Thin GingivaNCT05211115
Autogenous vs. Xenogeneic Peri-implant Soft Tissue Grafts Placed in Full vs. Split Thickness Flaps
A study testing Split thickness flap, Full thickness flap and Autogenous sub epithelial connective tissue graft in people with Thin Gingiva, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial summary
Randomized, outcome assessor and data analyst blinded, single center trial with four parallel arms and a 1:1:1:1 allocation ratio, with the aim of comparing which combination of bilaminar technique (split vs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thin Gingiva
- What is being tested?
- Split thickness flap, Full thickness flap and Autogenous sub epithelial connective tissue graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 24 Jan 2022to 1 Dec 2024
- 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
- Any male or female adult (≥ 18 year old) patient from the University Complutense of Madrid, being able to sign an informed consent form, presenting a submerged dental implant scheduled to undergo a second stage surgery, which is bounded mesially or distally by a remaining natural tooth, and exhibits a lack of buccal soft tissue volume, will be potentially eligible for this trial.
- The case definition for a lack of buccal soft tissue volume will be the presence of a thin buccal mucosa (< 2mm) or a minor volumetric contraction of the alveolar process (flat or concave buccal mucosal profile at the edentulous area).
Who cannot join
- Patients fitting to all the above inclusion criteria will be not included in the study if unable to attend to the study-related procedures (including the follow-up visits) or if one or more of the following systemic or local exclusion criteria will be found during enrolment or through the study:
- Systemic primary exclusion criteria:
- Compromised general health status contraindicating the study procedures (≥ASA IV);
- Drug abuse, alcohol abuse, or smoking > 10 cigarettes a day;
- Chronic use of corticosteroids, NSAIDs, or immune-modulators (any type, any dose);
- Assumption of bisphosphonates (any type, any dose, past or present);
Show all 16Show fewer
- Pregnant or nursing women;
- Hypersensitivity to paracetamol;
- Local primary exclusion criteria
- History of previous mucogingival surgeries in the area of interest;
- Lack of adequate vestibule depth to perform a bilaminar procedure;
- Lack of osseointegration at the time of implant reopening;
- Need for additional bone grafting at the time of implant reopening;
- Intraoperative evidence of a flap thickness < 0,5mm or > 2mm.
- Secondary exclusion criteria:
- Non compliant patients: poor oral hygiene at 2 consecutive visits.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Department of Periodontology, University Complutense Madrid, Spain
Madrid, 28040
About this study
Official title: Randomised Clinical Trial Comparing Autogenous vs. Xenogeneic Peri-implant Soft Tissue Grafts Placed in Full vs. Split Thickness Flaps: a Clinical, Histological and Vascular Analysis
Randomized, outcome assessor and data analyst blinded, single center trial with four parallel arms and a 1:1:1:1 allocation ratio, with the aim of comparing which combination of bilaminar technique (split vs. full thickness flap) and graft type (autogenous or xenogeneic) provides better clinical, aesthetic, morphological, vascular and patients related outcomes, when augmenting the buccal peri-implant mucosa at the reopening of submerged implant fixtures
Read the detailed description
This randomized four parallel arms controlled clinical trial with blinded outcome assessment and data analysis aims to establish which combination of bilaminar technique (split vs. full thickness flap) and graft type (autogenous subepithelial connective tissue graft vs. volume stable collagen matrix) provides better clinical, aesthetic, morphological, vascular and patients related outcomes, when augmenting the buccal peri-implant mucosa at the reopening of submerged implant fixtures. The primary outcome is the gain in soft tissue thickness (standardised measurement at baseline, after surgery, at 1m and 6m). Secondary outcomes include changes in tissue volume (intraoral scans at baseline, post-op, 14d, 1m, 6m), RAL and KTW (clinical measurements at baseline, 1m, 6m), tissue color integration (∆E at 1m and 6m), and PROMS (7d, 14d, 30d). Exploratory outcomes include tissue morphology (histology at 1m,2m,4m,6m), microcirculation (Doppler flowmetry at pre-op, 7d, 14d, 1m) and revascularization (IHC at 1m,2m,4m,6m). A figure of 10 subjects per group was obtained for a 0,3mm difference in tissue thickness increase (SD 0,23mm), using 80% power, alpha 0.05, and a 10% drop-out rate. Patients will be randomly allocated to four groups: test (STF+VCM), control 1 (FTF+VCM), control 2 (SFT+CTG), control 3 (FTF+CTG). Patients will be the unit of analysis and ANOVA (normality) or Kruskall-Wallis (no normality) tests will be performed setting the significance level at p < 0.05.
