Guided Bone RegenerationNCT05143242
Contour Augmentation by Means of Connective Tissue Grafting Versus Guided Bone Regeneration
A study testing Hard tissue augmentation at the buccal aspect of single implants. and Soft tissue augmentation at the buccal aspect of single implants. in people with Guided Bone Regeneration, run by University Ghent.
Trial summary
The most frequent aesthetic complication following single implant treatment seems to be a lack of buccal convexity. This 'alveolar process deficiency' is the result of buccal bone remodeling following tooth extraction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Guided Bone Regeneration
- What is being tested?
- Hard tissue augmentation at the buccal aspect of single implants. and Soft tissue augmentation at the buccal aspect of single implants.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Apr 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years old.
- Good oral hygiene defined as full-mouth plaque score ≤ 25% (O'Leary et al.1972
- Presence of a single tooth gap in the anterior maxilla (15 - 25) with both neighbouring teeth present
- Failing tooth at least 3 months earlier removed
- Class I defect at the single tooth gap as clinically assessed (buccopalatal loss of tissue with a normal apicocoronal ridge height) (Seibert, 1983)
- Signed informed consent
- Buccopalatal bone dimension 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
Who cannot join
- Systemic diseases
- Smoking
- (History of) periodontal disease
- Untreated caries lesions
- Need for horizontal bone augmentation at the time of implant placement
About this study
Official title: A Randomized Controlled Trial Comparing Guided Bone Regeneration With Connective Tissue Graft to Re-establish Buccal Convexity at Implant Sites: Three-year Results.
The most frequent aesthetic complication following single implant treatment seems to be a lack of buccal convexity. This 'alveolar process deficiency' is the result of buccal bone remodeling following tooth extraction.
A traditional approach to treat alveolar process deficiency is guided bone regeneration (GBR), however post-operative complications such as swelling, bleeding and pain are common and the aesthetic outcome may not be optimal.
Read more
An alternative to the traditional GBR approach could be soft tissue contour augmentation using a connective tissue graft (CTG) at the buccal aspect. Possible advantages over GBR include less morbidity at the implant site, a superior aesthetic outcome since there is no need for vertical releasing incisions and less costs since there are no biomaterials to be used.
The primary study objective is to compare the GBR and CTG group in terms of 2 and 3 dimensional tissue alterations, focusing on the amount of tissue gain and volume stability over time. The secondary study objectives are morbidity, overall radiographic, clinical and aesthetic outcomes.
Read the detailed description
Aim:
This study aims to compare guided bone regeneration (GBR) with connective tissue graft (CTG) to re-establish buccal convexity at single implants.
Sample size calculation:
The sample size calculation was based on the primary study outcome (BSP) and was performed in SAS Power using the Satterthwaite t-test (De Bruyckere et al., 2018). The calculation was based on finding a mean difference of at least 0.5 mm between these groups with a standard deviation of 0.5 mm. This standard deviation was arbitrarily chosen given the lack of comparative studies. Alpha was set at 0.05 and the power was set at 0.80. This resulted in the inclusion of at least 17 patients per group. To compensate for possible drop-outs, 21 patients were included in each group.
Randomization and allocation concealment:
Patients were randomly assigned to the control group (GBR) or test group (CTG). Simple randomization was performed using sealed envelopes with an equal number of envelopes for every treatment group. Group allocation was revealed just prior to surgery by the surgeon and remained concealed for the evaluating investigator during the analytical stage of the project.
