Peri-Implantational LossNCT06261268
Strip Graft w/ Xenogeneic Matrix vs Free Gingival Graft for the Augmentation of Peri-implant Keratinized Mucosa
A study testing Strip graft with Mucograft and Free gingival graft in people with Peri-Implantational Loss and Surgical Wound, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial summary
The primary objective of this study is to compare changes in peri-implant keratinized mucosa (PIKM) following the application of apically repositioned flap (ARF) using a combination of a Strip graft and a Xenogeneic matrix, or with a free gingival graft (FGG), in implants in the second stage with <2 mm of PIKM. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Peri-Implantational Loss, Surgical Wound, Healing Surgical Wounds
- What is being tested?
- Strip graft with Mucograft and Free gingival graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSpain
- Study dates
- 29 Jan 2024to 9 Apr 2027
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients older than 18 years
- Short-span dental implants in the mandible at second stage with inadequate PIKM (<2 mm) with at least one adjacent tooth mesially
- Periodontally healthy patients with a pristine or reduced periodontium
- Plaque index (FMPS) less than 20%.
Who cannot join
- Compromised general health status that contraindicates study procedures (≥ASA III);
- Drug or alcohol abuse;
- Smoking of > 10 cigarettes per day;
- Chronic use of corticosteroids, NSAIDs or immunomodulators (any type or dose);
- Pregnant or lactating women;
- History of previous mucogingival surgeries in the area of interest
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Strip Graft With Xenogeneic Matrix Versus Free Gingival Graft for the Augmentation of Peri-implant Keratinized Mucosa: A Randomized Clinical Trial With Vascular Analysis
The primary objective of this study is to compare changes in peri-implant keratinized mucosa (PIKM) following the application of apically repositioned flap (ARF) using a combination of a Strip graft and a Xenogeneic matrix, or with a free gingival graft (FGG), in implants in the second stage with <2 mm of PIKM.
Additionally, as a secondary objective, the investigators compare postoperative blood supply in both recipient and donor sites based on the type of graft obtained. Meanwhile, the investigators evaluate differences between the two groups concerning microcirculation values (perfusion units, PU), soft tissue thickness (STT), volume change, vestibular depth, as well as clinical, aesthetic, and patient-reported outcome measures (PROMS).
Read the detailed description
- BACKGROUND The importance of keratinized tissue around teeth and dental implants is a frequently investigated topic in the literature. The need for an adequate amount of peri-implant keratinized mucosa (PIKM), which is defined as a minimum width of 2 mm is demonstrated according to a recently published systematic review and consensus report. The standard of care in the PIKM augmentation is the apically repositioned flap (ARF) combined with a free gingival graft (FGG), as it represents a predictable and documented strategy to gain KT width. However, such technique implies the harvest of abundant autogenous grafts, and is frequently associated to sub-optimal aesthetic results due to the poor color mimicry of the grafted tissue. In light of such limitations, some alternatives based on the use of soft tissue substitutes have been proposed, with the aim of reducing surgical invasiveness through the avoidance of large autogenous grafts and improving aesthetic outcomes. Among those, the sole use of as xenogeneic collagen matrices (XCM) has been associated with promising clinical outcomes albeit with lesser KT width gains as compared to autogenous FGGs. Recently, a novel approach called the Strip Technique (ST) has been introduced, where the exposed periosteal bed of a ARF is covered with the combination of a xenogeneic collagen matrix and a 2-3 mm wide strip of autogenous free gingival graft, sutured at the apical border of the matrix. The rationale for this "combined grafting technique" stands on reducing surgical invasiveness and improving color mimicry through the use of a XCM, while providing a source of autogenous keratinizing cells in the apical border of the grafted area to promote better PIKM gains. Albeit this new approach seems promising, there is limited evidence regarding its clinical efficacy and there is a lack of knowledge regarding how the adoption of such combined approach affects the re-perfusion of the grafted tissue and the overall microvascular healing of the surgical site. Furthermore, the pattern of the revascularization of both the autologous grafts and the XCM requires further understanding. Most of our recent knowledge comes from classical animal studies that evaluated the microvascularization of FGG when placed over periosteum with microscopy. The postoperative blood supply of these free grafts is of key importance to their survival. Recently a new non-invasive technique has been introduced in the field of medicine and dentistry the Laser Speckle Contrast Imaging (LSCI) system, that provides further understanding on the dynamics of postoperative blood supply of the applied grafts and elucidate regarding the healing pattern of the strip combination technique.
