Tooth LossGeistlichNCT04265768
Soft Tissue Changes Around Dental Implants
A study testing Soft tissue augmentation surgery with CTG, Soft tissue augmentation surgery with Fibro-Gide and No soft tissue augmentation in people with Tooth Loss and Dental Diseases, run by Queen Mary University of London at 2 sites in United Kingdom.
Trial summary
This study aims to characterize the healing pattern following soft tissue augmentation procedure concomitant to implant placement. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Tooth Loss, Dental Diseases, Wound Heal
- What is being tested?
- Soft tissue augmentation surgery with CTG, Soft tissue augmentation surgery with Fibro-Gide and No soft tissue augmentation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 21 Jun 2021to 24 Feb 2025
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 20 and 80 years.
- Good medical and psychological health.
- Absence of untreated caries lesions and untreated/uncontrolled periodontal disease. If patients require periodontal treatment (non-surgical and/or surgical), this has to be arranged outside the study protocol and completed at least 30 days prior to the enrolment.
- Need of a single-tooth replacement in the aesthetic (incisor, canine or premolar) region.
- Presence of adequate bone for implant placement without need for significant bone regeneration. In particular, the patients should have a bucco-palatal residual alveolar width of at least 6 mm at the central and crestal aspect of the single tooth gap to ensure complete embedding of an implant by bone (De Bruyckere et al., 2018).
- A residual alveolar height >8 mm, enough inter-arch space for a crown and a minimum distance of 6 mm from the adjacent teeth.
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- The width and height will be confirmed after x-ray examination in Visit 1 (or extra visit). Cases of small apical fenestration (≤ 25% of implant length) after implant placement will not be excluded, but will be treated according to the GBR principle (collagen membrane associated with a deproteinized bovine bone graft) to re-establish the bone contour and without over contouring.
- At least 8 weeks of post-extraction socket healing had occurred in the edentulous site.
- Willingness to sign the informed consent form.
Who cannot join
- Self-reported pregnancy and lactation.
- Any known systemic disease affecting bone metabolism (e.g. Cushing's syndrome, crohn's disease, rheumatoid arthritis, osteoporosis, diabetes type I and uncontrolled diabetes type II), systemic infections or recent surgical procedures within 30 days of study initiation.
- Chronic treatment (i.e., 2 weeks or more) with any medication known to affect oral status (e.g., phenytoin, dihydropyridine, calcium antagonists and cyclosporine) or bone metabolism (e.g. bisphosphonates, hormone replacement therapy, immunosuppressants) within 1 month before baseline visit.
- HIV or viral hepatitis.
- Physical handicaps that would interfere with the ability to perform adequate oral hygiene.
- Self-reported alcoholism or chronic drug abuse.
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- Heavy smokers (>10/cigarettes per day).
- Patients suffering from a known psychological disorder or with limited mental capacity or language skills such that study information could not be understood, informed consent could be obtained or simple instructions could be followed.
- Full-mouth bleeding (BOP) and plaque (PI) scores >30% or sites with periodontal pocket depth >5 mm at the completion of the pre-treatment phase.
- Very thin or very thick biotypes that according to the clinician's judgement would either risk to have complications or would not benefit from receiving a graft.
- <2 mm KT buccally (from the mucogingival junction to the coronal aspect of the crestal soft tissue).
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Barts and The London Dental Hospital
London, E1 2AD
Centre for Oral Clinical Research (COCR)
London, E1 2AD
About this study
Official title: Dimensional Soft Tissue Changes Around Dental Implants Following the Use of a Collagen Matrix or a Connective Tissue Graft. A Pilot Study
This study aims to characterize the healing pattern following soft tissue augmentation procedure concomitant to implant placement.
Read the detailed description
This study will characterize, for the first time, the healing pattern of soft tissues around dental implants in case of soft tissue augmentation and in comparison, to normal healing.