Surgical procedure:
In brief, a mucoperiosteal flap was raised in the control group by means of a midcrestal incision, sulcular incisions at both neighbouring teeth and a vertical parapapillary releasing incision at the distal neighbouring tooth. Following implant installation (NobelActive®, Nobel Biocare, Gothenburg, Sweden), the buccal concavity was augmented with deproteinized bovine bone mineral (DBBM) (Bio-Oss®; 0.25 - 1mm; Geistlich Biomaterials, Wolhusen, Switserland) and a collagen membrane (Creos® xenoprotect; 15x20mm; Nobel Biocare, Gothenburg, Sweden). Following apical release of the tissues, a cover screw was installed and primary wound closure was achieved (Seralon® 5/0, Serag Weissner, Naila, Germany). Aftercare included the use of a chlorhexidine rinse, systemic antibiotics (amoxicillin 1g, two times a day) and anti-inflammatory medication (ibuprofen 600mg) as deemed necessary by the patient. After 3 months, the implant was uncovered by means of a pouch procedure. A screw-retained provisional crown was placed as described by De Rouck et al. (2008), which was replaced by the permanent restoration (Procera® on ASC® abutment, Nobel Biocare, Gothenburg, Sweden) 3 months later.
The flap design in the test group was identical to the one in the control group, yet without a vertical parapapillary releasing incision. Instead of augmenting with DBBM, an appropriately sized CTG harvested from the palatal flap or palatal mucosa in the premolar area was pulled into the envelope and immobilized (Seralon® 5/0, Serag Weissner, Naila, Germany). Non-submerged healing was respected. Aftercare and prosthetic procedures were identical in both groups. All surgical treatments and provisional restorations were performed by the same clinician. Referring dentists made permanent restorations.
- Conditions
- Guided Bone Regeneration
- Being tested
- Hard tissue augmentation at the buccal aspect of single implants., Soft tissue augmentation at the buccal aspect of single implants.
- Keywords
- connective tissue graft, dental implant, guided bone regeneration, single tooth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hard tissue augmentation at the buccal aspect of single implants.Procedure or surgery
One or two releasing incisions are made. The periosteum is released and multiple bone perforations are made in the buccal bone prior to the application of deproteinized bovine derived xenograft. A Creos® membrane (Nobel Biocare, Gothenburg, Sweden) is used to cover the occlusal part of the alveolar crest and the xenograft particles. Finally, multiple single monofilament sutures are used for primary tension-free wound closure.
Soft tissue augmentation at the buccal aspect of single implants.Procedure or surgery
A CTG is taken from the palate and transplanted to the buccal side between the alveolar bone and the buccal flap. The CTG is secured with single monofilament sutures.
| Study group | Role | What they receive |
|---|---|---|
| Guided bone regeneration: Control | Active comparator | Deproteinized bovine derived xenograft (Geistlich Bio-Oss® 0.25 - 1 mm, Geistlich Pharma AG, Wolhusen, Switzerland) Receives: Procedure: Hard tissue augmentation at the buccal aspect of single implants. |
| Connective tissue graft: Test | Active comparator | Connective tissue graft harvested from the palate Receives: Procedure: Soft tissue augmentation at the buccal aspect of single implants. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Buccal soft tissue profile
The volumetric analysis software (Swissmeda/SMOP, Zürich, Switzerland) calculated a mean dimensional change (mm3) within the AOI (area of interest) for each patient at T5 (3 years). Given the variable size in AOI (mm2) among patients, the mean dimensional change per area was transformed to a mean linear change in buccal soft tissue profile (BSP) in mm.
Measured: Year 1 and 3
Secondary outcomes (9)
Midfacial recession
Midfacial recession was registered between 6 months, 1 year and 3 years on the basis of digital surface models in STL format superimposed and imported in designated software (Swissmeda/SMOP, Zürich, Switzerland). Midfacial recession was calculated by subtracting the data from 1 and 3 years to 6 months of follow-up.
Measured: Month 6; Year 1 and 3
Buccal bone thickness
The thickness of the buccal bone was measured (in mm) at t2 (1 year) and t3 (3 years) perpendicular to the long axis of the implant. Buccal bone was measured from the implant surface to the bone-soft tissue interface at 3 levels.
Measured: Year 1 and 3
Buccal soft tissue thickness
The thickness of the soft tissues was measured (in mm) at t2 (1 year) and t3 (3 years) perpendicular to the long axis of the implant. Buccal soft tissue thickness was measured from the bone-soft tissue interface to the buccal soft tissue outline at the same levels as buccal bone thickness.
