Soft Tissue DefectNCT04703738
Evaluation of Geistlich Fibro-Gide® in Comparison to CTG for the Treatment Around Implants
A study testing Soft tissue flap + Connective Tissue Graft and Soft tissue flap + Geistlich Fibro-Gide® in people with Soft Tissue Defect, run by Geistlich Pharma AG at 5 sites in United States.
Trial summary
This double blind, randomized, parallel study evaluates the non-inferiority of Geistlich Fibro-Gide® in comparison to connective tissue graft for soft tissue volume augmentation around dental implants Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Soft Tissue Defect
- What is being tested?
- Soft tissue flap + Connective Tissue Graft and Soft tissue flap + Geistlich Fibro-Gide®
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 5 sitesUnited States
- Study dates
- 13 Aug 2018to 12 May 2026
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects requiring soft tissue augmentation around single implants, i.e., thin biotype with potential for
- All implants must be at least 6 months post bone graft/implant placement
- have at least 1 mm of keratinized tissue width (KTw),
- have final restoration permanently in place for at least 4-weeks and
- subject have no recession on the implant body
- Subjects who, can achieve good oral hygiene (80% plaque free surfaces on the implant and maintain 80% plaque free surfaces on teeth adjacent to treatment sites).
Who cannot join
- participation within the last six months in other interventional studies.
- any systemic condition that could influence healing, such as uncontrolled diabetes mellitus - confirmed by A1C score ≥7% - cancer, HIV, oral muco- cutaneous conditions and drug induced gingival enlargement.
- taking medications that compromise wound healing, such as chronic steroid use - either inhaler or systemic, calcium channel blockers with secondary hyperplastic tissue reactions, anti-seizure medications, IV bisphosphates for bone metabolic diseases, radiation or other immuno-suppressive therapy.
- acute infectious lesions in the areas intended for surgery.
- History within the last 6 months of weekly or more frequent use of nicotine products
- Female subjects 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
- Untreated, moderate to severe periodontal disease.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
McClain Schallhorn Periodonitcs
Aurora, Colorado, 80012-3202
Regenerative Solutions
Fullerton, California, 92835
Perio Health Professionals
Houston, Texas, 77063
Santarelli Oral and Facial Surgery
Kenosha, Wisconsin, 53144
Periodontal and Dental Implant Surgical Specialist
Virginia City, Virginia, 23226
About this study
Official title: A Prospective, Randomized and Controlled Multi-center Study of Geistlich Fibro-Gide® Compared With Connective Tissue Graft for Soft Tissue Volume Augmentation Around Dental Implants
This double blind, randomized, parallel study evaluates the non-inferiority of Geistlich Fibro-Gide® in comparison to connective tissue graft for soft tissue volume augmentation around dental implants
Read the detailed description
A total sample size of 60 subjects (n=60) will be evaluated at 5 centers, by 6 Investigators with approximately 10-subjects per Investigator. Power analysis based on 80% power, past Thoma, Zeltner and González-Martin studies 1,2,3 and a one-sided confidence interval of 0.025, indicates that with a volume change standard deviation between 0.5 and 0.7 mm, 17-31 subjects are required per group (test and control), so 50-60 subjects are an acceptable estimate, with a preference for 60, given potential loss to long-term follow-up.
- Conditions
- Soft Tissue Defect
- Being tested
- Soft tissue flap + Connective Tissue Graft, Soft tissue flap + Geistlich Fibro-Gide®
- Keywords
- soft tissue augmentation, soft tissue volume, Fibro-Gide, CTG, Geistlich
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soft tissue flap + Connective Tissue GraftProcedure or surgery
The treatment site is accessed using a full thickness flap extending at least 1 full tooth mesial and distal, vertical releasing incisions may be used to obtain flap release for full coverage of the treatment site and graft without compression. The harvest graft donor area will be the palate in the bicuspid region on the same side as the control soft tissue augmentation therapy. The CTG will be harvested using full thickness incisions that include the periosteum and will be closed using suture and coating the incision line with a tissue adhesive. No covering stents or packs should be employed. The CTG will be sling sutured in place and the flap secured using a double sling suturing technique.
