Sinus Lift: Saving Time and Reducing Morbidity

NCT02415946 | Completed

• 1 other identifier: PRUA1GR-2013-00000168
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 2

Brief 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. 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

Conditions

Tooth Loss; Bone Atrophy

Keywords

regenerative medicine; bone substitutes; sinus floor augmentation

Outcome Measures

Primary Outcomes (1)

• 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.

  week +48

Secondary Outcomes (8)

• Implant survival

  week +48

• Type and incidence of surgical and post-surgical complications

  week +48

• Level of post-operative pain

  week +2

• type and dosage of post-surgery medications

  week +2

• Costs arised from the realization of the surgical procedure and during the postoperative period

  week +48

Study Arms (2)

Sinus floor augmentation (lateral)

ACTIVE COMPARATOR

Maxillary sinus floor elevation using a lateral approach

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)

Procedure: Sinus floor augmentation (transcrestal)

Interventions

Sinus floor augmentation (lateral) PROCEDURE

Sinus floor augmentation (lateral)

Sinus floor augmentation (transcrestal) PROCEDURE

Sinus floor augmentation (transcrestal)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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;
• 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;
• failure to comply with study instructions/requirements.
• Site-specific

Sponsors & Collaborators

• University Hospital of Ferrara: lead
• University of Modena and Reggio Emilia: collaborator

Study Sites (2)

University-Hospital

Ferrara, Italy

Location

University-Hospital

Modena, Italy

Location

Related Publications (3)

• 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.

  PMID: 35013782 DERIVED

• Farina 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.

  PMID: 31240743 DERIVED

• Farina 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.

  PMID: 29992594 DERIVED

MeSH Terms

Conditions

Tooth Loss

Interventions

Sinus Floor Augmentation

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Intervention Hierarchy (Ancestors)

Oral Surgical Procedures; Surgical Procedures, Operative; Bone Transplantation; Orthopedic Procedures; Dentistry

Study Officials

• Roberto Farina, Researcher

  Research Centre for the Study of Periodontal and Peri-implant Diseases, University of Ferrara, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full-Time Researcher, Chair of Oral Implantology, University of Ferrara

Study Record Dates

• First Submitted: December 2, 2014
• First Posted: April 14, 2015
• Study Start: February 1, 2015
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: February 26, 2018

Record last verified: 2018-02

Locations

IT (2)