Tooth LossSmartLiftRERNCT02415946
Sinus Lift: Saving Time and Reducing Morbidity
A study testing Sinus floor augmentation (lateral) and Sinus floor augmentation (transcrestal) in people with Tooth Loss and Bone Atrophy, run by University Hospital of Ferrara at 2 sites in Italy.
Trial summary
BACKGROUND Tooth loss impairs the OHRQoL. Dental implants have expanded treatment options of edentulous patients and improved their OHRQoL, however, in the posterior maxillary sextants the possibility to place implants of desired length and diameter could be limited. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tooth Loss, Bone Atrophy
- What is being tested?
- Sinus floor augmentation (lateral) and Sinus floor augmentation (transcrestal)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 2 sitesItaly
- Study dates
- Feb 2015to Jan 2018
- 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
- Patient-specific
- age≥ 21 years;
- good physical status (ASA1 and ASA2 according to Physical Status Classification System) (American Society of Anesthesiologists);
- systemic and local conditions compatible with implant placement and sinus floor elevation procedures;
- indication to a fixed, implant-supported prosthetic rehabilitation with sinus floor elevation as part of the comprehensive oral rehabilitation plan;
- patient willing and fully capable to comply with the study protocol.
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- Site-specific For a site to be considered as experimental (and thus included for analysis), the following criteria must be fulfilled:
- at least 6 months elapsed from tooth/teeth loss;
- residual bone height (as radiographically assessed) ≥3 mm and ≤6 mm;
- receiving an implant 3.5 ÷ 5 mm wide, ≥ 8 mm long and at least 5 mm longer than the residual bone height.
Who cannot join
- current heavy smoking (≥ 20 cigarettes/day for ≥ 6 months prior to and at the time of the surgical procedure);
- untreated periodontal disease prior to implant placement;
- history of radiation therapy in the head and neck area;
- history of chemotherapy;
- systemic disease or conditions with a documented effect on bone metabolism and/or osseous healing;
- past (within 6 months prior to enrollment in the study) or current treatment with any medication with a documented effect on bone metabolism and/or osseous healing;
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- physical or mental handicap that can interfere with adherence to the study procedures and adequate hygienic compliance;
- documented allergy to dental materials involved in the experimental protocol;
- pregnancy or lactation;
- history of drug or alcohol abuse.
- Moreover, participants will be exited from the study immediately upon:
- request to withdraw from further participation;
- development of acute dental, peri-implant or oral conditions requiring treatment;
- development of conditions conflicting with the exclusion criteria listed above;
- failure to comply with study instructions/requirements.
- Site-specific
- presence of endodontic lesions at teeth adjacent to the implant site;
- previous bone augmentation/preservation procedures at the designated implant areas;
- diagnosis of maxillary sinusitis at the experimental quadrant;
- need for concomitant lateral/vertical bone reconstructive procedures other than maxillary sinus floor elevation.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Efficacy of a Novel Simplified, Minimally-invasive Procedure for Sinus Floor Elevation in the Atrophic Posterior Maxilla: a Multicenter, Randomized Study
BACKGROUND Tooth loss impairs the OHRQoL. Dental implants have expanded treatment options of edentulous patients and improved their OHRQoL, however, in the posterior maxillary sextants the possibility to place implants of desired length and diameter could be limited. lSFE and tSFE represent two surgical options to vertically enhance the available bone in the edentulous posterior maxilla. Invasivity, relevant postoperative discomfort, high costs, and long times needed for the finalization of the prosthetic rehabilitation, however, strongly limit the indications of lSFE and support the need for less traumatic procedures with similar clinical effectiveness and reduced morbidity. In 2008, the investigators proposed a user-friendly, safe, predictable and effective minimally-invasive procedure for tSFE, namely the Smart Lift technique.
AIMS/OBJECTIVES The general aim of the present project is to validate the Smart Lift technique as a simplified and minimally-invasive procedure for the implant-supported rehabilitation of patients with edentulous, atrophic maxillary posterior sextants.
Read more
METHODS In a multicenter RCT study design, the reconstructive (clinical) and patient-centered outcomes of tSFE performed according to the Smart Lift technique will be compared with those of conventional lSFE.
