Studio Dentistico Associato Graiff e Sivolella
Padova, 35127, Italy
Location status: Recruiting
Location contact
Stefano Sivolella, DDS, PhD
CONTACT
Stefano Sivolella, DDS, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06105489
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Padova, 35127, Italy
Location status: Recruiting
Stefano Sivolella, DDS, PhD
CONTACT
Stefano Sivolella, DDS, PhD
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The surgical procedure will involve the following steps:
The surgical procedure will involve the following steps:
Time frame: 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).
Time frame: 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.
Time frame: 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 healing
Time frame: 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).
Time frame: 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.
Time frame: During implant insertion
Bone quality will be evaluated by means of Lekholm Zarb classification, ranging from D1 for dense cortical bone and D4 for fine trabecular bone.
Time frame: During implant insertion, 12 months after sinus lift (prosthetic loading), 24 months after sinus lift
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.
Time frame: During implant insertion
Maximum insertion torque will be collected
Time frame: During implant insertion, 12 months after sinus lift (prosthetic loading), 24 months after sinus lift
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.)
Contact information is provided by the study sponsor or research team.
Dario Azeglio Castagna
CONTACT
Stefano Sivolella, DDS, PhD
CONTACT
Studio Dentistico Associato Sivolella
Other
"Tunnel" Flap vs Trapezoidal Flap for Lateral Sinus Lift: A Prospective Randomized Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.