Measured: Year 1 and 3
Pink Esthetic Score
The PES awards 7 parameters: mesial papilla, distal papilla, soft tissue level, soft tissue contour, alveolar process deficiency, soft tissue colour, soft tissue texture. Each parameter is assessed with a 0-1-2 score, yielding a PES score ranging from 0 (worst aesthetic outcome) to 14 (perfect aesthetic outcome).
Measured: Year 1 and 3
Mucosal Scarring Index
The MSI is a composite index based on five parameters: width, height/contour, colour, suture marks and overall appearance. Each parameter is assessed with a 0-1-2 score, yielding an MSI score ranging from 0 (no scar) to 10 (most extreme scar).
Measured: Year 1 and 3
Marginal bone loss
Marginal bone loss was recorded at the mesial and distal aspect of each implant. The distance from the implant-abutment interface to the first bone-to-implant contact (so-called bone level) was assessed on peri-apical radiographs taken with the long-cone paralleling technique. Mesial and distal values were averaged to receive one value per implant.
Measured: Year 1 and 3
Probing depth
Probing depth was registered at four locations (mesiobuccal, buccal, distobuccal and palatal) around the implant to the nearest 0.5 mm. A mean value was calculated per implant.
Measured: Year 1 and 3
Plaque
Plaque was assessed at four locations (mesiobuccal, buccal, distobuccal and palatal) around the implant. Each location was scored 0 or 1 (the absence or presence of plaque, respectively). Plaque was expressed as a percentage.
Measured: Year 1 and 3
Bleeding on probing
Bleeding on probing was assessed at four locations (mesiobuccal, buccal, distobuccal and palatal) around the implant. Each location was scored 0 or 1 (the absence or presence of bleeding, respectively). Bleeding on probing was expressed as a percentage.
Measured: Year 1 and 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study startMar 2015
- Primary completionMar 2020
- Study completionApr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Guided Bone RegenerationStudies 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 clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05143242
- Sponsor's protocol ID
- 23-186
- Status last verified
- Dec 2021
- First submitted
- 5 Apr 2021
- Last updated
- 3 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Akcali A, Schneider D, Unlu F, Bicakci N, Kose T, Hammerle CH. Soft tissue augmentation of ridge defects in the maxillary anterior area using two different methods: a randomized controlled clinical trial. Clin Oral Implants Res. 2015 Jun;26(6):688-95. doi: 10.1111/clr.12368. Epub 2014 Apr 10.
PubMed 24720375Araujo MG, Lindhe J. Dimensional ridge alterations following tooth extraction. An experimental study in the dog. J Clin Periodontol. 2005 Feb;32(2):212-8. doi: 10.1111/j.1600-051X.2005.00642.x.
PubMed 15691354Buser D, Weber HP, Lang NP. Tissue integration of non-submerged implants. 1-year results of a prospective study with 100 ITI hollow-cylinder and hollow-screw implants. Clin Oral Implants Res. 1990 Dec;1(1):33-40. doi: 10.1034/j.1600-0501.1990.010105.x.
PubMed 2099210Buser D, Chappuis V, Kuchler U, Bornstein MM, Wittneben JG, Buser R, Cavusoglu Y, Belser UC. Long-term stability of early implant placement with contour augmentation. J Dent Res. 2013 Dec;92(12 Suppl):176S-82S. doi: 10.1177/0022034513504949. Epub 2013 Oct 24.
PubMed 24158332Buser D, Chappuis V, Bornstein MM, Wittneben JG, Frei M, Belser UC. Long-term stability of contour augmentation with early implant placement following single tooth extraction in the esthetic zone: a prospective, cross-sectional study in 41 patients with a 5- to 9-year follow-up. J Periodontol. 2013 Nov;84(11):1517-27. doi: 10.1902/jop.2013.120635. Epub 2013 Jan 24.