EXPECTED RESULTS The Smart Lift technique should allow for a significant reduction of treatment time, post-surgery complications and costs and an increase in the satisfaction perceived by the edentulous patient with implant-supported rehabilitation, while maintaining a clinical efficacy as well as a similar or lower morbidity and discomfort when compared to lSFE. In other words, the investigators expect that more favorable risk-benefit and cost-utility ratio, as well as a better performance in terms of pain, comfort, physical, social and psychological effects of oral health, and issues concerning the OHRQoL, will be observed for the Smart Lift technique compared to lSFE.
List of Acronyms (in alphabetical order) OHRQoL: Oral Health - Related Quality of Life lSFE: sinus floor elevation with a lateral approach RCT: randomized controlled trial tSFE: sinus floor elevation with transcrestal approach
- Conditions
- Tooth Loss, Bone Atrophy
- Being tested
- Sinus floor augmentation (lateral), Sinus floor augmentation (transcrestal)
- Keywords
- regenerative medicine, bone substitutes, sinus floor augmentation
- Medical subject headings
- Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sinus floor augmentation (lateral)Procedure or surgery
Sinus floor augmentation (transcrestal)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Sinus floor augmentation (lateral) | Active comparator | Maxillary sinus floor elevation using a lateral approach Receives: Procedure: Sinus floor augmentation (lateral) |
| Sinus floor augmentation (transcrestal) | Experimental | Maxillary sinus floor elevation using a transcrestal approach (Smart Lift technique; Trombelli et al. 2008) Receives: Procedure: Sinus floor augmentation (transcrestal) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vertical extent of sinus lift
At each observation interval, the vertical extent of sinus lift will be measured as the distance (in mm) between the sinus floor and the most apical portion of the radiopaque area in the mid CT/CBCT section including the implant.
Measured: week +48
Secondary outcomes (8)
Implant survival
At each observation interval, implant survival will be recorded as the persistence of the implant in the oral cavity with absence of mobility (defined as the absence of vertical, lateral and rotational movements of the implant). When evaluating multiple implants splinted by prosthetic restorations, all implants supporting the prosthesis will be considered as failed or survived if the prosthesis is mobile or not mobile, respectively.
Measured: week +48
Type and incidence of surgical and post-surgical complications
The incidence of membrane perforation will be evaluated by the Valsalva maneuver (for tSFE) or visually (for lSFE). Other surgical or post-surgical complications associated with the sinus lift procedure, including Benign Paroxysmal Positional Vertigo (BPPV), post-operative infection, post-operative haemorrhage, nasal bleeding, blocked nose, either assessed by the operator or reported by the patient, will be also recorded.
Measured: week +48
Level of post-operative pain
The level of pain perceived by the patient (VASpain) will be recorded daily (evening) for 14 days following surgery on a 100-mm visual analogue scale (VAS) (ranging from "0 - no pain" to "100 - intolerable pain").
Measured: week +2
type and dosage of post-surgery medications
The patient will self-report the dosage of rescue anti-inflammatory drug (i.e. number of ibuprofen 600 mg tablets) assumed from the 1st to the 14th postoperative day, as well as the assumption of other types of drugs (e.g. antibiotics).
Measured: week +2
Costs arised from the realization of the surgical procedure and during the postoperative period
Costs arised (i) from the realization of the surgical procedure (e.g., pre-operative exams, materials), and (ii) during the postoperative period (e.g., patient post-surgical monitoring, management of post-surgical complications, and limitations in daily activities caused by surgery) will be evaluated for each patient.
Rather than with monetary units, costs will be compared between treatment groups using tSFE/lSFE ratios.
Measured: week +48
radiographic height of the graft over the implant apex
The height of the graft apical to the implant apex will be measured as the distance (in mm) occupied by a radiopaque area between the implant apex and the sinus floor as assessed at the mid portion of the implant on the mid CT/CBCT section including the implant.
Measured: week +48
General health-related quality of life as assessed by the Short Form Health Survey (SF-36) questionnaire
A validated, self-administered questionnaire will be used to assess the general health - related quality of life (GHrQoL) immediately before surgery and at week +48. To assess GHrQoL, the Short Form health survey (SF-36) questionnaire (Ware \& Sherbourne 1992) will be used.
Measured: day 0, week +48
Oral health-related quality of life as assessed by the Oral Health Impact Profile (OHIP-20) questionnaire
A validated, self-administered questionnaire will be used to assess the oral health - related quality of life (OHrQoL) immediately before surgery and at week +48. To assess OHrQoL, the Oral Health Impact Profile (OHIP)-20 questionnaire (Allen \& Locker 2002, Awad et al. 2003) will be used.
