Bone ResorptionNCT05537545
Timing of Soft Tissue Grafting Following Immediate Implant Placement
A study testing Soft tissue grafting in people with Bone Resorption, run by University Ghent at 1 site in Belgium.
Trial summary
Patients undergoing single immediate implant placement (IIP) in the premaxilla will be invited to participate in this randomized controlled trial (RCT). Prior to surgery, a small- field low-dose cone beam computed tomography (CBCT) is taken to verify the integrity of the facial bone wall and an adequate amount of… Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bone Resorption
- What is being tested?
- Soft tissue grafting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Aug 2022to 1 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 20 years old
- Good oral hygiene defined as full-mouth plaque score ≤ 25% (O'Leary et al. 1972)
- Presence of an incisor, cuspid or premolar in the maxilla that needs to be extracted for any reason with at least one neighboring tooth present
- At least 3 mm bone available at the apical or palatal aspect of the alveolus as assessed on CBCT to ensure primary implant stability
- Intact buccal bone wall at the time of extraction
- Written informed consent
Who cannot join
- Pregnancy
- Systemic diseases
- Smoking
- Suppuration
- > 1 mm gingival asymmetry between the failing and contralateral tooth
- Untreated periodontal disease; untreated caries lesions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lorenz Seyssens, Phd candidate contact
Belgium1 site, 1 recruiting
- Recruiting
Ghent University
Ghent, Oost-Vlaanderen, 9000
Jan Cosyn, Professor, jan.cosyn@ugent.be
Lorenz Seyssens, Phd candidate, lorenz.seyssens@ugent.be
About this study
Official title: A Randomized Controlled Trial on the Timing of Soft Tissue Grafting Following Immediate Implant Placement
Patients undergoing single immediate implant placement (IIP) in the premaxilla will be invited to participate in this randomized controlled trial (RCT). Prior to surgery, a small- field low-dose cone beam computed tomography (CBCT) is taken to verify the integrity of the facial bone wall and an adequate amount of apical and palatal bone availability for implant anchorage.
In all of the patients, a connective tissue graft (CTG) will be harvested and inserted into the buccal mucosa to increase soft tissue thickness around the immediately installed implant. However, included patients will be randomly allocated to either receive the CTG immediately after implant installation (Immediate soft tissue grafting, ISG = control group) or 3 months after implant installation (Delayed soft tissue grafting, DSG = test group).
Read more
Forty sealed envelopes are prepared for that purpose, of which 20 are internally labeled as "DSG" and 20 as "ISG". Following IIP, a sealed envelope will be opened to reveal the treatment concept In both groups, a cutting implant is installed in an optimal 3D position. Socket grafting is performed with deproteinized bovine bone mineral to limit buccal bone resorption and to optimize soft tissue stability.
In the ISG group, a pouch is made in the buccal mucosa using microsurgical instruments. Thereupon, a free gingival graft is harvested from the palatal mucosa in the premolar area and de-epithelialized to arrive at a CTG of about 1 mm thickness. Height and length are tailored to the dimensions of the site. Then, the CTG is brought into the pouch and fixed with two single sutures onto the buccal mucosa. Finally, a healing abutment is installed, which is replaced by a provisional implant crown 2 days later.
In the DSG group, implant placement, socket grafting and installation of a provisional implant crown occur as described above. In contrast, a buccal pouch is performed 3 months after implant installation. Graft harvesting, adaptation and fixation are performed as described above.
A small-field low-dose CBCT is taken at the 1-year and 5-year follow-up in order to measure buccal bone resorption as compared to the baseline dimensions in designated software.
Read the detailed description
Patients with a single failing tooth in the anterior maxilla will be included after a clinical examination and evaluation of a small-field low-dose CBCT. An intra-oral scan will be taken in order to make a surgical guide. A cutting implant with variable thread design (BLX, Straumann) will be installed using the surgical guide in order to sufficient primary implant stability.
Thereafter, the gap between the implant surface and buccal bone wall is filled with deproteinized bovine bone mineral (Bio-Oss, Gheistlich Pharma).