PubMed 23347346Chappuis V, Rahman L, Buser R, Janner SFM, Belser UC, Buser D. Effectiveness of Contour Augmentation with Guided Bone Regeneration: 10-Year Results. J Dent Res. 2018 Mar;97(3):266-274. doi: 10.1177/0022034517737755. Epub 2017 Oct 26.
PubMed 29073362Cosyn J, Eghbali A, De Bruyn H, Collys K, Cleymaet R, De Rouck T. Immediate single-tooth implants in the anterior maxilla: 3-year results of a case series on hard and soft tissue response and aesthetics. J Clin Periodontol. 2011 Aug;38(8):746-53. doi: 10.1111/j.1600-051X.2011.01748.x.
PubMed 21752044Cosyn J, Eghbali A, De Bruyn H, Dierens M, De Rouck T. Single implant treatment in healing versus healed sites of the anterior maxilla: an aesthetic evaluation. Clin Implant Dent Relat Res. 2012 Aug;14(4):517-26. doi: 10.1111/j.1708-8208.2010.00300.x. Epub 2010 Jul 17.
PubMed 20662859De Bruyckere T, Eghbali A, Younes F, De Bruyn H, Cosyn J. Horizontal stability of connective tissue grafts at the buccal aspect of single implants: a 1-year prospective case series. J Clin Periodontol. 2015 Sep;42(9):876-882. doi: 10.1111/jcpe.12448. Epub 2015 Sep 16.
PubMed 26373422De Bruyckere T, Eeckhout C, Eghbali A, Younes F, Vandekerckhove P, Cleymaet R, Cosyn J. A randomized controlled study comparing guided bone regeneration with connective tissue graft to re-establish convexity at the buccal aspect of single implants: A one-year CBCT analysis. J Clin Periodontol. 2018 Nov;45(11):1375-1387. doi: 10.1111/jcpe.13006.
PubMed 30133718De Bruyckere T, Cabeza RG, Eghbali A, Younes F, Cleymaet R, Cosyn J. A randomized controlled study comparing guided bone regeneration with connective tissue graft to reestablish buccal convexity at implant sites: A 1-year volumetric analysis. Clin Implant Dent Relat Res. 2020 Aug;22(4):468-476. doi: 10.1111/cid.12934. Epub 2020 Jul 19.
PubMed 32686234De Rouck T, Collys K, Cosyn J. Single-tooth replacement in the anterior maxilla by means of immediate implantation and provisionalization: a review. Int J Oral Maxillofac Implants. 2008 Sep-Oct;23(5):897-904.
PubMed 19014160Eghbali A, De Bruyn H, Cosyn J, Kerckaert I, Van Hoof T. Ultrasonic Assessment of Mucosal Thickness around Implants: Validity, Reproducibility, and Stability of Connective Tissue Grafts at the Buccal Aspect. Clin Implant Dent Relat Res. 2016 Feb;18(1):51-61. doi: 10.1111/cid.12245. Epub 2014 Jul 17.
PubMed 25040828Eghbali A, Seyssens L, De Bruyckere T, Younes F, Cleymaet R, Cosyn J. A 5-year prospective study on the clinical and aesthetic outcomes of alveolar ridge preservation and connective tissue graft at the buccal aspect of single implants. J Clin Periodontol. 2018 Dec;45(12):1475-1484. doi: 10.1111/jcpe.13018. Epub 2018 Nov 5.
PubMed 30290007Furhauser 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 16307569
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Guided Bone Regeneration With Connective Tissue Graft to Re-establish Buccal Convexity at Implant Sites: Three-year Results.
- ClinicalTrials.gov ID
- NCT05143242
- Acronym / sponsor ID
- 23-186
- Conditions
- Guided Bone Regeneration
- Keywords
- connective tissue graft, dental implant, guided bone regeneration, single tooth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- Mar 2020 (actual)
- Study completion
- Apr 2021 (actual)
- First posted
- 3 Dec 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.
The most frequent aesthetic complication following single implant treatment seems to be a lack of buccal convexity. This 'alveolar process deficiency' is the result of buccal bone remodeling following tooth extraction.