Measured: day 0, week +48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2015 (estimated)
- Study startFeb 2015
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Tooth LossStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Ferrara
- Sponsor type
- University, hospital or other
- Collaborators
- University of Modena and Reggio Emilia
- Responsible party
- Principal investigator, Roberto Farina, University Hospital of Ferrara
- Investigators
- Roberto Farina, Researcher, Principal investigator, Research Centre for the Study of Periodontal and Peri-implant Diseases, University of Ferrara, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02415946
- Sponsor's protocol ID
- PRUA1GR-2013-00000168
- Acronym
- SmartLiftRER
- Status last verified
- Feb 2018
- First submitted
- 2 Dec 2014
- Last updated
- 26 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Farina R, Simonelli A, Franceschetti G, Minenna L, Schincaglia GP, Riccardi O, Trombelli L. Peri-implant tissue conditions following transcrestal and lateral sinus floor elevation: 3-year results of a bi-center, randomized trial. Clin Oral Investig. 2022 May;26(5):3975-3986. doi: 10.1007/s00784-021-04364-y. Epub 2022 Jan 10.
PubMed 35013782Farina R, Franceschetti G, Travaglini D, Consolo U, Minenna L, Schincaglia GP, Riccardi O, Bandieri A, Maietti E, Trombelli L. Radiographic outcomes of transcrestal and lateral sinus floor elevation: One-year results of a bi-center, parallel-arm randomized trial. Clin Oral Implants Res. 2019 Sep;30(9):910-919. doi: 10.1111/clr.13497. Epub 2019 Jul 10.
PubMed 31240743Farina R, Franceschetti G, Travaglini D, Consolo U, Minenna L, Schincaglia GP, Riccardi O, Bandieri A, Maietti E, Trombelli L. Morbidity following transcrestal and lateral sinus floor elevation: A randomized trial. J Clin Periodontol. 2018 Sep;45(9):1128-1139. doi: 10.1111/jcpe.12985. Epub 2018 Aug 3.
PubMed 29992594
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Novel Simplified, Minimally-invasive Procedure for Sinus Floor Elevation in the Atrophic Posterior Maxilla: a Multicenter, Randomized Study
- ClinicalTrials.gov ID
- NCT02415946
- Acronym / sponsor ID
- SmartLiftRER / PRUA1GR-2013-00000168
- Conditions
- Tooth Loss, Bone Atrophy
- Keywords
- regenerative medicine, bone substitutes, sinus floor augmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University Hospital of FerraraUniversity, hospital or other
- Collaborators
- University of Modena and Reggio Emilia
- Study start
- Feb 2015 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 14 Apr 2015 (estimated)
- 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.
BACKGROUND Tooth loss impairs the OHRQoL. Dental implants have expanded treatment options of edentulous patients and improved their OHRQoL, however, in the posterior maxillary sextants the possibility to place implants of desired length and diameter could be limited. lSFE and tSFE represent two surgical options to vertically enhance the available bone in the edentulous posterior maxilla. Invasivity, relevant postoperative discomfort, high costs, and long times needed for the finalization of the prosthetic rehabilitation, however, strongly limit the indications of lSFE and support the need for less traumatic procedures with similar clinical effectiveness and reduced morbidity. In 2008, the investigators proposed a user-friendly, safe, predictable and effective minimally-invasive procedure for tSFE, namely the Smart Lift technique.
AIMS/OBJECTIVES The general aim of the present project is to validate the Smart Lift technique as a simplified and minimally-invasive procedure for the implant-supported rehabilitation of patients with edentulous, atrophic maxillary posterior sextants.
METHODS In a multicenter RCT study design, the reconstructive (clinical) and patient-centered outcomes of tSFE performed according to the Smart Lift technique will be compared with those of conventional lSFE.
EXPECTED RESULTS The Smart Lift technique should allow for a significant reduction of treatment time, post-surgery complications and costs and an increase in the satisfaction perceived by the edentulous patient with implant-supported rehabilitation, while maintaining a clinical efficacy as well as a similar or lower morbidity and discomfort when compared to lSFE. In other words, the investigators expect that more favorable risk-benefit and cost-utility ratio, as well as a better performance in terms of pain, comfort, physical, social and psychological effects of oral health, and issues concerning the OHRQoL, will be observed for the Smart Lift technique compared to lSFE.