An innovative and comprehensive geometric/thermal imaging analysis will be employed that is non-contact and non-invasive to patients and will allow to characterize the healing process in a 2D-3D dimensional and volumetric way.
This approach, combined with LSCI and clinical and radiographic outcomes, will provide new data on the biology and critical phases of soft tissue healing around implants, as well as on the stability and aesthetics of the peri-implant tissues with different grafts.
Patient-reported outcome measurements (PROMs) will also be used to assess the level of pain and discomfort associated with soft tissue augmentation procedures.
- Conditions
- Tooth Loss, Dental Diseases, Wound Heal
- Being tested
- Soft tissue augmentation surgery with CTG, Soft tissue augmentation surgery with Fibro-Gide, No soft tissue augmentation
- Keywords
- soft tissue regeneration, soft tissue graft, dental implant, imaging
- Medical subject headings
- Tooth Loss, Stomatognathic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soft tissue augmentation surgery with CTGProcedure or surgery
An epithelial-connective tissue graft of approximately 2-3 mm of thickness and adequate length will be taken from the palate or retromolar region of the patient and de-epithelialized with a scalpel (ideally a thickness of 1.5-2.0mm).
The connective tissue graft (CTG) obtained will then be positioned buccally to the dental implant and sutured to the internal side of the flap so to provide soft tissue bulk at the level of the neck of the implant and simulate a root prominence for the missing tooth.
Soft tissue augmentation surgery with Fibro-GideProcedure or surgery
Fibro-Gide will be used to obtain buccal soft tissue augmentation. Fibro-Gide will be trimmed with a scalpel and adjusted in size and thickness to better adapt to the area buccal to the implant. In particular, the graft will be shaped in order to obtain a graft of approximately 2-3 mm of thickness and adequate length. Fibro-Gide will then be sutured to the inner side of the buccal flap, before repositioning the flap and suturing it in a tension-free way.
No soft tissue augmentationProcedure or surgery
During implant placement surgery, no soft tissue augmentation will be performed
| Study group | Role | What they receive |
|---|---|---|
| No Soft tissue augmentation surgery | Placebo comparator | No soft tissue augmentation concomitant to implant placement. Negative control group. Receives: Procedure: No soft tissue augmentation |
| Soft tissue augmentation surgery with Fibro-Gide | Experimental | Soft tissue augmentation concomitant to implant placement with a porcine, volume-stable cross-linked collagen matrix (Fibro-Gide, Geistlich Pharma AG, Wolhusen, Switzerland).
Test group. Receives: Procedure: Soft tissue augmentation surgery with Fibro-Gide |
| Soft tissue augmentation surgery with patient's CTG | Active comparator | Soft tissue augmentation concomitant to implant placement with a connective tissue graft (CTG) taken from the patient's palate or retromolar area.
Positive control group. Receives: Procedure: Soft tissue augmentation surgery with CTG |
What is being measured
The primary outcome is the main question the study is designed to answer.
3D intra-oral volume changes in mucosal soft tissue following augmentation
Those changes will be assessed by capturing 3D intra-oral scans at the different time-points.
Measured: Immediately after implant placement.
3D intra-oral volume changes in mucosal soft tissue following augmentation
Those changes will be assessed by capturing 3D intra-oral scans at the different time-points.
Measured: 7, 14 and 30 Days post implant placement
3D intra-oral volume changes in mucosal soft tissue following augmentation
Those changes will be assessed by capturing 3D intra-oral scans at the different time-points.
Measured: 12 weeks and 16 weeks post- implant loading.
3D intra-oral volume changes in mucosal soft tissue following augmentation
Those changes will be assessed by capturing 3D intra-oral scans at the different time-points.
Measured: 12 month post- implant loading.
