"Tunnel" Flap vs Trapezoidal Flap for Lateral Sinus Lift

"Tunnel" Flap vs Trapezoidal Flap for Lateral Sinus Lift: A Prospective Randomized Study

The goal of this clinical trial is to evaluate the efficacy of the lateral sinus lift procedure using the tunnel technique flap in comparison to the traditional lateral sinus lift in partially or totally edentulous patients with loss of teeth in the maxillary premolar or molar areas and severe alveolar atrophy. The primary questions it aims to answer are:

1. Is the tunnel flap technique more suitable for lateral sinus lift than the trapezoidal flap technique in terms of post-operative symptoms?
2. Is the tunnel technique safer and more effective than the trapezoidal flap technique in terms of complication rate and the effectiveness of bone grafting?

Participants will undergo the lateral sinus lift procedure using the tunnel technique, which involves making a vertical anterior incision. Patients will receive follow-up care, including phone contact the day after the procedure to detect any issues, and they will keep a diary during the week after surgery to record visual analog scale (VAS) pain values and analgesics taken. Follow-up surgical visits will be scheduled for suture removal and at 30 days after suture removal. After 6 months, dental implants will be inserted, and prosthetic rehabilitation will take place 6 months later. Implants will be monitored for up to 12 months after prosthetic rehabilitation.

Researchers will compare the outcomes of tunnel flap technique lateral sinus lift with the trapezoidal flap sinus lift.

Study Overview

• Status: Recruiting
• Conditions: Severe Atrophy of the Edentulous Maxilla
• Intervention / Treatment: Procedure: Lateral Sinus Lift using tunnel flap technique; Procedure: Lateral Sinus Lift using crestal incision flap

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stefano Sivolella, DDS, PhD; Phone Number: 0039 049 652821; Email: stefano.sivolella@unipd.it
• Study Contact Backup: Name: Dario Azeglio Castagna; Phone Number: 00393498550779; Email: dario.castagna@virgilio.it

Study Locations

• Italy
  • Padova, Italy, 35127
    • Recruiting
    • Studio Dentistico Associato Graiff e Sivolella
    • Contact: Stefano Sivolella, DDS, PhD; Phone Number: 0039 049 652821; Email: stefano.sivolella@unipd.it
    • Principal Investigator: Stefano Sivolella, DDS, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• edentulous or partly edentulous patients with a unilateral loss of teeth in the maxillary premolar or molar areas
• severe alveolar atrophy and a residual severe alveolar ridge height up to 3 mm

Exclusion Criteria:

• severe illness
• head and neck radiation therapy
• chemotherapy
• antiresorptive therapy
• uncontrolled diabetes
• uncontrolled periodontal disease
• smoking >10 cigarettes per day
• facial or neck inflammatory or oncologic diseases
• obliteration of sinus ostium and osteomeatal complex