A traditional approach to treat alveolar process deficiency is guided bone regeneration (GBR), however post-operative complications such as swelling, bleeding and pain are common and the aesthetic outcome may not be optimal.
An alternative to the traditional GBR approach could be soft tissue contour augmentation using a connective tissue graft (CTG) at the buccal aspect. Possible advantages over GBR include less morbidity at the implant site, a superior aesthetic outcome since there is no need for vertical releasing incisions and less costs since there are no biomaterials to be used.
The primary study objective is to compare the GBR and CTG group in terms of 2 and 3 dimensional tissue alterations, focusing on the amount of tissue gain and volume stability over time. The secondary study objectives are morbidity, overall radiographic, clinical and aesthetic outcomes.
Detailed description
Aim:
This study aims to compare guided bone regeneration (GBR) with connective tissue graft (CTG) to re-establish buccal convexity at single implants.
Sample size calculation:
The sample size calculation was based on the primary study outcome (BSP) and was performed in SAS Power using the Satterthwaite t-test (De Bruyckere et al., 2018). The calculation was based on finding a mean difference of at least 0.5 mm between these groups with a standard deviation of 0.5 mm. This standard deviation was arbitrarily chosen given the lack of comparative studies. Alpha was set at 0.05 and the power was set at 0.80. This resulted in the inclusion of at least 17 patients per group. To compensate for possible drop-outs, 21 patients were included in each group.
Randomization and allocation concealment:
Patients were randomly assigned to the control group (GBR) or test group (CTG). Simple randomization was performed using sealed envelopes with an equal number of envelopes for every treatment group. Group allocation was revealed just prior to surgery by the surgeon and remained concealed for the evaluating investigator during the analytical stage of the project.
Surgical procedure:
In brief, a mucoperiosteal flap was raised in the control group by means of a midcrestal incision, sulcular incisions at both neighbouring teeth and a vertical parapapillary releasing incision at the distal neighbouring tooth. Following implant installation (NobelActive®, Nobel Biocare, Gothenburg, Sweden), the buccal concavity was augmented with deproteinized bovine bone mineral (DBBM) (Bio-Oss®; 0.25 - 1mm; Geistlich Biomaterials, Wolhusen, Switserland) and a collagen membrane (Creos® xenoprotect; 15x20mm; Nobel Biocare, Gothenburg, Sweden). Following apical release of the tissues, a cover screw was installed and primary wound closure was achieved (Seralon® 5/0, Serag Weissner, Naila, Germany). Aftercare included the use of a chlorhexidine rinse, systemic antibiotics (amoxicillin 1g, two times a day) and anti-inflammatory medication (ibuprofen 600mg) as deemed necessary by the patient. After 3 months, the implant was uncovered by means of a pouch procedure. A screw-retained provisional crown was placed as described by De Rouck et al. (2008), which was replaced by the permanent restoration (Procera® on ASC® abutment, Nobel Biocare, Gothenburg, Sweden) 3 months later.
The flap design in the test group was identical to the one in the control group, yet without a vertical parapapillary releasing incision. Instead of augmenting with DBBM, an appropriately sized CTG harvested from the palatal flap or palatal mucosa in the premolar area was pulled into the envelope and immobilized (Seralon® 5/0, Serag Weissner, Naila, Germany). Non-submerged healing was respected. Aftercare and prosthetic procedures were identical in both groups. All surgical treatments and provisional restorations were performed by the same clinician. Referring dentists made permanent restorations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Guided bone regeneration: Control | Active comparator | Procedure: Hard tissue augmentation at the buccal aspect of single implants.Deproteinized bovine derived xenograft (Geistlich Bio-Oss® 0.25 - 1 mm, Geistlich Pharma AG, Wolhusen, Switzerland) |
| Connective tissue graft: Test | Active comparator | Procedure: Soft tissue augmentation at the buccal aspect of single implants.Connective tissue graft harvested from the palate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- At least 18 years old.