- Conditions
- Thin Gingiva
- Being tested
- Split thickness flap, Full thickness flap, Autogenous sub epithelial connective tissue graft, Volume stable collagen matrix
- Keywords
- Soft tissue management, Dental implant, Collagen matrix, Connective tissue graft, Split thickness flap, Full thickness flap
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Split thickness flapProcedure or surgery
Palatally displaced crestal incision at the edentulous site, combined with the split thickness elevation of a buccal flap, extended to the sulcus of the adjacent mesial and distal tooth. Flap elevation performed with a micro-blade, in a buccal and apical direction, for approximately 15mm apical to the crestal incision.
Full thickness flapProcedure or surgery
Palatally displaced crestal incision at the edentulous site, combined with the full thickness elevation of a buccal flap, extended to the sulcus of the adjacent mesial and distal tooth. Flap elevation performed with a fine periosteal elevator, in a buccal and apical direction, for approximately 15mm apical to the crestal incision.
Autogenous sub epithelial connective tissue graftProcedure or surgery
Harvest of a sub epithelial connective tissue graft using a double incision technique, approximately 2-3 mm apical to the palatal gingival margins of the first and second premolars. Graft dimension standardised as 10mm (mesio-distally) by 6-8mm (apico-coronally) by 1,5mm (thickness). Graft stabilised at the inner aspect of the buccal flap, 1mm apical to the flap margin, using one mesial and one distal horizontal mattress sutures.
Volume stable collagen matrixProcedure or surgery
Geistlich Fibro-Gide® matrix shaped at a standardised dimension of 10mm (mesio-distally) by 6-8mm (apico-coronally) by 6mm (thickness). Matrix stabilised at the inner aspect of the buccal flap, 1mm apical to the flap margin, using one mesial and one distal horizontal mattress sutures.
| Study group | Role | What they receive |
|---|---|---|
| Split thickness flap + Volume stable collagen matrix | Experimental | A split thickness flap will be raised with a micro-blade, keeping a flap thickness >0,5mm. The healing abutment will be connected to the implant, and a 10mm wide, 6-8mm high, 6mm thick volume stable collagen matrix will be stabilised at the inner aspect of the flap. Receives: Procedure: Split thickness flap; Procedure: Volume stable collagen matrix |
| Full thickness flap + Volume stable collagen matrix | Active comparator | A full thickness flap will be raised with a periosteal elevator. The healing abutment will be connected to the implant, and a 10mm wide by 6-8mm high volume stable collagen matrix will be stabilised at the inner aspect of the flap. Receives: Procedure: Full thickness flap; Procedure: Volume stable collagen matrix |
| Split thickness flap + Autogenous connective tissue | Active comparator | A split thickness flap will be raised with a micro-blade, keeping a flap thickness >0,5mm. The healing abutment will be connected to the implant, and a 10mm wide, 6-8mm high, 1,5mm thick autogenous sub epithelial connective tissue graft will be stabilised at the inner aspect of the flap. Receives: Procedure: Split thickness flap; Procedure: Autogenous sub epithelial connective tissue graft |
| Full thickness flap + Autogenous connective tissue | Active comparator | A full thickness flap will be raised with a periosteal elevator. The healing abutment will be connected to the implant, and a 10mm wide, 6-8mm high, 1,5mm thick autogenous sub epithelial connective tissue graft will be stabilised at the inner aspect of the flap. Receives: Procedure: Full thickness flap; Procedure: Autogenous sub epithelial connective tissue graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Buccal soft tissue thickness
Changes in the thickness of the buccal peri-implant mucosa, measured with trans-gingival probing.