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tunnel flap design; Participants will undergo a lateral sinus lift procedure in which a single vertical anterior incision will be made at least 10 mm mesially to the expected outline of the bony window.	Procedure: Lateral Sinus Lift using tunnel flap technique; The surgical procedure will involve the following steps: A single vertical anterior incision will be made, at least 10 mm mesially to the expected outline of the bony window.; A full-thickness flap will be carefully elevated to expose the lateral wall of the maxillary sinus.; A trap door will be created in the lateral wall of the maxillary sinus using either a dedicated piezosurgical insert or a straight handpiece with a 3mm round diamond bur.; The door will be removed.; The sinus membrane will be gently elevated using various-shaped curettes until it becomes completely detached from the lateral, inferior, and medial walls of the sinus.; The maxillary sinus will be filled with a heterologous bone graft with a well-documented efficacy.; The flaps will be meticulously sutured.
Active Comparator: Trapezioidal flap design; Participants will undergo a lateral sinus lift procedure. The incision will be made horizontally on the top of the alveolar ridge, with two additional releasing incisions in the mesial and distal regions.	Procedure: Lateral Sinus Lift using crestal incision flap; The surgical procedure will involve the following steps: A horizontal incision is made on the top of the alveolar ridge, along with two additional releasing incisions in the mesial and distal regions.; A full-thickness flap will be carefully elevated to expose the lateral wall of the maxillary sinus.; A trap door will be created in the lateral wall of the maxillary sinus using either a dedicated piezosurgical insert or a straight handpiece with a 3mm round diamond bur.; The door will be removed.; The sinus membrane will be gently elevated using various-shaped curettes until it becomes completely detached from the lateral, inferior, and medial walls of the sinus.; The maxillary sinus will be filled with a heterologous bone graft with a well-documented efficacy.; The flaps will be meticulously sutured.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain and discomfort on VAS scale at the 4th postoperative day	Participants will record the subjective post-operative pain/discomfort on a daily VAS score (0 to 10) for the first 7 days, at the same time each day, on a specific form. The VAS is a horizontal ruler 10 cm long with the left end (0 cm) indicating "no pain/discomfort at all" and the right limit (10 cm) indicating "the worst pain imaginable. Patients will be also asked to record the need for analgesics (including type and quantity).	First week after sinus lift procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Times for surgical procedure	Surgical intervention duration (minutes) recorded from incision to the last suture (T1). Times for sinus mucosa elevation (T2) and for sinus filling (T3) will be measured as well.	During sinus lift procedure
Soft tissue healing after sinus lift	Soft tissue healing will be evaluated using the scoring reported by Lin SL et al., at two timepoints: at suture removal and at 30 days after suture removal control. Assessments of wound healing will include 6 scoring categories, namely erythema, exudate, epithelialization, mucosa color, wound contour, and distortion of mucosa. Each category is scored on a 3-point scale (0, 1, or 2) and a total score from 0 to 3 represents good healing, a score from 4 to 6 represents satisfactory healing, a score from 7 to 9 represents disturbance of healing, and a score from 10 to 12 represents poor healing	10 days and 40 days after sinus lift procedure
Sinus lift related complications	Possible complications will be evaluated at various timepoints. During the surgical procedure through direct observation (bleeding, sinus membrane perforation, infraorbital nerve injury, perforation of the flap). The day after surgery through a telephone call to the patient (bleeding, flap dehiscence, hematoma, pain). At suture removal control after 10 +/- days after surgery (pain, infections, sinusitis, bone graft displacement, neuropathy, wound dehiscence). At 30 days after suture removal control (pain, infections, sinusitis, bone graft displacement, neuropathy).	During sinus lift procedure, 1, 10 and 40 days from procedure.
Graft healing after a 6 months period	A CBCT of the grafted area finalized to implants insertion planning will be taken after 6 months from the sinus lift. The parameters evaluated will be the final alveolar bone graft height calculated in correspondence of a line passing through the centre of the previous bone window; the presence of the contact between the bone graft and the medial or nasal wall of the sinus cavity; the regular distribution of the graft, intended as the presence of voids or displacements. Moreover a biopsy will be taken during implants insertion by means of a trefine.	6 months after implant procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone quality	Bone quality will be evaluated by means of Lekholm Zarb classification, ranging from D1 for dense cortical bone and D4 for fine trabecular bone.	During implant insertion
ISQ and RFA	ISQ, ranging from 1 to 100, will be evaluated measuring RFA on two axis (palatal-buccal and mesial-distal) and their mean value will be collected.	During implant insertion, 12 months after sinus lift (prosthetic loading), 24 months after sinus lift
Insertion torque	Maximum insertion torque will be collected	During implant insertion
Peri-implant marginal bone	Peri-implant marginal bone variations (mm) will be measured on Periapical radiograph with a standardized technique will be obtained, using methods already described Marginal bone stability (eg Mameno, Tomoaki, et al. "Risk indicators for marginal bone resorption around implants in function for at least 4 years: A retrospective longitudinal study."Journal of periodontology 91.1 (2020): 37-45.)	During implant insertion, 12 months after sinus lift (prosthetic loading), 24 months after sinus lift