- JUSTIFICATION There is a lack of knowledge regarding the clinical performance, the healing pattern and the dynamics of revascularization when performing apically repositioned flaps combined with either the autogenous strip-XCM technique or autogenous FGGs.
Results from this study could assess whether the strip-XCM technique represents a reliable, less invasive, and simplified alternative to autogenous FGGs for the increase of PIKM.
Moreover, it could provide additional knowledge regarding the healing and revascularization pattern of both strip-XCM and FGGs around dental implants, assessed through an innovative technology as Laser Speckle Perfusion.
- Being tested
- Strip graft with Mucograft, Free gingival graft
- Keywords
- Strip graft, Free gingival graft, Peri-implant keratinized mucosa, Soft tissue augmentation, Early wound healing, Postoperative blood supply
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strip graft with MucograftProcedure or surgery
An apically repositioned flap is made in the vestibular region. The flap is then elevated with a split-thickness preparation, and the mucogingival junction will be repositioned apically and fixed with periosteal-anchored sutures. Then, a free epithelialized gingival strip graft will be harvested from the molar area of the palate. The "Strip" graft is sutured to the apical end of the recipient bed. The remaining uncovered part of the periosteal bed will be covered with a xenogeneic collagen matrix (Mucograft®. Geistlich Pharma AG, Wolhusen, Switzerland) fixed with simple interrupted and crossed sutures. The edges of the palatal wound (donor area) will be approximated with crossed sutures.
Free gingival graftProcedure or surgery
The preparation of the apically repositioned flap and the recipient bed with its apico-coronal design and dimension is performed as in the test group. Subsequently, an epithelialized free gingival graft with the size of the entire recipient area with a thickness of 2 mm will be harvested from the molar area of the palate. The graft is sutured to the recipient periosteal bed using simple interrupted and crossed sutures. In the donor area, a collagen sponge is sutured to the wound by means of crossed sutures.
| Study group | Role | What they receive |
|---|---|---|
| Strip graft with Mucograft | Experimental | An apically repositioned flap is prepared then, a free epithelialized gingival strip graft is harvested from the molar area of the palate and sutured to the apical part of the recipient area. A xenogeneic collagen matrix (Mucograft®. Geistlich Pharma AG, Wolhusen, Switzerland) covers the remaining uncovered part of the periosteal bed. Receives: Procedure: Strip graft with Mucograft |
| Free gingival graft | Active comparator | Apically repositioned flap is prepared. An epithelialized free gingival graft is harvested from the molar area of the palate, and sutured to the recipient area Receives: Procedure: Free gingival graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in peri-implant keratinized mucosa width (mm)
the apico-coronal linear dimension of the buccal peri-implant keratinized mucosa (PIKM) will be measured with a UNC15 periodontal probe (Hu-Friedy manufacturing, Co., LLC, Chicago, USA) as the linear dimension of the buccal vestibule, from the buccal peri-implant mucosa margin to the mucogingival junction at the mid-buccal aspect of the treated implant and adjacent mesial tooth.
Measured: Baseline, 1, 3, 6 and 12 months
Secondary outcomes (15)
Vascularization (in Laser Speckle perfusion units [LSPU])
Vascularization will be measured using Laser Speckle Contrast Imaging (LSCI) (PeriCam PSI System; Perimed AB, Sweden). This novel technology represents a validated, non-invasive, real time, chair side mean to provide contrast based bi-dimensional representations of the superficial vascular network of a given tissue surface.