Secondary outcomes (10)
Changes in gingival thickness
Changes in gingival thickness from the time of implant placement (with or without graft) and 12 weeks after implant placement assessed by a caliper
Measured: implant placement to 12 weeks after implant placement
3D extra-oral volumetric changes
3D extra-oral morphometric changes assessed with a facial scanner
Measured: baseline, immediately after implant placement, 7, 14 and 30 days after implant placement
2D-3D intra-oral thermal changes
2D-3D intra-oral thermal changes using an infrared, contact-free, thermal camera
Measured: baseline to 1, 3, 7, 14 and 30 days after implant placement
changes in vascularisation
Changes in revascularization in the area of the implant surgery with laser speckle contrast imaging
Measured: before and immediately after implant placement, and at post-operative days 1, 3, 7, 14, and 30
soft tissue aesthetics
Papilla Fill Index and Pink Aesthetic Score
Measured: At implant loading and at 12 months after loading.
changes in height of keratinised tissue
changes in height of keratinised tissue measured with a probe
Measured: baseline to 30 days, 12 weeks and 16 weeks after implant placement and 12 months post loading
Patients' reported outcomes (PROMS) in oral impact on Daily Performances (OIDP) questionnaire (OIDP)
The OIPD is a well validated and frequently used PROMs in studies of oral health. It is a composite measure of the impacts of oral health on the quality of life of people. The OIDP focuses on the impact of oral health on the quality of life of people. The OIDP focuses on the impact that the conditions of the teeth and social wellbeing of the person. More specifically, it assesses the impact of oral conditions on basic daily life activities and behaviours (eating, speaking, cleaning teeth, going out, relaxing, smiling, major work or role, emotional stability, social contact). For each performance, both the frequency and severity of oral impacts are assessed. The overall OIDP score ranges from 0 to 100, with higher scores indicating worse quality of life.
Measured: At basline, 3 months (visit2, 3 and 4), 1 week from visit 2, 2 weeks form visit 2, 1 month from visit 2.
PROMs based on the evaluation of global changes in quality of life
Global ratings on health and quality of life will be provided through two methods:
- The Visual Analogue Scale (VAS) included in the EQ5D questionnaire.
- Through the following question: 'how would you rate the quality of your life'?
The response will be scored on a six-point scale as:
- Excellent
- Very good
- Good
- Fair
- Poor
- Very poor
Measured: At basline, 3 months (visit2, 3 and 4), 1 week from visit 2, 2 weeks form visit 2, 1 month from visit 2.
PROMs based on the evaluation of patient's perception about therapy
The extent of discomfort and/or pain experienced will be evaluated using a 100-mm horizontal visual analogue scale (VAS). The anchors for each end of the scales will be designated as none and extreme. Patients will be also instructed to quantify the analgesic medication taken. In addition, the extent of discomfort, root hypersensitivity, oedema, hematoma, high fever and interference in daily activities during the first post-therapy week will be evaluated in the same way.
Measured: At basline, 3 months (visit2, 3 and 4), 1 week from visit 2, 2 weeks form visit 2, 1 month from visit 2.
Post-operative swelling and oedema
A series of subtracted images from the baseline will accurately identify the area and magnitude of the swelling, changes in facial shape, volume and temperature to monitor/quantify the healing. For every patient, a person specific template of postoperative facial swelling/oedema pattern will be created for sequential swelling/thermal changes or oedema volume measurements that will be applied on a unique alignment of the patient's specific consecutive imaging surfaces (self-defined positioning based on patients facial features).
Measured: At basline, 3 months (visit2, 3 and 4), 1 week from visit 2, 2 weeks form visit 2, 1 month from visit 2.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start21 Jun 2021
- Primary completion24 Feb 2025
- Study completion24 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth LossStudies 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
- The study will includes 3 groups randomised in parallel.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Collaborators
- Geistlich Pharma AG
- Responsible party
- Sponsor
- Investigators
- Nikos Donos, PhD, Principal investigator, Barts & The London School of Medicine & Dentistry, QMUL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04265768
- Sponsor's protocol ID
- IRAS 268553
- Acronym
- Geistlich
- Status last verified
- Jun 2025
- First submitted
- 23 Jan 2020
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dimensional Soft Tissue Changes Around Dental Implants Following the Use of a Collagen Matrix or a Connective Tissue Graft. A Pilot Study
- ClinicalTrials.gov ID
- NCT04265768
- Acronym / sponsor ID
- Geistlich / IRAS 268553
- Conditions
- Tooth Loss, Dental Diseases, Wound Heal
- Keywords
- soft tissue regeneration, soft tissue graft, dental implant, imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Collaborators
- Geistlich Pharma AG
- Study start
- 21 Jun 2021 (actual)
- Primary completion
- 24 Feb 2025 (actual)
- Study completion
- 24 Feb 2025 (actual)
- First posted
- 12 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 study aims to characterize the healing pattern following soft tissue augmentation procedure concomitant to implant placement.