Measured: before surgery, after surgery, 1 month after surgery, 6 months after surgery
Secondary outcomes (12)
Volume changes
Changes in the size of the buccal peri-implant tissues and in their volume distribution, measured with a digital volumetric analysis.
Measured: before surgery, after surgery, 14 days after surgery, 1 month after surgery, 6 months after surgery
Attachment level
Relative attachment level (implant) and clinical attachment level (adjacent tooth) measured with a standardised UNC-15 probe.
Measured: baseline, after surgery, 1 month after surgery, 6 months after surgery
Colorimetric integration
Colorimetric integration of the augmented buccal peri-implant mucosa, relative to the buccal attached gingiva of the mesial and distal adjacent tooth, quantified throughout the ∆E score, calculated on standardised digital photographs.
Measured: 1 month after surgery, 6 months after surgery
Patients related outcome measures
Patients pain and discomfort with respect to the procedure evaluated with the short form of the McGill pain questionnaire (SF-MPQ).
Measured: 7 days after surgery, 14 days after surgery, 1 month after surgery, 6 months after surgery
Microcirculation of the grafted area
Microcirculation of the treated area evaluated with a laser Doppler flowmeter.
Measured: before surgery, after surgery, 7 days after surgery, 14 days after surgery, 1 month after surgery, 6 months after surgery
Morphology of the grafted area
Descriptive histology performed on paraffin embedded sections from buccal gingival specimens, stained with hematoxylin-eosin.
Measured: 1 month after surgery or 2 months after surgery or 4 months after surgery or 6 months after surgery
Revascularization and reinnervation of the grafted area
Immune histochemistry performed on paraffin embedded, hematoxylin-eosin stained sections using markers of tissue revascularization and reinnervation.
Measured: 1 month after surgery or 2 months after surgery or 4 months after surgery or 6 months after surgery
Full mouth Plaque score
Full muouth plaque score measured with a standardised UNC-15 probe.
Measured: baseline, after surgery, 1 month after surgery, 6 months after surgery
Full mouth Bleeding score
Full mouth bleeding score measured with a standardised UNC-15 probe.
Measured: baseline, after surgery, 1 month after surgery, 6 months after surgery
Keratinised tissue width
Keratinised tissue width measured with a standardised UNC-15 probe.
Measured: baseline, after surgery, 1 month after surgery, 6 months after surgery
Bleeding on probing
Presence/absence of bleeding on probing at the treated implant measured with a standardised UNC-15 probe.
Measured: baseline, after surgery, 1 month after surgery, 6 months after surgery
Modified Plaque index
Presence/absence of plaque at the treated implant
Measured: baseline, after surgery, 1 month after surgery, 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start24 Jan 2022
- Primary completion15 Dec 2023
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Thin GingivaStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Osteology Foundation
- Responsible party
- Sponsor
- Investigators
- Mariano Sanz Alonso, Study chair, Faculty of Odontology, University Complutense, Madrid, SpainDavid Palombo, Study director, Faculty of Odontology, University Complutense, Madrid, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05211115
- Sponsor's protocol ID
- 19-102
- Status last verified
- May 2023
- First submitted
- 12 Jan 2022
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD
Publications
Chappuis V, Araujo MG, Buser D. Clinical relevance of dimensional bone and soft tissue alterations post-extraction in esthetic sites. Periodontol 2000. 2017 Feb;73(1):73-83. doi: 10.1111/prd.12167.
PubMed 28000281Johnston WM, Kao EC. Assessment of appearance match by visual observation and clinical colorimetry. J Dent Res. 1989 May;68(5):819-22. doi: 10.1177/00220345890680051301.