Measured: pre-surgically, post-surgically at 4, 7, 10, 14 and 30 days, and at 3-6 and 12 months
Changes in soft tissue thickness (STT) (mm)
STT will be measured by ultrasonography with a dental Pirop® ultrasound device (Echoson Company, Poland). The equipment is validated in experimental and clinical studies. Patients will undergo a clinical and ultrasound examination before gingival augmentation, as well as right after the surgery, at 1, 3, 6 and 12 months after, in order to evaluate STT at two different apico-coronal location. It will be measured at the mid-buccal aspect of the implant. Point 1 will be located 2 mm from the periimplant mucosal margin and point 2 will be considered at the mucogingival junction (MGJ).
Measured: Baseline, post-op, 1, 3, 6 and 12 months
Vestibule depth (VD) (mm)
VD will be measured with a UNC15 periodontal probe (Hu-Friedy manufacturing, Co., LLC, Chicago, USA) as the linear dimension of the buccal vestibule. At the mid-buccal aspect of the treated implant from the peri-implant soft tissue margin to the greatest concavity of the vestibule crease, retracting the lips with a spandex retractor for intraoral photography
Measured: Pre-surgically, and at 30 days, 3-6 and 12 months
Probing pocket depth (PPD) (mm)
Probing depth will be measured from the peri-implant mucosal margin to the bottom of the sulcus, at 6 locations per implant, using a UNC15 periodontal probe (Hu-Friedy manufacturing, Co., LLC, Chicago, USA), approximating to the nearest 0.5 mm.
Measured: pre-surgically, at 3, 6 and 12 months after surgery
Dehiscence (mm)
Recession will be measured from the peri-implant mucosal margin to the top of the healing abutment, at 6 locations per implant, using a UNC15 periodontal probe (Hu-Friedy manufacturing, Co., LLC, Chicago, USA), approximating to the nearest 0.5 mm.
Measured: post-surgically, at 3, 6 and 12 months after surgery
Full-mouth plaque score (FMPS)
Full-mouth plaque score (FMPS) will be measured using a calibrated UNC15 periodontal probe (UNC15 periodontal probe (Hu-Friedy manufacturing, Co., LLC, Chicago, USA). Score will be expressed in percentage (%), it will be calculated by the number of sites where plaque is recorded is divided by the total number of available sites in the mouth and multiplied by 100 to express the bleeding index as a percentage. 6 sites per tooth is recorded.
Measured: Baseline, 1 month, 3 months, 6 and 12 months
Volumetric changes
Changes in the peri-implant tissue volume distribution will be analyzed by digital volumetric analysis (DVA), comparing preoperative data with measurements collected at different time points. At each time point, the treated area will be optically scanned with a 3D scanner (Medit i500, Medit Corp., Seoul, South Korea) and standard tessellation language (STL) will be analyzed with a dedicated software (Smop® Swissmeda Software, Swissmeda AG, Zurich, Switzerland), to superimpose the digital models acquired at the different timepoints. For each overlay, a sagittal section perpendicular to the implant axis in its central part (largest diameter) will be selected. A line coincident with the longitudinal axis of the implant will then be drawn on the cross-sectional images of such section, and an image capture (ImageJ, National Institutes of Health, Maryland, USA) will be exported for horizontal measurements.
Measured: Baseline, 14 days, 1 month, 3, 6 and 12 months
Patient reported outcome measures (PROMS)
Patients' pain and discomfort with respect to the procedure will be assessed on a visual analogue scale (VAS) (0-10 cm, where 0 is the worst and 10 is the best). In addition, patients will be asked to report the amount of paracetamol they have consumed for pain control each day during the first postoperative week. Patients will be asked to fill out an additional questionnaire at 6 months and 1 year about their perception of the treatment. Aspects will be as follows: comfort of the treated area (during mastication and brushing) and aesthetic.
Measured: immediately after the surgery, 12 hours after the surgery, 1 day, 2, 3, 4, 5, 6, 7 days and 2 weeks after the surgery
Esthetic analysis
An examiner blinded to the patient allocation will assess the 30-day, 3-, 6- and 12-month photographs to score the aesthetic outcome of the intervention in Visual Analogue Scale (VAS) (0-10cm, where 0 is the worst and 10 is the best). The following aspects will be evaluated: color matching, tissue blending and the satisfaction of the patient.