At this point, a closed envelope is opened and the patient gets assigned to either ISG or DSG group.
In the immediate soft tissue grafting group, a de-epithelialized free gingival graft was inserted in a buccal pouch to augment the buccal soft tissues. The graft was fixed with single sutures (Seralon 6/0, Serag Wiessner, Naila, Germany).
In the delayed soft tissue grafting group, the same procedure was performed 3 months after implant placement.
In both groups, patients received an immediate, screw-retained temporary crown. Restorations were installed within the first 48h after implant placement.
Sutures were removed 1 week after soft tissue grafting.
- Conditions
- Bone Resorption
- Being tested
- Soft tissue grafting
- Keywords
- dental implant, single tooth, immediate, connective tissue graft
- Medical subject headings
- Bone Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soft tissue graftingProcedure or surgery
A pouch is made in the buccal mucosa using microsurgical instruments. Thereupon, a free gingival graft is harvested from the palatal mucosa in the premolar area and de-epithelialized to arrive at a CTG of about 1 mm thickness. Height and length are tailored to the dimensions of the site. Then, the CTG is brought into the pouch and fixed with two single sutures (Seralon 6/0, Serag Wiessner, Naila, Germany) onto the buccal mucosa.
| Study group | Role | What they receive |
|---|---|---|
| Immediate soft tissue grafting | Active comparator | A connective tissue graft is immediately harvested and inserted in the buccal mucosa at the moment of implant placement Receives: Procedure: Soft tissue grafting |
| Delayed soft tissue grafting | Experimental | Three months after implant placement, a connective tissue graft is harvested and inserted in the buccal mucosa Receives: Procedure: Soft tissue grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Buccal bone resorption (mm)
Changes in buccal bone dimension as measured on superimposed CBCT slides
Measured: 1-, 5-year
Secondary outcomes (8)
Changes in buccal soft tissue profile (mm)
Changes in buccal soft tissue profile as measured on superimposed digital surface models. An intra-oral scan is taken prior to implant surgery and at 1- and 5- year follow up. On the obtained digital models, an area of interest (AOI) at the buccal aspect was drawn for each site. The AOI extends from 0.5 mm below the soft tissue margin to 4 mm more apical. In mesio-distal dimension, the AOI reaches from the mesial to the distal line angle. The AOI may vary between sites because of individual anatomic differences but must be kept constant in each site across time points. A volumetric change (mm3) was calculated by designated software within the AOI and divided by the AOI surface (mm2). This results in the mean change in buccal soft tissue profile (mm).
Measured: 1-, 5-year
Changes in midfacial soft tissue level (mm)
Changes in buccal mucosal margin position as measured on superimposed digital surface models
Measured: 1-, 5-year
Pink Esthetic Score
Pink Esthetic score as defined by Fürhauser et al., 2005. Within this scale, 7 variables are evaluated ( mesial papilla, distal papilla, soft-tissue level, soft-tissue contour, alveolar process deficiency, soft-tissue color and texture) using a 0-1-2 scoring system, 0 being the lowest, 2 being the highest value, the maximum achievable PES was 14. A 0 relates to the least esthetic result, while a 14 relates to a perfect outcome for all parameters.
Measured: 1-year
Mucosal Scarring Index
Mucosal Scarring Index as defined by Wessels et al., 2019. Within this scale, 5 parameters are assessed (width, height/contour, color, suture marks, and overall appearance) using a 0-1-2 scoring system. The MSI score may range from 0 (no scar) to 10 (most extreme scar).
Measured: 1-year
Marginal bone level changes (mm)
Changes in the distance from the implant-abutment interface to the first bone-to-implant contact (so-called marginal bone level) at the mesial and distal aspect of each implant as measured on 2D intra-oral radiographs
Measured: 1-,5-year
Probing depth (mm)
Measured with a periodontal probe at four locations (mesio-buccal, buccal, disto-buccal and oral) around the implant at 1- and 5-year follow-up. Measurements are rounded up to the nearest 0.5 mm. A mean value is calculated per implant.