Detailed description
This study will characterize, for the first time, the healing pattern of soft tissues around dental implants in case of soft tissue augmentation and in comparison, to normal healing.
An innovative and comprehensive geometric/thermal imaging analysis will be employed that is non-contact and non-invasive to patients and will allow to characterize the healing process in a 2D-3D dimensional and volumetric way.
This approach, combined with LSCI and clinical and radiographic outcomes, will provide new data on the biology and critical phases of soft tissue healing around implants, as well as on the stability and aesthetics of the peri-implant tissues with different grafts.
Patient-reported outcome measurements (PROMs) will also be used to assess the level of pain and discomfort associated with soft tissue augmentation procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- The study will includes 3 groups randomised in parallel.
| Arm | Type | Receives |
|---|---|---|
| No Soft tissue augmentation surgery | Placebo comparator | Procedure: No soft tissue augmentationNo soft tissue augmentation concomitant to implant placement. Negative control group. |
| Soft tissue augmentation surgery with Fibro-Gide | Experimental | Procedure: Soft tissue augmentation surgery with Fibro-GideSoft tissue augmentation concomitant to implant placement with a porcine, volume-stable cross-linked collagen matrix (Fibro-Gide, Geistlich Pharma AG, Wolhusen, Switzerland). Test group. |
| Soft tissue augmentation surgery with patient's CTG | Active comparator | Procedure: Soft tissue augmentation surgery with CTGSoft tissue augmentation concomitant to implant placement with a connective tissue graft (CTG) taken from the patient's palate or retromolar area. Positive control group. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age between 20 and 80 years.
- Good medical and psychological health.
- Absence of untreated caries lesions and untreated/uncontrolled periodontal disease. If patients require periodontal treatment (non-surgical and/or surgical), this has to be arranged outside the study protocol and completed at least 30 days prior to the enrolment.
- Need of a single-tooth replacement in the aesthetic (incisor, canine or premolar) region.
- Presence of adequate bone for implant placement without need for significant bone regeneration. In particular, the patients should have a bucco-palatal residual alveolar width of at least 6 mm at the central and crestal aspect of the single tooth gap to ensure complete embedding of an implant by bone (De Bruyckere et al., 2018).
Key exclusion criteria (11 listed)
- Self-reported pregnancy and lactation.
- Any known systemic disease affecting bone metabolism (e.g. Cushing's syndrome, crohn's disease, rheumatoid arthritis, osteoporosis, diabetes type I and uncontrolled diabetes type II), systemic infections or recent surgical procedures within 30 days of study initiation.
- Chronic treatment (i.e., 2 weeks or more) with any medication known to affect oral status (e.g., phenytoin, dihydropyridine, calcium antagonists and cyclosporine) or bone metabolism (e.g. bisphosphonates, hormone replacement therapy, immunosuppressants) within 1 month before baseline visit.
- HIV or viral hepatitis.
- Physical handicaps that would interfere with the ability to perform adequate oral hygiene.