Measured: 30-day, 3-, 6- and 12-month
Intra-surgical parameters
Both the harvested grafts, the applied xenogeneic matrix' dimension and the prepared recipient site will be measured and documented during the surgery. The measurements will be done using a UNC15 periodontal probe (Hu-Friedy manufacturing, Co., LLC, Chicago, USA), to the nearest 0.5 mm.
Measured: During surgery
Intra-surgical time
Surgical time will be recorded.
Measured: During the surgery
Demographic data
affiliation data (age and sex) is recorded. For age the birthdate is recorded.
Measured: Baseline
Anamnesis data
previous medical history (systemic diseases, medication, allergies)
Measured: Baseline, through study completion, an average of 1 year
Smoking habit
Smoking habit is recorded in number of cigarettes per day.
Measured: Baseline, through study completion, an average of 1 year
Full-mouth bleeding score (FMBS) (%)
Full-mouth bleeding score (FMBS) will be measured using a calibrated UNC15 periodontal probe (UNC15 periodontal probe (Hu-Friedy manufacturing, Co., LLC, Chicago, USA). Score will be expressed in percentage (%), it will be calculated by the number of sites where bleeding is recorded is divided by the total number of available sites in the mouth and multiplied by 100 to express the bleeding index as a percentage. 6 sites per tooth is recorded.
Measured: Baseline, 1 month, 3 months, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start29 Jan 2024
- Primary completion9 Apr 2027 (estimated)
- Study completion9 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Peri-Implantational LossStudies 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
- Model description
- A randomized controlled equivalence clinical trial will be performed, with two parallel groups, a 1:1 allocation ratio, and a 12-month follow-up.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mariano Sanz Alonso, Study director, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06261268
- Sponsor's protocol ID
- Strip vs FGG
- Status last verified
- Apr 2026
- First submitted
- 16 Jan 2024
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ramanauskaite A, Schwarz F, Sader R. Influence of width of keratinized tissue on the prevalence of peri-implant diseases: A systematic review and meta-analysis. Clin Oral Implants Res. 2022 Jun;33 Suppl 23:8-31. doi: 10.1111/clr.13766.
PubMed 35763022Sanz M, Schwarz F, Herrera D, McClain P, Figuero E, Molina A, Monje A, Montero E, Pascual A, Ramanauskaite A, Renouard F, Sader R, Schiegnitz E, Urban I, Heitz-Mayfield L. Importance of keratinized mucosa around dental implants: Consensus report of group 1 of the DGI/SEPA/Osteology Workshop. Clin Oral Implants Res. 2022 Jun;33 Suppl 23:47-55. doi: 10.1111/clr.13956.
PubMed 35763021Montero E, Molina A, Matesanz P, Monje A, Sanz-Sanchez I, Herrera D. Efficacy of soft tissue substitutes, in comparison with autogenous grafts, in surgical procedures aiming to increase the peri-implant keratinized mucosa: A systematic review. Clin Oral Implants Res. 2022 Jun;33 Suppl 23:32-46. doi: 10.1111/clr.13751.
PubMed 35763018Solonko M, Regidor E, Ortiz-Vigon A, Montero E, Vilchez B, Sanz M. Efficacy of keratinized mucosal augmentation with a collagen matrix concomitant to the surgical treatment of peri-implantitis: A dual-center randomized clinical trial. Clin Oral Implants Res. 2022 Jan;33(1):105-119. doi: 10.1111/clr.13870. Epub 2021 Oct 21.
PubMed 34651349Urban IA, Lozada JL, Nagy K, Sanz M. Treatment of severe mucogingival defects with a combination of strip gingival grafts and a xenogeneic collagen matrix: a prospective case series study. Int J Periodontics Restorative Dent. 2015 May-Jun;35(3):345-53. doi: 10.11607/prd.2287.