PubMed 2715476McLean TN, Smith BA, Morrison EC, Nasjleti CE, Caffesse RG. Vascular changes following mucoperiosteal flap surgery: a fluorescein angiography study in dogs. J Periodontol. 1995 Mar;66(3):205-10. doi: 10.1902/jop.1995.66.3.205.
PubMed 7776165Melzack R. The short-form McGill Pain Questionnaire. Pain. 1987 Aug;30(2):191-197. doi: 10.1016/0304-3959(87)91074-8.
PubMed 3670870Perotto S, Romano F, Cricenti L, Gotti S, Aimetti M. Vascularization and Innervation of Connective Tissue Grafts in the Treatment of Gingival Recessions: A Histologic and Immunohistochemical Study. Int J Periodontics Restorative Dent. 2017 Jul/Aug;37(4):551-558. doi: 10.11607/prd.3020.
PubMed 28609502Rojo E, Stroppa G, Sanz-Martin I, Gonzalez-Martin O, Alemany AS, Nart J. Soft tissue volume gain around dental implants using autogenous subepithelial connective tissue grafts harvested from the lateral palate or tuberosity area. A randomized controlled clinical study. J Clin Periodontol. 2018 Apr;45(4):495-503. doi: 10.1111/jcpe.12869. Epub 2018 Feb 23.
PubMed 29334403Sanz-Martin I, Encalada C, Sanz-Sanchez I, Aracil J, Sanz M. Soft tissue augmentation at immediate implants using a novel xenogeneic collagen matrix in conjunction with immediate provisional restorations: A prospective case series. Clin Implant Dent Relat Res. 2019 Feb;21(1):145-153. doi: 10.1111/cid.12696. Epub 2018 Dec 3.
PubMed 30508313Tatarakis N, Gkranias N, Darbar U, Donos N. Blood flow changes using a 3D xenogeneic collagen matrix or a subepithelial connective tissue graft for root coverage procedures: a pilot study. Clin Oral Investig. 2018 May;22(4):1697-1705. doi: 10.1007/s00784-017-2261-5. Epub 2017 Oct 27.
PubMed 29080078Thoma DS, Zeltner M, Hilbe M, Hammerle CH, Husler J, Jung RE. Randomized controlled clinical study evaluating effectiveness and safety of a volume-stable collagen matrix compared to autogenous connective tissue grafts for soft tissue augmentation at implant sites. J Clin Periodontol. 2016 Oct;43(10):874-85. doi: 10.1111/jcpe.12588. Epub 2016 Aug 12.
PubMed 27310522Thoma DS, Naenni N, Figuero E, Hammerle CHF, Schwarz F, Jung RE, Sanz-Sanchez I. Effects of soft tissue augmentation procedures on peri-implant health or disease: A systematic review and meta-analysis. Clin Oral Implants Res. 2018 Mar;29 Suppl 15:32-49. doi: 10.1111/clr.13114.
PubMed 29498129
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Clinical Trial Comparing Autogenous vs. Xenogeneic Peri-implant Soft Tissue Grafts Placed in Full vs. Split Thickness Flaps: a Clinical, Histological and Vascular Analysis
- ClinicalTrials.gov ID
- NCT05211115
- Acronym / sponsor ID
- 19-102
- Conditions
- Thin Gingiva
- Keywords
- Soft tissue management, Dental implant, Collagen matrix, Connective tissue graft, Split thickness flap, Full thickness flap
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Collaborators
- Osteology Foundation
- Study start
- 24 Jan 2022 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 27 Jan 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.
