Severe Atrophy of the Edentulous MaxillaNCT06105489

"Tunnel" Flap vs Trapezoidal Flap for Lateral Sinus Lift

A study testing Lateral Sinus Lift using tunnel flap technique and Lateral Sinus Lift using crestal incision flap in people with Severe Atrophy of the Edentulous Maxilla, run by Studio Dentistico Associato Sivolella at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Severe Atrophy of the Edentulous Maxilla
What is being tested?: Lateral Sinus Lift using tunnel flap technique and Lateral Sinus Lift using crestal incision flap
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteItaly
Study dates: 21 Oct 2022to 21 Oct 2026
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

severe illness
head and neck radiation therapy
chemotherapy
antiresorptive therapy
uncontrolled diabetes
uncontrolled periodontal disease

Show all 9Show fewer

smoking >10 cigarettes per day
facial or neck inflammatory or oncologic diseases
obliteration of sinus ostium and osteomeatal complex

Trial locations and contacts

1 site in 1 country.

Stefano Sivolella, DDS, PhD contact

0039 049 652821

stefano.sivolella@unipd.it

Dario Azeglio Castagna contact

00393498550779

dario.castagna@virgilio.it

Italy1 site, 1 recruiting

Studio Dentistico Associato Graiff e Sivolella
Padova, 35127
Stefano Sivolella, DDS, PhD, 0039 049 652821, stefano.sivolella@unipd.it
Stefano Sivolella, DDS, PhD
Recruiting

Other trials in Italy

About this study

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

Is the tunnel flap technique more suitable for lateral sinus lift than the trapezoidal flap technique in terms of post-operative symptoms?
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.

Conditions: Severe Atrophy of the Edentulous Maxilla
Being tested: Lateral Sinus Lift using tunnel flap technique, Lateral Sinus Lift using crestal incision flap
Keywords: Lateral sinus lift, Tunnel technique, Dental Implant, Patient Reported Outcome Measures, Bone Regeneration, Flap Design, Histology, Heterologous bone, Cone Beam Computed Tomography

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lateral Sinus Lift using tunnel flap techniqueProcedure or surgery
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.
Lateral Sinus Lift using crestal incision flapProcedure or surgery
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.

Study groups in NCT06105489
Study group	Role	What they receive
Tunnel flap design	Experimental	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. Receives: Procedure: Lateral Sinus Lift using tunnel flap technique
Trapezioidal flap design	Active comparator	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. Receives: Procedure: Lateral Sinus Lift using crestal incision flap

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: First week after sinus lift procedure

Secondary outcomes (4)

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.
Measured: 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
Measured: 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).
Measured: 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.
Measured: 6 months after implant procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Oct 202221 Oct 2026

First posted27 Oct 2023
Study start21 Oct 2022
Primary completion21 Oct 2024 (estimated)
Study completion21 Oct 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (22)Papers the sponsor has linked to this study.
Other trials for Severe Atrophy of the Edentulous MaxillaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Participants will be assigned to one of two study arms, a test arm and a control arm, for the entire duration of the study.
Masking: None (open label)
Enrolment: 36 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06105489
Sponsor's protocol ID: 20464
Status last verified: Oct 2023
First submitted: 8 Oct 2023
Last updated: 27 Oct 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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.
PubMed 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.
PubMed 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.
PubMed 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.
PubMed 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.
PubMed 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.
PubMed 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.
PubMed 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.
PubMed 18724852
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.
PubMed 25287252
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.
PubMed 27765427
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.
PubMed 27534916
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.
PubMed 28494033
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.
PubMed 31407430
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.
PubMed 29914159
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.
PubMed 6323657

Study at a glance

From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: "Tunnel" Flap vs Trapezoidal Flap for Lateral Sinus Lift: A Prospective Randomized Study
ClinicalTrials.gov ID: NCT06105489
Acronym / sponsor ID: 20464
Conditions: Severe Atrophy of the Edentulous Maxilla
Keywords: Lateral sinus lift, Tunnel technique, Dental Implant, Patient Reported Outcome Measures, Bone Regeneration, Flap Design, Histology, Heterologous bone
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 36 participants (estimated)
Lead sponsor: Studio Dentistico Associato SivolellaUniversity, hospital or other
Study start: 21 Oct 2022 (actual)
Primary completion: 21 Oct 2024 (estimated)
Study completion: 21 Oct 2026 (estimated)
First posted: 27 Oct 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Participants will be assigned to one of two study arms, a test arm and a control arm, for the entire duration of the study.

Arm	Type	Receives
Tunnel flap design	Experimental	Procedure: Lateral Sinus Lift using tunnel flap techniqueParticipants 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	Active comparator	Procedure: Lateral Sinus Lift using crestal incision flapParticipants 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (9 listed)

severe illness
head and neck radiation therapy
chemotherapy
antiresorptive therapy
uncontrolled diabetes

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Lateral Sinus Lift using tunnel flap techniqueThe 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.	Procedure or surgery	Tunnel flap design
Lateral Sinus Lift using crestal incision flapThe 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.	Procedure or surgery	Trapezioidal flap design

Primary outcome

Pain and discomfort on VAS scale at the 4th postoperative day
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).

4 secondary outcomes

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

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
Background: PubMed 6993637Boyne 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.
Background: PubMed 29569763Stacchi 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.
Background: PubMed 25196695Spinato 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.
Background: PubMed 21143532Soardi 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.
Background: PubMed 32233185Stacchi 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.
Background: PubMed 8393101Moy 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.
Background: PubMed 17716261Browaeys 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.
Background: PubMed 18724852Pjetursson 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.
Background: PubMed 25287252Kao 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.
Background: PubMed 27765427Silva 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.
Background: PubMed 27534916Danesh-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.
Background: PubMed 28494033Stacchi 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.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Stefano Sivolella, DDS, PhD contact

0039 049 652821

stefano.sivolella@unipd.it

Dario Azeglio Castagna contact

00393498550779

dario.castagna@virgilio.it

Stefano Sivolella, DDS, PhD principal investigator

Studio Dentistico Associato Sivolella

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Stefano Sivolella, DDS, PhD (0039 049 652821, stefano.sivolella@unipd.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain and discomfort on VAS scale at the 4th postoperative day (time frame: First week after sinus lift procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06105489, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2023; AzTrials last refreshed its copy on 6 Nov 2026.