4, 12 weeks, 6 months, 1, 3, 5 years post-treatment
Safety endpoints: Concomitant Medication
Time frame: 1, 2, 4, 12 weeks, 6 months, 1, 3, 5 years post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2021.
- Individual participant dataSharing planned: No
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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.
Michael K McGuire, DDS MSD principal investigator
PerioHealth Professionals
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Geistlich Fibro-Gide and Connective Tissue Graft (CTG in people with Gingival Recession, run by Geistlich Pharma AG at 3 sites in United States.
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 6 inclusion and 11 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: finished, as of the sponsor's last update on 10 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in percent root coverage (time frame: 6 months post-treatment). 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 10 Aug 2021.