Measured: 1-,5-year
Plaque (%)
Presence of plaque at four locations (mesio-buccal, buccal, disto-buccal and oral) around the implant. Each location is scored 0 or 1
Measured: 1-,5-year
Bleeding on probing (%)
Presence of bleeding on probing at four locations (mesio-buccal, buccal, disto-buccal and oral) around the implant. Each location is scored 0 or 1
Measured: 1-,5-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start1 Aug 2022
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Bone ResorptionStudies of the same condition, open and under way.
- More trials run by University GhentThe 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
- Randomized controlled trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05537545
- Sponsor's protocol ID
- ONZ-2022-0258
- Status last verified
- Oct 2023
- First submitted
- 1 Sep 2022
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
O'Leary TJ, Drake RB, Naylor JE. The plaque control record. J Periodontol. 1972 Jan;43(1):38. doi: 10.1902/jop.1972.43.1.38. No abstract available.
PubMed 4500182Furhauser R, Florescu D, Benesch T, Haas R, Mailath G, Watzek G. Evaluation of soft tissue around single-tooth implant crowns: the pink esthetic score. Clin Oral Implants Res. 2005 Dec;16(6):639-44. doi: 10.1111/j.1600-0501.2005.01193.x.
PubMed 16307569Zuiderveld EG, van Nimwegen WG, Meijer HJA, Jung RE, Muhlemann S, Vissink A, Raghoebar GM. Effect of connective tissue grafting on buccal bone changes based on cone beam computed tomography scans in the esthetic zone of single immediate implants: A 1-year randomized controlled trial. J Periodontol. 2021 Apr;92(4):553-561. doi: 10.1002/JPER.20-0217. Epub 2020 Sep 11.
PubMed 32918332Seyssens L, Eghbali A, Christiaens V, De Bruyckere T, Doornewaard R, Cosyn J. A one-year prospective study on alveolar ridge preservation using collagen-enriched deproteinized bovine bone mineral and saddle connective tissue graft: A cone beam computed tomography analysis. Clin Implant Dent Relat Res. 2019 Oct;21(5):853-861. doi: 10.1111/cid.12843. Epub 2019 Aug 28.
PubMed 31456345Wessels R, De Roose S, De Bruyckere T, Eghbali A, Jacquet W, De Rouck T, Cosyn J. The Mucosal Scarring Index: reliability of a new composite index for assessing scarring following oral surgery. Clin Oral Investig. 2019 Mar;23(3):1209-1215. doi: 10.1007/s00784-018-2535-6. Epub 2018 Jul 3.
PubMed 29971512Struys T, Christiaens V, De Bruyckere T, Pitman J, Van Hove PJ, Cosyn J. A Randomized Controlled Trial on the Timing of Soft Tissue Augmentation in Immediate Implant Placement: Soft Tissue Changes and Esthetic Outcome. Clin Implant Dent Relat Res. 2025 Feb;27(1):e70013. doi: 10.1111/cid.70013.
PubMed 39980395Cosyn J, Struys T, Van Hove PJ, De Buyser S, De Bruyckere T. A Randomized Controlled Trial on the Timing of Soft-Tissue Augmentation in Immediate Implant Placement: Hard-Tissue Changes and Clinical Outcome. J Clin Periodontol. 2024 Nov;51(11):1534-1544. doi: 10.1111/jcpe.14060. Epub 2024 Sep 1.
PubMed 39218777
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial on the Timing of Soft Tissue Grafting Following Immediate Implant Placement
- ClinicalTrials.gov ID
- NCT05537545
- Acronym / sponsor ID
- ONZ-2022-0258
- Conditions
- Bone Resorption
- Keywords
- dental implant, single tooth, immediate, connective tissue graft
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 13 Sep 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.
Patients undergoing single immediate implant placement (IIP) in the premaxilla will be invited to participate in this randomized controlled trial (RCT). Prior to surgery, a small- field low-dose cone beam computed tomography (CBCT) is taken to verify the integrity of the facial bone wall and an adequate amount of apical and palatal bone availability for implant anchorage.