Collaborators and Investigators

• Sponsor: Studio Dentistico Associato Sivolella
• Investigators: Principal Investigator: Stefano Sivolella, DDS, PhD, Studio Dentistico Associato Sivolella

Publications and helpful links

General Publications

• Boyne PJ, James RA. Grafting of the maxillary sinus floor with autogenous marrow and bone. J Oral Surg. 1980 Aug;38(8):613-6. No abstract available.
• Stacchi C, Lombardi T, Ottonelli R, Berton F, Perinetti G, Traini T. New bone formation after transcrestal sinus floor elevation was influenced by sinus cavity dimensions: A prospective histologic and histomorphometric study. Clin Oral Implants Res. 2018 May;29(5):465-479. doi: 10.1111/clr.13144. Epub 2018 Mar 23.
• Pjetursson BE, Tan WC, Zwahlen M, Lang NP. A systematic review of the success of sinus floor elevation and survival of implants inserted in combination with sinus floor elevation. J Clin Periodontol. 2008 Sep;35(8 Suppl):216-40. doi: 10.1111/j.1600-051X.2008.01272.x.
• Rothstein SS, Paris DA, Zacek MP. Use of hydroxylapatite for the augmentation of deficient alveolar ridges. J Oral Maxillofac Surg. 1984 Apr;42(4):224-30. doi: 10.1016/0278-2391(84)90453-1.
• Stacchi C, Andolsek F, Berton F, Perinetti G, Navarra CO, Di Lenarda R. Intraoperative Complications During Sinus Floor Elevation with Lateral Approach: A Systematic Review. Int J Oral Maxillofac Implants. 2017 May/Jun;32(3):e107-e118. doi: 10.11607/jomi.4884.
• Spinato S, Bernardello F, Galindo-Moreno P, Zaffe D. Maxillary sinus augmentation by crestal access: a retrospective study on cavity size and outcome correlation. Clin Oral Implants Res. 2015 Dec;26(12):1375-82. doi: 10.1111/clr.12477. Epub 2014 Sep 5.
• Soardi CM, Spinato S, Zaffe D, Wang HL. Atrophic maxillary floor augmentation by mineralized human bone allograft in sinuses of different size: an histologic and histomorphometric analysis. Clin Oral Implants Res. 2011 May;22(5):560-6. doi: 10.1111/j.1600-0501.2010.02034.x. Epub 2010 Dec 9.
• Stacchi C, Spinato S, Lombardi T, Bernardello F, Bertoldi C, Zaffe D, Nevins M. Minimally Invasive Management of Implant-Supported Rehabilitation in the Posterior Maxilla, Part II. Surgical Techniques and Decision Tree. Int J Periodontics Restorative Dent. 2020 May/Jun;40(3):e95-e102. doi: 10.11607/prd.4498.
• Moy PK, Lundgren S, Holmes RE. Maxillary sinus augmentation: histomorphometric analysis of graft materials for maxillary sinus floor augmentation. J Oral Maxillofac Surg. 1993 Aug;51(8):857-62. doi: 10.1016/s0278-2391(10)80103-x.
• Browaeys H, Bouvry P, De Bruyn H. A literature review on biomaterials in sinus augmentation procedures. Clin Implant Dent Relat Res. 2007 Sep;9(3):166-77. doi: 10.1111/j.1708-8208.2007.00050.x.
• Kao SY, Lui MT, Cheng DH, Chen TW. Lateral trap-door window approach with maxillary sinus membrane lifting for dental implant placement in atrophied edentulous alveolar ridge. J Chin Med Assoc. 2015 Feb;78(2):85-8. doi: 10.1016/j.jcma.2014.05.016. Epub 2014 Oct 3.
• Silva LD, de Lima VN, Faverani LP, de Mendonca MR, Okamoto R, Pellizzer EP. Maxillary sinus lift surgery-with or without graft material? A systematic review. Int J Oral Maxillofac Surg. 2016 Dec;45(12):1570-1576. doi: 10.1016/j.ijom.2016.09.023. Epub 2016 Oct 17.