PubMed 25909521Molnar E, Molnar B, Lohinai Z, Toth Z, Benyo Z, Hricisak L, Windisch P, Vag J. Evaluation of Laser Speckle Contrast Imaging for the Assessment of Oral Mucosal Blood Flow following Periodontal Plastic Surgery: An Exploratory Study. Biomed Res Int. 2017;2017:4042902. doi: 10.1155/2017/4042902. Epub 2017 Jan 23.
PubMed 28232940
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strip Graft With Xenogeneic Matrix Versus Free Gingival Graft for the Augmentation of Peri-implant Keratinized Mucosa: A Randomized Clinical Trial With Vascular Analysis
- ClinicalTrials.gov ID
- NCT06261268
- Acronym / sponsor ID
- Strip vs FGG
- Keywords
- Strip graft, Free gingival graft, Peri-implant keratinized mucosa, Soft tissue augmentation, Early wound healing, Postoperative blood supply
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- 29 Jan 2024 (actual)
- Primary completion
- 9 Apr 2027 (estimated)
- Study completion
- 9 Apr 2027 (estimated)
- First posted
- 15 Feb 2024 (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 primary objective of this study is to compare changes in peri-implant keratinized mucosa (PIKM) following the application of apically repositioned flap (ARF) using a combination of a Strip graft and a Xenogeneic matrix, or with a free gingival graft (FGG), in implants in the second stage with <2 mm of PIKM.
Additionally, as a secondary objective, the investigators compare postoperative blood supply in both recipient and donor sites based on the type of graft obtained. Meanwhile, the investigators evaluate differences between the two groups concerning microcirculation values (perfusion units, PU), soft tissue thickness (STT), volume change, vestibular depth, as well as clinical, aesthetic, and patient-reported outcome measures (PROMS).
Detailed description
- BACKGROUND The importance of keratinized tissue around teeth and dental implants is a frequently investigated topic in the literature. The need for an adequate amount of peri-implant keratinized mucosa (PIKM), which is defined as a minimum width of 2 mm is demonstrated according to a recently published systematic review and consensus report. The standard of care in the PIKM augmentation is the apically repositioned flap (ARF) combined with a free gingival graft (FGG), as it represents a predictable and documented strategy to gain KT width. However, such technique implies the harvest of abundant autogenous grafts, and is frequently associated to sub-optimal aesthetic results due to the poor color mimicry of the grafted tissue. In light of such limitations, some alternatives based on the use of soft tissue substitutes have been proposed, with the aim of reducing surgical invasiveness through the avoidance of large autogenous grafts and improving aesthetic outcomes. Among those, the sole use of as xenogeneic collagen matrices (XCM) has been associated with promising clinical outcomes albeit with lesser KT width gains as compared to autogenous FGGs. Recently, a novel approach called the Strip Technique (ST) has been introduced, where the exposed periosteal bed of a ARF is covered with the combination of a xenogeneic collagen matrix and a 2-3 mm wide strip of autogenous free gingival graft, sutured at the apical border of the matrix. The rationale for this "combined grafting technique" stands on reducing surgical invasiveness and improving color mimicry through the use of a XCM, while providing a source of autogenous keratinizing cells in the apical border of the grafted area to promote better PIKM gains. Albeit this new approach seems promising, there is limited evidence regarding its clinical efficacy and there is a lack of knowledge regarding how the adoption of such combined approach affects the re-perfusion of the grafted tissue and the overall microvascular healing of the surgical site. Furthermore, the pattern of the revascularization of both the autologous grafts and the XCM requires further understanding. Most of our recent knowledge comes from classical animal studies that evaluated the microvascularization of FGG when placed over periosteum with microscopy. The postoperative blood supply of these free grafts is of key importance to their survival. Recently a new non-invasive technique has been introduced in the field of medicine and dentistry the Laser Speckle Contrast Imaging (LSCI) system, that provides further understanding on the dynamics of postoperative blood supply of the applied grafts and elucidate regarding the healing pattern of the strip combination technique.
- JUSTIFICATION There is a lack of knowledge regarding the clinical performance, the healing pattern and the dynamics of revascularization when performing apically repositioned flaps combined with either the autogenous strip-XCM technique or autogenous FGGs.