In all of the patients, a connective tissue graft (CTG) will be harvested and inserted into the buccal mucosa to increase soft tissue thickness around the immediately installed implant. However, included patients will be randomly allocated to either receive the CTG immediately after implant installation (Immediate soft tissue grafting, ISG = control group) or 3 months after implant installation (Delayed soft tissue grafting, DSG = test group).
Forty sealed envelopes are prepared for that purpose, of which 20 are internally labeled as "DSG" and 20 as "ISG". Following IIP, a sealed envelope will be opened to reveal the treatment concept In both groups, a cutting implant is installed in an optimal 3D position. Socket grafting is performed with deproteinized bovine bone mineral to limit buccal bone resorption and to optimize soft tissue stability.
In the ISG group, a pouch is made in the buccal mucosa using microsurgical instruments. Thereupon, a free gingival graft is harvested from the palatal mucosa in the premolar area and de-epithelialized to arrive at a CTG of about 1 mm thickness. Height and length are tailored to the dimensions of the site. Then, the CTG is brought into the pouch and fixed with two single sutures onto the buccal mucosa. Finally, a healing abutment is installed, which is replaced by a provisional implant crown 2 days later.
In the DSG group, implant placement, socket grafting and installation of a provisional implant crown occur as described above. In contrast, a buccal pouch is performed 3 months after implant installation. Graft harvesting, adaptation and fixation are performed as described above.
A small-field low-dose CBCT is taken at the 1-year and 5-year follow-up in order to measure buccal bone resorption as compared to the baseline dimensions in designated software.
Detailed description
Patients with a single failing tooth in the anterior maxilla will be included after a clinical examination and evaluation of a small-field low-dose CBCT. An intra-oral scan will be taken in order to make a surgical guide. A cutting implant with variable thread design (BLX, Straumann) will be installed using the surgical guide in order to sufficient primary implant stability.
Thereafter, the gap between the implant surface and buccal bone wall is filled with deproteinized bovine bone mineral (Bio-Oss, Gheistlich Pharma).
At this point, a closed envelope is opened and the patient gets assigned to either ISG or DSG group.
In the immediate soft tissue grafting group, a de-epithelialized free gingival graft was inserted in a buccal pouch to augment the buccal soft tissues. The graft was fixed with single sutures (Seralon 6/0, Serag Wiessner, Naila, Germany).
In the delayed soft tissue grafting group, the same procedure was performed 3 months after implant placement.
In both groups, patients received an immediate, screw-retained temporary crown. Restorations were installed within the first 48h after implant placement.
Sutures were removed 1 week after soft tissue grafting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Immediate soft tissue grafting | Active comparator | Procedure: Soft tissue graftingA connective tissue graft is immediately harvested and inserted in the buccal mucosa at the moment of implant placement |
| Delayed soft tissue grafting | Experimental | Procedure: Soft tissue graftingThree months after implant placement, a connective tissue graft is harvested and inserted in the buccal mucosa |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- At least 20 years old
- Good oral hygiene defined as full-mouth plaque score ≤ 25% (O'Leary et al. 1972)
- Presence of an incisor, cuspid or premolar in the maxilla that needs to be extracted for any reason with at least one neighboring tooth present
- At least 3 mm bone available at the apical or palatal aspect of the alveolus as assessed on CBCT to ensure primary implant stability
- Intact buccal bone wall at the time of extraction
Key exclusion criteria (6 listed)
- Pregnancy
- Systemic diseases
- Smoking
- Suppuration
- > 1 mm gingival asymmetry between the failing and contralateral tooth
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 graftingA pouch is made in the buccal mucosa using microsurgical instruments. Thereupon, a free gingival graft is harvested from the palatal mucosa in the premolar area and de-epithelialized to arrive at a CTG of about 1 mm thickness. Height and length are tailored to the dimensions of the site. Then, the CTG is brought into the pouch and fixed with two single sutures (Seralon 6/0, Serag Wiessner, Naila, Germany) onto the buccal mucosa. | Procedure or surgery | Delayed soft tissue grafting, Immediate soft tissue grafting |
Primary outcome
Buccal bone resorption (mm)
Time frame: 1-, 5-year
Changes in buccal bone dimension as measured on superimposed CBCT slides
8 secondary outcomes
Changes in buccal soft tissue profile (mm)
Time frame: 1-, 5-year
Changes in midfacial soft tissue level (mm)
Time frame: 1-, 5-year
Pink Esthetic Score
Time frame: 1-year
Mucosal Scarring Index
Time frame: 1-year
Marginal bone level changes (mm)
Time frame: 1-,5-year
Probing depth (mm)
Time frame: 1-,5-year
Plaque (%)
Time frame: 1-,5-year
Bleeding on probing (%)
Time frame: 1-,5-year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- Background: PubMed 4500182O'Leary TJ, Drake RB, Naylor JE. The plaque control record. J Periodontol. 1972 Jan;43(1):38. doi: 10.1902/jop.1972.43.1.38. No abstract available.