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 augmentation surgery with CTGAn epithelial-connective tissue graft of approximately 2-3 mm of thickness and adequate length will be taken from the palate or retromolar region of the patient and de-epithelialized with a scalpel (ideally a thickness of 1.5-2.0mm). The connective tissue graft (CTG) obtained will then be positioned buccally to the dental implant and sutured to the internal side of the flap so to provide soft tissue bulk at the level of the neck of the implant and simulate a root prominence for the missing tooth. | Procedure or surgery | Soft tissue augmentation surgery with patient's CTG |
| Soft tissue augmentation surgery with Fibro-GideFibro-Gide will be used to obtain buccal soft tissue augmentation. Fibro-Gide will be trimmed with a scalpel and adjusted in size and thickness to better adapt to the area buccal to the implant. In particular, the graft will be shaped in order to obtain a graft of approximately 2-3 mm of thickness and adequate length. Fibro-Gide will then be sutured to the inner side of the buccal flap, before repositioning the flap and suturing it in a tension-free way. | Procedure or surgery | Soft tissue augmentation surgery with Fibro-Gide |
| No soft tissue augmentationDuring implant placement surgery, no soft tissue augmentation will be performed | Procedure or surgery | No Soft tissue augmentation surgery |
Primary outcome
3D intra-oral volume changes in mucosal soft tissue following augmentation
Time frame: Immediately after implant placement.
Those changes will be assessed by capturing 3D intra-oral scans at the different time-points.
3D intra-oral volume changes in mucosal soft tissue following augmentation
Time frame: 7, 14 and 30 Days post implant placement
Those changes will be assessed by capturing 3D intra-oral scans at the different time-points.
3D intra-oral volume changes in mucosal soft tissue following augmentation
Time frame: 12 weeks and 16 weeks post- implant loading.
Those changes will be assessed by capturing 3D intra-oral scans at the different time-points.
3D intra-oral volume changes in mucosal soft tissue following augmentation
Time frame: 12 month post- implant loading.
Those changes will be assessed by capturing 3D intra-oral scans at the different time-points.
10 secondary outcomes
Changes in gingival thickness
Time frame: implant placement to 12 weeks after implant placement
3D extra-oral volumetric changes
Time frame: baseline, immediately after implant placement, 7, 14 and 30 days after implant placement
2D-3D intra-oral thermal changes
Time frame: baseline to 1, 3, 7, 14 and 30 days after implant placement
changes in vascularisation
Time frame: before and immediately after implant placement, and at post-operative days 1, 3, 7, 14, and 30
soft tissue aesthetics
Time frame: At implant loading and at 12 months after loading.
changes in height of keratinised tissue
Time frame: baseline to 30 days, 12 weeks and 16 weeks after implant placement and 12 months post loading
Patients' reported outcomes (PROMS) in oral impact on Daily Performances (OIDP) questionnaire (OIDP)
Time frame: At basline, 3 months (visit2, 3 and 4), 1 week from visit 2, 2 weeks form visit 2, 1 month from visit 2.
PROMs based on the evaluation of global changes in quality of life
Time frame: At basline, 3 months (visit2, 3 and 4), 1 week from visit 2, 2 weeks form visit 2, 1 month from visit 2.
PROMs based on the evaluation of patient's perception about therapy
Time frame: At basline, 3 months (visit2, 3 and 4), 1 week from visit 2, 2 weeks form visit 2, 1 month from visit 2.
Post-operative swelling and oedema
Time frame: At basline, 3 months (visit2, 3 and 4), 1 week from visit 2, 2 weeks form visit 2, 1 month from visit 2.
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 8 Jun 2025.
- 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.
Nikos Donos, PhD principal investigator
Barts & The London School of Medicine & Dentistry, QMUL
2 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 augmentation surgery with CTG, Soft tissue augmentation surgery with Fibro-Gide and No soft tissue augmentation in people with Tooth Loss and Dental Diseases, run by Queen Mary University of London at 2 sites in United Kingdom.
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 9 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 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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. Some participants in this study may receive a placebo. 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?
3D intra-oral volume changes in mucosal soft tissue following augmentation (time frame: Immediately after implant placement.). The study lists 4 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 8 Jun 2025.