Randomized, outcome assessor and data analyst blinded, single center trial with four parallel arms and a 1:1:1:1 allocation ratio, with the aim of comparing which combination of bilaminar technique (split vs. full thickness flap) and graft type (autogenous or xenogeneic) provides better clinical, aesthetic, morphological, vascular and patients related outcomes, when augmenting the buccal peri-implant mucosa at the reopening of submerged implant fixtures
Detailed description
This randomized four parallel arms controlled clinical trial with blinded outcome assessment and data analysis aims to establish which combination of bilaminar technique (split vs. full thickness flap) and graft type (autogenous subepithelial connective tissue graft vs. volume stable collagen matrix) provides better clinical, aesthetic, morphological, vascular and patients related outcomes, when augmenting the buccal peri-implant mucosa at the reopening of submerged implant fixtures. The primary outcome is the gain in soft tissue thickness (standardised measurement at baseline, after surgery, at 1m and 6m). Secondary outcomes include changes in tissue volume (intraoral scans at baseline, post-op, 14d, 1m, 6m), RAL and KTW (clinical measurements at baseline, 1m, 6m), tissue color integration (∆E at 1m and 6m), and PROMS (7d, 14d, 30d). Exploratory outcomes include tissue morphology (histology at 1m,2m,4m,6m), microcirculation (Doppler flowmetry at pre-op, 7d, 14d, 1m) and revascularization (IHC at 1m,2m,4m,6m). A figure of 10 subjects per group was obtained for a 0,3mm difference in tissue thickness increase (SD 0,23mm), using 80% power, alpha 0.05, and a 10% drop-out rate. Patients will be randomly allocated to four groups: test (STF+VCM), control 1 (FTF+VCM), control 2 (SFT+CTG), control 3 (FTF+CTG). Patients will be the unit of analysis and ANOVA (normality) or Kruskall-Wallis (no normality) tests will be performed setting the significance level at p < 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Split thickness flap + Volume stable collagen matrix | Experimental | Procedure: Split thickness flap, Procedure: Volume stable collagen matrixA split thickness flap will be raised with a micro-blade, keeping a flap thickness >0,5mm. The healing abutment will be connected to the implant, and a 10mm wide, 6-8mm high, 6mm thick volume stable collagen matrix will be stabilised at the inner aspect of the flap. |
| Full thickness flap + Volume stable collagen matrix | Active comparator | Procedure: Full thickness flap, Procedure: Volume stable collagen matrixA full thickness flap will be raised with a periosteal elevator. The healing abutment will be connected to the implant, and a 10mm wide by 6-8mm high volume stable collagen matrix will be stabilised at the inner aspect of the flap. |
| Split thickness flap + Autogenous connective tissue | Active comparator | Procedure: Split thickness flap, Procedure: Autogenous sub epithelial connective tissue graftA split thickness flap will be raised with a micro-blade, keeping a flap thickness >0,5mm. The healing abutment will be connected to the implant, and a 10mm wide, 6-8mm high, 1,5mm thick autogenous sub epithelial connective tissue graft will be stabilised at the inner aspect of the flap. |
| Full thickness flap + Autogenous connective tissue | Active comparator | Procedure: Full thickness flap, Procedure: Autogenous sub epithelial connective tissue graftA full thickness flap will be raised with a periosteal elevator. The healing abutment will be connected to the implant, and a 10mm wide, 6-8mm high, 1,5mm thick autogenous sub epithelial connective tissue graft will be stabilised at the inner aspect of the flap. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Any male or female adult (≥ 18 year old) patient from the University Complutense of Madrid, being able to sign an informed consent form, presenting a submerged dental implant scheduled to undergo a second stage surgery, which is bounded mesially or distally by a remaining natural tooth, and exhibits a lack of buccal soft tissue volume, will be potentially eligible for this trial.
- The case definition for a lack of buccal soft tissue volume will be the presence of a thin buccal mucosa (< 2mm) or a minor volumetric contraction of the alveolar process (flat or concave buccal mucosal profile at the edentulous area).