- Background: PubMed 16307569Furhauser R, Florescu D, Benesch T, Haas R, Mailath G, Watzek G. Evaluation of soft tissue around single-tooth implant crowns: the pink esthetic score. Clin Oral Implants Res. 2005 Dec;16(6):639-44. doi: 10.1111/j.1600-0501.2005.01193.x.
- Background: PubMed 32918332Zuiderveld EG, van Nimwegen WG, Meijer HJA, Jung RE, Muhlemann S, Vissink A, Raghoebar GM. Effect of connective tissue grafting on buccal bone changes based on cone beam computed tomography scans in the esthetic zone of single immediate implants: A 1-year randomized controlled trial. J Periodontol. 2021 Apr;92(4):553-561. doi: 10.1002/JPER.20-0217. Epub 2020 Sep 11.
- Background: PubMed 31456345Seyssens L, Eghbali A, Christiaens V, De Bruyckere T, Doornewaard R, Cosyn J. A one-year prospective study on alveolar ridge preservation using collagen-enriched deproteinized bovine bone mineral and saddle connective tissue graft: A cone beam computed tomography analysis. Clin Implant Dent Relat Res. 2019 Oct;21(5):853-861. doi: 10.1111/cid.12843. Epub 2019 Aug 28.
- Background: PubMed 29971512Wessels R, De Roose S, De Bruyckere T, Eghbali A, Jacquet W, De Rouck T, Cosyn J. The Mucosal Scarring Index: reliability of a new composite index for assessing scarring following oral surgery. Clin Oral Investig. 2019 Mar;23(3):1209-1215. doi: 10.1007/s00784-018-2535-6. Epub 2018 Jul 3.
- Derived from this study: PubMed 39980395Struys T, Christiaens V, De Bruyckere T, Pitman J, Van Hove PJ, Cosyn J. A Randomized Controlled Trial on the Timing of Soft Tissue Augmentation in Immediate Implant Placement: Soft Tissue Changes and Esthetic Outcome. Clin Implant Dent Relat Res. 2025 Feb;27(1):e70013. doi: 10.1111/cid.70013.
- Derived from this study: PubMed 39218777Cosyn J, Struys T, Van Hove PJ, De Buyser S, De Bruyckere T. A Randomized Controlled Trial on the Timing of Soft-Tissue Augmentation in Immediate Implant Placement: Hard-Tissue Changes and Clinical Outcome. J Clin Periodontol. 2024 Nov;51(11):1534-1544. doi: 10.1111/jcpe.14060. Epub 2024 Sep 1.
- 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.
Lorenz Seyssens, Phd candidate contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soft tissue grafting in people with Bone Resorption, run by University Ghent at 1 site in Belgium.
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 6 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: looking for participants now, as of the sponsor's last update on 3 Oct 2023. 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 Belgium. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jan Cosyn, Professor (+3293324000, jan.cosyn@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Buccal bone resorption (mm) (time frame: 1-, 5-year). 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 NCT05537545, which also lists 7 linked publications.
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 3 Oct 2023.