List of Acronyms (in alphabetical order) OHRQoL: Oral Health - Related Quality of Life lSFE: sinus floor elevation with a lateral approach RCT: randomized controlled trial tSFE: sinus floor elevation with transcrestal approach
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sinus floor augmentation (lateral) | Active comparator | Procedure: Sinus floor augmentation (lateral)Maxillary sinus floor elevation using a lateral approach |
| Sinus floor augmentation (transcrestal) | Experimental | Procedure: Sinus floor augmentation (transcrestal)Maxillary sinus floor elevation using a transcrestal approach (Smart Lift technique; Trombelli et al. 2008) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient-specific
- age≥ 21 years;
- good physical status (ASA1 and ASA2 according to Physical Status Classification System) (American Society of Anesthesiologists);
- systemic and local conditions compatible with implant placement and sinus floor elevation procedures;
- indication to a fixed, implant-supported prosthetic rehabilitation with sinus floor elevation as part of the comprehensive oral rehabilitation plan;
Key exclusion criteria (20 listed)
- current heavy smoking (≥ 20 cigarettes/day for ≥ 6 months prior to and at the time of the surgical procedure);
- untreated periodontal disease prior to implant placement;
- history of radiation therapy in the head and neck area;
- history of chemotherapy;
- systemic disease or conditions with a documented effect on bone metabolism and/or osseous healing;
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 |
|---|---|---|
| Sinus floor augmentation (lateral) | Procedure or surgery | Sinus floor augmentation (lateral) |
| Sinus floor augmentation (transcrestal) | Procedure or surgery | Sinus floor augmentation (transcrestal) |
Primary outcome
Vertical extent of sinus lift
Time frame: week +48
At each observation interval, the vertical extent of sinus lift will be measured as the distance (in mm) between the sinus floor and the most apical portion of the radiopaque area in the mid CT/CBCT section including the implant.
8 secondary outcomes
Implant survival
Time frame: week +48
Type and incidence of surgical and post-surgical complications
Time frame: week +48
Level of post-operative pain
Time frame: week +2
type and dosage of post-surgery medications
Time frame: week +2
Costs arised from the realization of the surgical procedure and during the postoperative period
Time frame: week +48
radiographic height of the graft over the implant apex
Time frame: week +48
General health-related quality of life as assessed by the Short Form Health Survey (SF-36) questionnaire
Time frame: day 0, week +48
Oral health-related quality of life as assessed by the Oral Health Impact Profile (OHIP-20) questionnaire
Time frame: day 0, week +48
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2018.
- Derived from this study: PubMed 35013782Farina R, Simonelli A, Franceschetti G, Minenna L, Schincaglia GP, Riccardi O, Trombelli L. Peri-implant tissue conditions following transcrestal and lateral sinus floor elevation: 3-year results of a bi-center, randomized trial. Clin Oral Investig. 2022 May;26(5):3975-3986. doi: 10.1007/s00784-021-04364-y. Epub 2022 Jan 10.
- Derived from this study: PubMed 31240743Farina R, Franceschetti G, Travaglini D, Consolo U, Minenna L, Schincaglia GP, Riccardi O, Bandieri A, Maietti E, Trombelli L. Radiographic outcomes of transcrestal and lateral sinus floor elevation: One-year results of a bi-center, parallel-arm randomized trial. Clin Oral Implants Res. 2019 Sep;30(9):910-919. doi: 10.1111/clr.13497. Epub 2019 Jul 10.
- Derived from this study: PubMed 29992594Farina R, Franceschetti G, Travaglini D, Consolo U, Minenna L, Schincaglia GP, Riccardi O, Bandieri A, Maietti E, Trombelli L. Morbidity following transcrestal and lateral sinus floor elevation: A randomized trial. J Clin Periodontol. 2018 Sep;45(9):1128-1139. doi: 10.1111/jcpe.12985. Epub 2018 Aug 3.
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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.
Roberto Farina, Researcher principal investigator
Research Centre for the Study of Periodontal and Peri-implant Diseases, University of Ferrara, Italy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sinus floor augmentation (lateral) and Sinus floor augmentation (transcrestal) in people with Tooth Loss and Bone Atrophy, run by University Hospital of Ferrara at 2 sites in Italy.
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 10 inclusion and 20 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: finished, as of the sponsor's last update on 26 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vertical extent of sinus lift (time frame: week +48). 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 NCT02415946, which also lists 3 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 26 Feb 2018.