"Tunnel" Flap vs Trapezoidal Flap for Lateral Sinus Lift
- Conditions
- Severe Atrophy of the Edentulous Maxilla
- Interventions
- Procedure: Lateral Sinus Lift using tunnel flap techniqueProcedure: Lateral Sinus Lift using crestal incision flap
- Registration Number
- NCT06105489
- Lead Sponsor
- Studio Dentistico Associato Sivolella
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 36
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tunnel flap design Lateral Sinus Lift using tunnel flap technique 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. Trapezioidal flap design Lateral Sinus Lift using crestal incision flap 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.
- Primary Outcome Measures
Name Time Method Pain and discomfort on VAS scale at the 4th postoperative day First week after sinus lift procedure 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).
- Secondary Outcome Measures
Name Time Method Times for surgical procedure During sinus lift 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.
Soft tissue healing after sinus lift 10 days and 40 days after sinus lift procedure 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 healingSinus lift related complications During sinus lift procedure, 1, 10 and 40 days from procedure. 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).
Graft healing after a 6 months period 6 months after implant procedure 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.
Trial Locations
- Locations (1)
Studio Dentistico Associato Graiff e Sivolella
🇮🇹Padova, Italy