Surgical Wound Clinical Trial
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).
Status | Recruiting |
Enrollment | 48 |
Est. completion date | July 15, 2025 |
Est. primary completion date | December 15, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - 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%. Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Spain | Complutense University | Madrid |
Lead Sponsor | Collaborator |
---|---|
Universidad Complutense de Madrid |
Spain,
Molnar 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. — View Citation
Montero 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. — View Citation
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. — View Citation
Sanz 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. — View Citation
Solonko 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. — View Citation
Urban 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Baseline, 1, 3, 6 and 12 months | |
Secondary | 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. | pre-surgically, post-surgically at 4, 7, 10, 14 and 30 days, and at 3-6 and 12 months | |
Secondary | 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). | Baseline, post-op, 1, 3, 6 and 12 months | |
Secondary | 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 | Pre-surgically, and at 30 days, 3-6 and 12 months | |
Secondary | 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. | pre-surgically, at 3, 6 and 12 months after surgery | |
Secondary | 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. | post-surgically, at 3, 6 and 12 months after surgery | |
Secondary | 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. | Baseline, 1 month, 3 months, 6 and 12 months | |
Secondary | 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. | Baseline, 14 days, 1 month, 3, 6 and 12 months | |
Secondary | 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. | immediately after the surgery, 12 hours after the surgery, 1 day, 2, 3, 4, 5, 6, 7 days and 2 weeks after the surgery | |
Secondary | 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. | 30-day, 3-, 6- and 12-month | |
Secondary | 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. | During surgery | |
Secondary | Intra-surgical time | Surgical time will be recorded. | During the surgery | |
Secondary | Demographic data | affiliation data (age and sex) is recorded. For age the birthdate is recorded. | Baseline | |
Secondary | Anamnesis data | previous medical history (systemic diseases, medication, allergies) | Baseline, through study completion, an average of 1 year | |
Secondary | Smoking habit | Smoking habit is recorded in number of cigarettes per day. | Baseline, through study completion, an average of 1 year | |
Secondary | 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. | Baseline, 1 month, 3 months, 6 and 12 months |
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