Soft tissue flap + Geistlich Fibro-Gide®Device
The treatment site is accessed using a full thickness flap extending at least 1 full tooth mesial and distal, vertical releasing incisions may be used to obtain flap release for full coverage of the treatment site and matrix without compression. Geistlich Fibro-Gide® is cut to shape to the treatment site and placed dry into the site. The flap is secured using a double sling suturing technique.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Soft tissue flap + Connective Tissue Graft Receives: Procedure: Soft tissue flap + Connective Tissue Graft |
| Test | Experimental | Soft tissue flap + Geistlich Fibro-Gide® Receives: Device: Soft tissue flap + Geistlich Fibro-Gide® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gingival soft tissue volume assessed with 3D scanning
Change in gingival soft tissue volume compared to baseline [Time Frame 6 months post-treatment] Measured by digital contour scan
Measured: 6 months post treatment
Secondary outcomes (6)
All Adverse Events, serious and non serious
Recording and Assessment of all (S)AEs starting from Visit 2 onwards, Surgery
Measured: Day 0, after 2, 4, 12weeks, 6 Months, 1,3,5 Years
Post-OP Patient Reported Outcome Questionnaire
subjects will answer a questionnaire regarding discomfort, esthetic satisfaction and overall satisfaction questions asked by a 3rd-party rec
At Visits 2-weeks, and 1- and 3-months post-operative, subjects will answer discomfort/ pain questions asked by a 3rd-party recorder.
Measured: 6 Months, 1,3,5 Years
Concomitant medication
Concomitant medication review compared with Visit 1 and 2
Measured: 2,4,12 weeks, 6 months, 1,3,5 Years
Change in gingival soft tissue contour
soft tissue contour measured digitally ( 3D-scan) and compared with baseline
Measured: 3 months, 1,3, 5 Years
General Periodontal Examination (GPE)
Changes of GPE at various visits compared to baseline,
Measured: 4, 12 weeks, 6 Months, 1,3,5 Years
Pink esthetic score (PES)
pink esthetic score evaluates soft tissue around single-tooth implants. The PES is based on seven variables: Mesial papilla, Distal papilla, Soft tissue Level, Soft-tissue contour, Alveolar process deficiency, Soft-tissue Color, Soft tissue texture, 2-1-0 score
Measured: 6 Months, 1,3,5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start13 Aug 2018
- Primary completion21 Jun 2021
- Study completion12 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Soft Tissue DefectStudies 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
- parallel, randomized, controlled, single-blind, multi-centre clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geistlich Pharma AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medelis Inc.
- Responsible party
- Sponsor
- Investigators
- Donald S Clem III, DDS, Principal investigator, Regenative Solutions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04703738
- Sponsor's protocol ID
- 10808-122
- Status last verified
- Sep 2026
- First submitted
- 23 Nov 2020
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Clem DS, McClain PK, McGuire MK, Richardson CR, Santarelli GA, Schallhorn RA, Scheyer ET, Gunsolley JC, Morelli T. Harvest graft substitute for soft tissue volume augmentation around existing implants: A randomized, controlled and blinded multicenter trial. J Periodontol. 2024 Aug;95(8):740-748. doi: 10.1002/JPER.23-0305. Epub 2023 Dec 9.
PubMed 38071454
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized and Controlled Multi-center Study of Geistlich Fibro-Gide® Compared With Connective Tissue Graft for Soft Tissue Volume Augmentation Around Dental Implants
- ClinicalTrials.gov ID
- NCT04703738
- Acronym / sponsor ID
- 10808-122
- Conditions
- Soft Tissue Defect
- Keywords
- soft tissue augmentation, soft tissue volume, Fibro-Gide, CTG, Geistlich
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Geistlich Pharma AGIndustry (pharma, biotech, devices)
- Collaborators
- Medelis Inc.