Results from this study could assess whether the strip-XCM technique represents a reliable, less invasive, and simplified alternative to autogenous FGGs for the increase of PIKM.
Moreover, it could provide additional knowledge regarding the healing and revascularization pattern of both strip-XCM and FGGs around dental implants, assessed through an innovative technology as Laser Speckle Perfusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized controlled equivalence clinical trial will be performed, with two parallel groups, a 1:1 allocation ratio, and a 12-month follow-up.
| Arm | Type | Receives |
|---|---|---|
| Strip graft with Mucograft | Experimental | Procedure: Strip graft with MucograftAn apically repositioned flap is prepared then, a free epithelialized gingival strip graft is harvested from the molar area of the palate and sutured to the apical part of the recipient area. A xenogeneic collagen matrix (Mucograft®. Geistlich Pharma AG, Wolhusen, Switzerland) covers the remaining uncovered part of the periosteal bed. |
| Free gingival graft | Active comparator | Procedure: Free gingival graftApically repositioned flap is prepared. An epithelialized free gingival graft is harvested from the molar area of the palate, and sutured to the recipient area |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients older than 18 years
- Short-span dental implants in the mandible at second stage with inadequate PIKM (<2 mm) with at least one adjacent tooth mesially
- Periodontally healthy patients with a pristine or reduced periodontium
- Plaque index (FMPS) less than 20%.
Key exclusion criteria (6 listed)
- Compromised general health status that contraindicates study procedures (≥ASA III);
- Drug or alcohol abuse;
- Smoking of > 10 cigarettes per day;
- Chronic use of corticosteroids, NSAIDs or immunomodulators (any type or dose);
- Pregnant or lactating women;
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 |
|---|---|---|
| Strip graft with MucograftAn apically repositioned flap is made in the vestibular region. The flap is then elevated with a split-thickness preparation, and the mucogingival junction will be repositioned apically and fixed with periosteal-anchored sutures. Then, a free epithelialized gingival strip graft will be harvested from the molar area of the palate. The "Strip" graft is sutured to the apical end of the recipient bed. The remaining uncovered part of the periosteal bed will be covered with a xenogeneic collagen matrix (Mucograft®. Geistlich Pharma AG, Wolhusen, Switzerland) fixed with simple interrupted and crossed sutures. The edges of the palatal wound (donor area) will be approximated with crossed sutures. | Procedure or surgery | Strip graft with Mucograft |
| Free gingival graftThe preparation of the apically repositioned flap and the recipient bed with its apico-coronal design and dimension is performed as in the test group. Subsequently, an epithelialized free gingival graft with the size of the entire recipient area with a thickness of 2 mm will be harvested from the molar area of the palate. The graft is sutured to the recipient periosteal bed using simple interrupted and crossed sutures. In the donor area, a collagen sponge is sutured to the wound by means of crossed sutures. | Procedure or surgery | Free gingival graft |
Primary outcome
Changes in peri-implant keratinized mucosa width (mm)
Time frame: Baseline, 1, 3, 6 and 12 months
the apico-coronal linear dimension of the buccal peri-implant keratinized mucosa (PIKM) will be measured with a UNC15 periodontal probe (Hu-Friedy manufacturing, Co., LLC, Chicago, USA) as the linear dimension of the buccal vestibule, from the buccal peri-implant mucosa margin to the mucogingival junction at the mid-buccal aspect of the treated implant and adjacent mesial tooth.