Key exclusion criteria (16 listed)
- Patients fitting to all the above inclusion criteria will be not included in the study if unable to attend to the study-related procedures (including the follow-up visits) or if one or more of the following systemic or local exclusion criteria will be found during enrolment or through the study:
- Compromised general health status contraindicating the study procedures (≥ASA IV);
- Drug abuse, alcohol abuse, or smoking > 10 cigarettes a day;
- Chronic use of corticosteroids, NSAIDs, or immune-modulators (any type, any dose);
- Assumption of bisphosphonates (any type, any dose, past or present);
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 |
|---|---|---|
| Split thickness flapPalatally displaced crestal incision at the edentulous site, combined with the split thickness elevation of a buccal flap, extended to the sulcus of the adjacent mesial and distal tooth. Flap elevation performed with a micro-blade, in a buccal and apical direction, for approximately 15mm apical to the crestal incision. | Procedure or surgery | Split thickness flap + Autogenous connective tissue, Split thickness flap + Volume stable collagen matrix |
| Full thickness flapPalatally displaced crestal incision at the edentulous site, combined with the full thickness elevation of a buccal flap, extended to the sulcus of the adjacent mesial and distal tooth. Flap elevation performed with a fine periosteal elevator, in a buccal and apical direction, for approximately 15mm apical to the crestal incision. | Procedure or surgery | Full thickness flap + Autogenous connective tissue, Full thickness flap + Volume stable collagen matrix |
| Autogenous sub epithelial connective tissue graftHarvest of a sub epithelial connective tissue graft using a double incision technique, approximately 2-3 mm apical to the palatal gingival margins of the first and second premolars. Graft dimension standardised as 10mm (mesio-distally) by 6-8mm (apico-coronally) by 1,5mm (thickness). Graft stabilised at the inner aspect of the buccal flap, 1mm apical to the flap margin, using one mesial and one distal horizontal mattress sutures. | Procedure or surgery | Full thickness flap + Autogenous connective tissue, Split thickness flap + Autogenous connective tissue |
| Volume stable collagen matrixGeistlich Fibro-Gide® matrix shaped at a standardised dimension of 10mm (mesio-distally) by 6-8mm (apico-coronally) by 6mm (thickness). Matrix stabilised at the inner aspect of the buccal flap, 1mm apical to the flap margin, using one mesial and one distal horizontal mattress sutures. | Procedure or surgery | Full thickness flap + Volume stable collagen matrix, Split thickness flap + Volume stable collagen matrix |
Primary outcome
Buccal soft tissue thickness
Time frame: before surgery, after surgery, 1 month after surgery, 6 months after surgery
Changes in the thickness of the buccal peri-implant mucosa, measured with trans-gingival probing.
12 secondary outcomes
Volume changes
Time frame: before surgery, after surgery, 14 days after surgery, 1 month after surgery, 6 months after surgery
Attachment level
Time frame: baseline, after surgery, 1 month after surgery, 6 months after surgery
Colorimetric integration
Time frame: 1 month after surgery, 6 months after surgery
Patients related outcome measures
Time frame: 7 days after surgery, 14 days after surgery, 1 month after surgery, 6 months after surgery
Microcirculation of the grafted area
Time frame: before surgery, after surgery, 7 days after surgery, 14 days after surgery, 1 month after surgery, 6 months after surgery
Morphology of the grafted area
Time frame: 1 month after surgery or 2 months after surgery or 4 months after surgery or 6 months after surgery
Revascularization and reinnervation of the grafted area
Time frame: 1 month after surgery or 2 months after surgery or 4 months after surgery or 6 months after surgery
Full mouth Plaque score
Time frame: baseline, after surgery, 1 month after surgery, 6 months after surgery
Full mouth Bleeding score
Time frame: baseline, after surgery, 1 month after surgery, 6 months after surgery
Keratinised tissue width
Time frame: baseline, after surgery, 1 month after surgery, 6 months after surgery
Bleeding on probing
Time frame: baseline, after surgery, 1 month after surgery, 6 months after surgery
Modified Plaque index
Time frame: baseline, after surgery, 1 month after surgery, 6 months after surgery
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 19 Dec 2024.
- Results publication: PubMed 28000281Chappuis V, Araujo MG, Buser D. Clinical relevance of dimensional bone and soft tissue alterations post-extraction in esthetic sites. Periodontol 2000. 2017 Feb;73(1):73-83. doi: 10.1111/prd.12167.