- Study start
- 13 Aug 2018 (actual)
- Primary completion
- 21 Jun 2021 (actual)
- Study completion
- 12 May 2026 (actual)
- First posted
- 11 Jan 2021 (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, parallel study evaluates the non-inferiority of Geistlich Fibro-Gide® in comparison to connective tissue graft for soft tissue volume augmentation around dental implants
Detailed description
A total sample size of 60 subjects (n=60) will be evaluated at 5 centers, by 6 Investigators with approximately 10-subjects per Investigator. Power analysis based on 80% power, past Thoma, Zeltner and González-Martin studies 1,2,3 and a one-sided confidence interval of 0.025, indicates that with a volume change standard deviation between 0.5 and 0.7 mm, 17-31 subjects are required per group (test and control), so 50-60 subjects are an acceptable estimate, with a preference for 60, given potential loss to long-term follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- parallel, randomized, controlled, single-blind, multi-centre clinical trial
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Procedure: Soft tissue flap + Connective Tissue GraftSoft tissue flap + Connective Tissue Graft |
| Test | Experimental | Device: Soft tissue flap + Geistlich Fibro-Gide®Soft tissue flap + Geistlich Fibro-Gide® |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects requiring soft tissue augmentation around single implants, i.e., thin biotype with potential for
- All implants must be at least 6 months post bone graft/implant placement
- have at least 1 mm of keratinized tissue width (KTw),
- have final restoration permanently in place for at least 4-weeks and
- subject have no recession on the implant body
Key exclusion criteria (7 listed)
- participation within the last six months in other interventional studies.
- any systemic condition that could influence healing, such as uncontrolled diabetes mellitus - confirmed by A1C score ≥7% - cancer, HIV, oral muco- cutaneous conditions and drug induced gingival enlargement.
- taking medications that compromise wound healing, such as chronic steroid use - either inhaler or systemic, calcium channel blockers with secondary hyperplastic tissue reactions, anti-seizure medications, IV bisphosphates for bone metabolic diseases, radiation or other immuno-suppressive therapy.
- acute infectious lesions in the areas intended for surgery.
- History within the last 6 months of weekly or more frequent use of nicotine products
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 |
|---|---|---|
| Soft tissue flap + Connective Tissue GraftThe treatment site is accessed using a full thickness flap extending at least 1 full tooth mesial and distal, vertical releasing incisions may be used to obtain flap release for full coverage of the treatment site and graft without compression. The harvest graft donor area will be the palate in the bicuspid region on the same side as the control soft tissue augmentation therapy. The CTG will be harvested using full thickness incisions that include the periosteum and will be closed using suture and coating the incision line with a tissue adhesive. No covering stents or packs should be employed. The CTG will be sling sutured in place and the flap secured using a double sling suturing technique. | Procedure or surgery | Control |
| Soft tissue flap + Geistlich Fibro-Gide®The treatment site is accessed using a full thickness flap extending at least 1 full tooth mesial and distal, vertical releasing incisions may be used to obtain flap release for full coverage of the treatment site and matrix without compression. Geistlich Fibro-Gide® is cut to shape to the treatment site and placed dry into the site. The flap is secured using a double sling suturing technique. | Device | Test |
Primary outcome
Change in gingival soft tissue volume assessed with 3D scanning
Time frame: 6 months post treatment
Change in gingival soft tissue volume compared to baseline [Time Frame 6 months post-treatment] Measured by digital contour scan
6 secondary outcomes
All Adverse Events, serious and non serious
Time frame: Day 0, after 2, 4, 12weeks, 6 Months, 1,3,5 Years
Post-OP Patient Reported Outcome Questionnaire
Time frame: 6 Months, 1,3,5 Years
Concomitant medication
Time frame: 2,4,12 weeks, 6 months, 1,3,5 Years
Change in gingival soft tissue contour
Time frame: 3 months, 1,3, 5 Years
General Periodontal Examination (GPE)
Time frame: 4, 12 weeks, 6 Months, 1,3,5 Years
Pink esthetic score (PES)
Time frame: 6 Months, 1,3,5 Years
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 9 Sep 2026.
- Derived from this study: PubMed 38071454Clem DS, McClain PK, McGuire MK, Richardson CR, Santarelli GA, Schallhorn RA, Scheyer ET, Gunsolley JC, Morelli T. Harvest graft substitute for soft tissue volume augmentation around existing implants: A randomized, controlled and blinded multicenter trial. J Periodontol. 2024 Aug;95(8):740-748. doi: 10.1002/JPER.23-0305. Epub 2023 Dec 9.
- 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.
Donald S Clem III, DDS principal investigator
Regenative Solutions
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soft tissue flap + Connective Tissue Graft and Soft tissue flap + Geistlich Fibro-Gide® in people with Soft Tissue Defect, run by Geistlich Pharma AG at 5 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 7 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 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 gingival soft tissue volume assessed with 3D scanning (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?
On the ClinicalTrials.gov record for NCT04703738, which also lists 1 linked publication.
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 9 Sep 2026.