15 secondary outcomes
Vascularization (in Laser Speckle perfusion units [LSPU])
Time frame: pre-surgically, post-surgically at 4, 7, 10, 14 and 30 days, and at 3-6 and 12 months
Changes in soft tissue thickness (STT) (mm)
Time frame: Baseline, post-op, 1, 3, 6 and 12 months
Vestibule depth (VD) (mm)
Time frame: Pre-surgically, and at 30 days, 3-6 and 12 months
Probing pocket depth (PPD) (mm)
Time frame: pre-surgically, at 3, 6 and 12 months after surgery
Dehiscence (mm)
Time frame: post-surgically, at 3, 6 and 12 months after surgery
Full-mouth plaque score (FMPS)
Time frame: Baseline, 1 month, 3 months, 6 and 12 months
Volumetric changes
Time frame: Baseline, 14 days, 1 month, 3, 6 and 12 months
Patient reported outcome measures (PROMS)
Time frame: immediately after the surgery, 12 hours after the surgery, 1 day, 2, 3, 4, 5, 6, 7 days and 2 weeks after the surgery
Esthetic analysis
Time frame: 30-day, 3-, 6- and 12-month
Intra-surgical parameters
Time frame: During surgery
Intra-surgical time
Time frame: During the surgery
Demographic data
Time frame: Baseline
Anamnesis data
Time frame: Baseline, through study completion, an average of 1 year
Smoking habit
Time frame: Baseline, through study completion, an average of 1 year
Full-mouth bleeding score (FMBS) (%)
Time frame: Baseline, 1 month, 3 months, 6 and 12 months
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 22 Apr 2026.
- Background: PubMed 35763022Ramanauskaite A, Schwarz F, Sader R. Influence of width of keratinized tissue on the prevalence of peri-implant diseases: A systematic review and meta-analysis. Clin Oral Implants Res. 2022 Jun;33 Suppl 23:8-31. doi: 10.1111/clr.13766.
- Background: PubMed 35763021Sanz M, Schwarz F, Herrera D, McClain P, Figuero E, Molina A, Monje A, Montero E, Pascual A, Ramanauskaite A, Renouard F, Sader R, Schiegnitz E, Urban I, Heitz-Mayfield L. Importance of keratinized mucosa around dental implants: Consensus report of group 1 of the DGI/SEPA/Osteology Workshop. Clin Oral Implants Res. 2022 Jun;33 Suppl 23:47-55. doi: 10.1111/clr.13956.
- Background: PubMed 35763018Montero E, Molina A, Matesanz P, Monje A, Sanz-Sanchez I, Herrera D. Efficacy of soft tissue substitutes, in comparison with autogenous grafts, in surgical procedures aiming to increase the peri-implant keratinized mucosa: A systematic review. Clin Oral Implants Res. 2022 Jun;33 Suppl 23:32-46. doi: 10.1111/clr.13751.
- Background: PubMed 34651349Solonko M, Regidor E, Ortiz-Vigon A, Montero E, Vilchez B, Sanz M. Efficacy of keratinized mucosal augmentation with a collagen matrix concomitant to the surgical treatment of peri-implantitis: A dual-center randomized clinical trial. Clin Oral Implants Res. 2022 Jan;33(1):105-119. doi: 10.1111/clr.13870. Epub 2021 Oct 21.
- Background: PubMed 25909521Urban IA, Lozada JL, Nagy K, Sanz M. Treatment of severe mucogingival defects with a combination of strip gingival grafts and a xenogeneic collagen matrix: a prospective case series study. Int J Periodontics Restorative Dent. 2015 May-Jun;35(3):345-53. doi: 10.11607/prd.2287.
- Background: PubMed 28232940Molnar E, Molnar B, Lohinai Z, Toth Z, Benyo Z, Hricisak L, Windisch P, Vag J. Evaluation of Laser Speckle Contrast Imaging for the Assessment of Oral Mucosal Blood Flow following Periodontal Plastic Surgery: An Exploratory Study. Biomed Res Int. 2017;2017:4042902. doi: 10.1155/2017/4042902. Epub 2017 Jan 23.
- Institutional homepageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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 director
Universidad Complutense de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strip graft with Mucograft and Free gingival graft in people with Peri-Implantational Loss and Surgical Wound, 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 4 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: under way, not looking for participants, as of the sponsor's last update on 22 Apr 2026. 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?
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?
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?
Changes in peri-implant keratinized mucosa width (mm) (time frame: Baseline, 1, 3, 6 and 12 months). 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 NCT06261268, which also lists 6 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 22 Apr 2026.