- Good oral hygiene defined as full-mouth plaque score ≤ 25% (O'Leary et al.1972
- Presence of a single tooth gap in the anterior maxilla (15 - 25) with both neighbouring teeth present
- Failing tooth at least 3 months earlier removed
- Class I defect at the single tooth gap as clinically assessed (buccopalatal loss of tissue with a normal apicocoronal ridge height) (Seibert, 1983)
Key exclusion criteria (5 listed)
- Systemic diseases
- Smoking
- (History of) periodontal disease
- Untreated caries lesions
- Need for horizontal bone augmentation at the time of implant placement
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 |
|---|---|---|
| Hard tissue augmentation at the buccal aspect of single implants.One or two releasing incisions are made. The periosteum is released and multiple bone perforations are made in the buccal bone prior to the application of deproteinized bovine derived xenograft. A Creos® membrane (Nobel Biocare, Gothenburg, Sweden) is used to cover the occlusal part of the alveolar crest and the xenograft particles. Finally, multiple single monofilament sutures are used for primary tension-free wound closure. | Procedure or surgery | Guided bone regeneration: Control |
| Soft tissue augmentation at the buccal aspect of single implants.A CTG is taken from the palate and transplanted to the buccal side between the alveolar bone and the buccal flap. The CTG is secured with single monofilament sutures. | Procedure or surgery | Connective tissue graft: Test |
Primary outcome
Buccal soft tissue profile
Time frame: Year 1 and 3
The volumetric analysis software (Swissmeda/SMOP, Zürich, Switzerland) calculated a mean dimensional change (mm3) within the AOI (area of interest) for each patient at T5 (3 years). Given the variable size in AOI (mm2) among patients, the mean dimensional change per area was transformed to a mean linear change in buccal soft tissue profile (BSP) in mm.
9 secondary outcomes
Midfacial recession
Time frame: Month 6; Year 1 and 3
Buccal bone thickness
Time frame: Year 1 and 3
Buccal soft tissue thickness
Time frame: Year 1 and 3
Pink Esthetic Score
Time frame: Year 1 and 3
Mucosal Scarring Index
Time frame: Year 1 and 3
Marginal bone loss
Time frame: Year 1 and 3
Probing depth
Time frame: Year 1 and 3
Plaque
Time frame: Year 1 and 3
Bleeding on probing
Time frame: Year 1 and 3
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 3 Dec 2021.
- Background: PubMed 24720375Akcali A, Schneider D, Unlu F, Bicakci N, Kose T, Hammerle CH. Soft tissue augmentation of ridge defects in the maxillary anterior area using two different methods: a randomized controlled clinical trial. Clin Oral Implants Res. 2015 Jun;26(6):688-95. doi: 10.1111/clr.12368. Epub 2014 Apr 10.
- Background: PubMed 15691354Araujo MG, Lindhe J. Dimensional ridge alterations following tooth extraction. An experimental study in the dog. J Clin Periodontol. 2005 Feb;32(2):212-8. doi: 10.1111/j.1600-051X.2005.00642.x.
- Background: PubMed 2099210Buser D, Weber HP, Lang NP. Tissue integration of non-submerged implants. 1-year results of a prospective study with 100 ITI hollow-cylinder and hollow-screw implants. Clin Oral Implants Res. 1990 Dec;1(1):33-40. doi: 10.1034/j.1600-0501.1990.010105.x.
- Background: PubMed 24158332Buser D, Chappuis V, Kuchler U, Bornstein MM, Wittneben JG, Buser R, Cavusoglu Y, Belser UC. Long-term stability of early implant placement with contour augmentation. J Dent Res. 2013 Dec;92(12 Suppl):176S-82S. doi: 10.1177/0022034513504949. Epub 2013 Oct 24.
- Background: PubMed 23347346Buser D, Chappuis V, Bornstein MM, Wittneben JG, Frei M, Belser UC. Long-term stability of contour augmentation with early implant placement following single tooth extraction in the esthetic zone: a prospective, cross-sectional study in 41 patients with a 5- to 9-year follow-up. J Periodontol. 2013 Nov;84(11):1517-27. doi: 10.1902/jop.2013.120635. Epub 2013 Jan 24.