- Results publication: PubMed 2715476Johnston WM, Kao EC. Assessment of appearance match by visual observation and clinical colorimetry. J Dent Res. 1989 May;68(5):819-22. doi: 10.1177/00220345890680051301.
- Results publication: PubMed 7776165McLean TN, Smith BA, Morrison EC, Nasjleti CE, Caffesse RG. Vascular changes following mucoperiosteal flap surgery: a fluorescein angiography study in dogs. J Periodontol. 1995 Mar;66(3):205-10. doi: 10.1902/jop.1995.66.3.205.
- Results publication: PubMed 3670870Melzack R. The short-form McGill Pain Questionnaire. Pain. 1987 Aug;30(2):191-197. doi: 10.1016/0304-3959(87)91074-8.
- Results publication: PubMed 28609502Perotto S, Romano F, Cricenti L, Gotti S, Aimetti M. Vascularization and Innervation of Connective Tissue Grafts in the Treatment of Gingival Recessions: A Histologic and Immunohistochemical Study. Int J Periodontics Restorative Dent. 2017 Jul/Aug;37(4):551-558. doi: 10.11607/prd.3020.
- Results publication: PubMed 29334403Rojo E, Stroppa G, Sanz-Martin I, Gonzalez-Martin O, Alemany AS, Nart J. Soft tissue volume gain around dental implants using autogenous subepithelial connective tissue grafts harvested from the lateral palate or tuberosity area. A randomized controlled clinical study. J Clin Periodontol. 2018 Apr;45(4):495-503. doi: 10.1111/jcpe.12869. Epub 2018 Feb 23.
- Results publication: PubMed 30508313Sanz-Martin I, Encalada C, Sanz-Sanchez I, Aracil J, Sanz M. Soft tissue augmentation at immediate implants using a novel xenogeneic collagen matrix in conjunction with immediate provisional restorations: A prospective case series. Clin Implant Dent Relat Res. 2019 Feb;21(1):145-153. doi: 10.1111/cid.12696. Epub 2018 Dec 3.
- Results publication: PubMed 29080078Tatarakis N, Gkranias N, Darbar U, Donos N. Blood flow changes using a 3D xenogeneic collagen matrix or a subepithelial connective tissue graft for root coverage procedures: a pilot study. Clin Oral Investig. 2018 May;22(4):1697-1705. doi: 10.1007/s00784-017-2261-5. Epub 2017 Oct 27.
- Results publication: PubMed 27310522Thoma DS, Zeltner M, Hilbe M, Hammerle CH, Husler J, Jung RE. Randomized controlled clinical study evaluating effectiveness and safety of a volume-stable collagen matrix compared to autogenous connective tissue grafts for soft tissue augmentation at implant sites. J Clin Periodontol. 2016 Oct;43(10):874-85. doi: 10.1111/jcpe.12588. Epub 2016 Aug 12.
- Results publication: PubMed 29498129Thoma DS, Naenni N, Figuero E, Hammerle CHF, Schwarz F, Jung RE, Sanz-Sanchez I. Effects of soft tissue augmentation procedures on peri-implant health or disease: A systematic review and meta-analysis. Clin Oral Implants Res. 2018 Mar;29 Suppl 15:32-49. doi: 10.1111/clr.13114.
- Individual participant dataSharing planned: No. There is no plan to share IPD
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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.
Mariano Sanz Alonso study chair
Faculty of Odontology, University Complutense, Madrid, Spain
David Palombo study director
Faculty of Odontology, University Complutense, Madrid, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Split thickness flap, Full thickness flap and Autogenous sub epithelial connective tissue graft in people with Thin Gingiva, run by Universidad Complutense de Madrid at 1 site in Spain.
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 2 inclusion and 16 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 19 Dec 2024. 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 Spain. 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?
Buccal soft tissue thickness (time frame: before surgery, after surgery, 1 month after surgery, 6 months after surgery). 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 NCT05211115, which also lists 10 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 19 Dec 2024.