"Tunnel" Flap vs Trapezoidal Flap for Lateral Sinus Lift
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lateral Sinus Lift using tunnel flap technique, Lateral Sinus Lift using crestal incision flap.
- Who it may be relevant to
- Registry conditions: Severe Atrophy of the Edentulous Maxilla. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
"Tunnel" Flap vs Trapezoidal Flap for Lateral Sinus Lift: A Prospective Randomized Study
Overview
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.
Interventions
- 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 membran - 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 re
Primary outcome measures
- Pain and discomfort on VAS scale at the 4th postoperative day [Time frame: First week after sinus lift procedure]
Secondary outcome measures (4)
- Times for surgical procedure [Time frame: During sinus lift procedure]
- Soft tissue healing after sinus lift [Time frame: 10 days and 40 days after sinus lift procedure]
- Sinus lift related complications [Time frame: During sinus lift procedure, 1, 10 and 40 days from procedure.]
- Graft healing after a 6 months period [Time frame: 6 months after implant procedure]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- Studio Dentistico Associato Graiff e Sivolella — Padova
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. PMID 6993637
- 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. PMID 29569763
- 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. PMID 25196695
- 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. PMID 21143532
- 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. PMID 32233185
- 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. PMID 8393101
- 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. PMID 17716261
- 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. PMID 18724852
Identifiers
NCT: NCT06105489 · 20464