- Background: PubMed 29073362Chappuis V, Rahman L, Buser R, Janner SFM, Belser UC, Buser D. Effectiveness of Contour Augmentation with Guided Bone Regeneration: 10-Year Results. J Dent Res. 2018 Mar;97(3):266-274. doi: 10.1177/0022034517737755. Epub 2017 Oct 26.
- Background: PubMed 21752044Cosyn J, Eghbali A, De Bruyn H, Collys K, Cleymaet R, De Rouck T. Immediate single-tooth implants in the anterior maxilla: 3-year results of a case series on hard and soft tissue response and aesthetics. J Clin Periodontol. 2011 Aug;38(8):746-53. doi: 10.1111/j.1600-051X.2011.01748.x.
- Background: PubMed 20662859Cosyn J, Eghbali A, De Bruyn H, Dierens M, De Rouck T. Single implant treatment in healing versus healed sites of the anterior maxilla: an aesthetic evaluation. Clin Implant Dent Relat Res. 2012 Aug;14(4):517-26. doi: 10.1111/j.1708-8208.2010.00300.x. Epub 2010 Jul 17.
- Background: PubMed 26373422De Bruyckere T, Eghbali A, Younes F, De Bruyn H, Cosyn J. Horizontal stability of connective tissue grafts at the buccal aspect of single implants: a 1-year prospective case series. J Clin Periodontol. 2015 Sep;42(9):876-882. doi: 10.1111/jcpe.12448. Epub 2015 Sep 16.
- Background: PubMed 30133718De Bruyckere T, Eeckhout C, Eghbali A, Younes F, Vandekerckhove P, Cleymaet R, Cosyn J. A randomized controlled study comparing guided bone regeneration with connective tissue graft to re-establish convexity at the buccal aspect of single implants: A one-year CBCT analysis. J Clin Periodontol. 2018 Nov;45(11):1375-1387. doi: 10.1111/jcpe.13006.
- Background: PubMed 32686234De Bruyckere T, Cabeza RG, Eghbali A, Younes F, Cleymaet R, Cosyn J. A randomized controlled study comparing guided bone regeneration with connective tissue graft to reestablish buccal convexity at implant sites: A 1-year volumetric analysis. Clin Implant Dent Relat Res. 2020 Aug;22(4):468-476. doi: 10.1111/cid.12934. Epub 2020 Jul 19.
- Background: PubMed 19014160De Rouck T, Collys K, Cosyn J. Single-tooth replacement in the anterior maxilla by means of immediate implantation and provisionalization: a review. Int J Oral Maxillofac Implants. 2008 Sep-Oct;23(5):897-904.
- Individual participant dataSharing planned: No
Related trials for Guided Bone Regeneration
Active, not recruiting
L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
Not yet recruiting
Clinical Efficacy Assessment of Digitally Fabricated PEEK Barrier Membranes for Guided Bone Regeneration in Severe Bone Defects
Guided Bone Regeneration
Not yet recruitingObservational study
Impact of Gingival Phenotype on Guided Bone Regeneration in the Maxillary Anterior Region
Guided Bone Regeneration
Active, not recruitingObservational study
Evaluation of Bone Regeneration Outcomes Following Guided Bone Regeneration in the Anterior Maxillary Region
Implant Placement in Maxillary Esthetic Zone
Active, not recruitingObservational study
Long-Term Stability of Soft and Hard Tissues After Guided Bone Regeneration in the Maxillary Anterior Region
Alveolar Bone Deficiency
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Hard tissue augmentation at the buccal aspect of single implants. and Soft tissue augmentation at the buccal aspect of single implants. in people with Guided Bone Regeneration, run by University Ghent.
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 7 inclusion and 5 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 3 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Buccal soft tissue profile (time frame: Year 1 and 3). 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 NCT05143242, which also lists 28 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 Dec 2021.