• Danesh-Sani SA, Engebretson SP, Janal MN. Histomorphometric results of different grafting materials and effect of healing time on bone maturation after sinus floor augmentation: a systematic review and meta-analysis. J Periodontal Res. 2017 Jun;52(3):301-312. doi: 10.1111/jre.12402. Epub 2016 Aug 18.
• Testori T, Weinstein T, Taschieri S, Wallace SS. Risk factors in lateral window sinus elevation surgery. Periodontol 2000. 2019 Oct;81(1):91-123. doi: 10.1111/prd.12286.
• Scarano A, Lorusso F, Arcangelo M, D'Arcangelo C, Celletti R, de Oliveira PS. Lateral Sinus Floor Elevation Performed with Trapezoidal and Modified Triangular Flap Designs: A Randomized Pilot Study of Post-Operative Pain Using Thermal Infrared Imaging. Int J Environ Res Public Health. 2018 Jun 16;15(6):1277. doi: 10.3390/ijerph15061277.
• De Stavola L, Tunkel J. Results of vertical bone augmentation with autogenous bone block grafts and the tunnel technique: a clinical prospective study of 10 consecutively treated patients. Int J Periodontics Restorative Dent. 2013 Sep-Oct;33(5):651-9. doi: 10.11607/prd.0932.
• Restoy-Lozano A, Dominguez-Mompell JL, Infante-Cossio P, Lara-Chao J, Espin-Galvez F, Lopez-Pizarro V. Reconstruction of mandibular vertical defects for dental implants with autogenous bone block grafts using a tunnel approach: clinical study of 50 cases. Int J Oral Maxillofac Surg. 2015 Nov;44(11):1416-22. doi: 10.1016/j.ijom.2015.05.019. Epub 2015 Jun 23.
• Khoury F, Hanser T. Three-Dimensional Vertical Alveolar Ridge Augmentation in the Posterior Maxilla: A 10-year Clinical Study. Int J Oral Maxillofac Implants. 2019 Mar/Apr;34(2):471-480. doi: 10.11607/jomi.6869.
• Ponte A, Khoury F. The tunnel technique in bone grafting procedure: A clinical study. Int J Oral Maxxillofac Implants. 2004; 19: 766.
• Mazzocco C, Buda S, De Paoli S. The tunnel technique: a different approach to block grafting procedures. Int J Periodontics Restorative Dent. 2008 Feb;28(1):45-53.
• Restoy A, Pizarro VL, Ordonez V, Lara J, Doussinague BR, Dominguez-Mompell JL. Treatment of the posterior atrophic maxilla using three-dimensional reconstruction technique with sinus lift and a "tunnel" approach. Rev Esp Cir Oral Maxilofac. 2015;37:7-14
• Lin SL, Wu SL, Tsai CC, Ko SY, Chiang WF, Yang JW. The Use of Solid-Phase Concentrated Growth Factors for Surgical Defects in the Treatment of Dysplastic Lesions of the Oral Mucosa. J Oral Maxillofac Surg. 2016 Dec;74(12):2549-2556. doi: 10.1016/j.joms.2016.06.183. Epub 2016 Jul 1.

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2022
• Primary Completion (Estimated): October 21, 2024
• Study Completion (Estimated): October 21, 2026

Study Registration Dates

• First Submitted: October 8, 2023
• First Submitted That Met QC Criteria: October 23, 2023
• First Posted (Actual): October 27, 2023

Study Record Updates

• Last Update Posted (Actual): October 27, 2023
• Last Update Submitted That Met QC Criteria: October 23, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Dental Implant; Patient Reported Outcome Measures; Histology; Bone Regeneration; Cone Beam Computed Tomography; Lateral sinus lift; Tunnel technique; Flap Design; Heterologous bone
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy
• Other Study ID Numbers: 20464

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes