Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02415946
Other study ID # PRUA1GR-2013-00000168
Secondary ID
Status Completed
Phase N/A
First received December 2, 2014
Last updated February 22, 2018
Start date February 2015
Est. completion date January 2018

Study information

Verified date February 2018
Source University Hospital of Ferrara
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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


Recruitment information / eligibility

Status Completed
Enrollment 57
Est. completion date January 2018
Est. primary completion date January 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

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.

Exclusion Criteria:

- 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;

- 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Sinus floor augmentation (lateral)

Sinus floor augmentation (transcrestal)


Locations

Country Name City State
Italy University-Hospital Ferrara
Italy University-Hospital Modena

Sponsors (2)

Lead Sponsor Collaborator
University Hospital of Ferrara University of Modena and Reggio Emilia

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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. week +48
Secondary 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. week +48
Secondary 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"). week +2
Secondary 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). week +2
Secondary 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.
week +48
Secondary 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. week +48
Secondary 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. day 0, week +48
Secondary 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. day 0, week +48
See also
  Status Clinical Trial Phase
Recruiting NCT05498662 - An Observational Study of the T3 Pro Dental Implant System
Active, not recruiting NCT05311657 - Oral Health and Severe COPD
Completed NCT01237184 - Initial Stability of Posterior Maxillary Implants With Bicortical Fixation
Not yet recruiting NCT03521024 - Effect of Zirconia Implant Supported PEKK Crowns Versus Lithium Disilicate Crowns on Esthetics N/A
Recruiting NCT04856319 - The Effect of Pre-operative Single Dose Antibiotic Prophylaxis on the Post-operative Implant Success N/A
Active, not recruiting NCT05079542 - RCT of BLT Implants Used for Immediate vs Early Placement, Restored With Ceramic Crowns on Titanium Bonding Bases. N/A
Recruiting NCT03003819 - A Comparison of Two Socket Sealing Collagen Matrices for Extraction Socket Management N/A
Completed NCT02163395 - Performance Evaluation of FullCeram Implants in Single Tooth Gaps N/A
Completed NCT02996370 - Effect of I-Shape Incısıon Technique on Inter-Implant Papilla: A Prospective Randomized Clinical Trial N/A
Completed NCT02842385 - Soft Tissue Thickness on Submerged and Non Submerged Implants N/A
Withdrawn NCT00798031 - Case Series Evaluation of a Short Dental Implant N/A
Completed NCT04559802 - Submerged Versus Non-Submerged Healing of Implants Subjected To Contour Augmentation N/A
Completed NCT00018512 - Biological Specifications for Denture Designs Phase 2
Enrolling by invitation NCT05157009 - Immediate Implant Outcomes With and Without Bone Augmentation N/A
Active, not recruiting NCT04550689 - Comparison of Dimensional Changes After Tooth Extractions Between Xenograft and Allograft N/A
Terminated NCT03580798 - Ridge Preservation Comparing Simultaneous vs. Delayed Grafting N/A
Completed NCT05016401 - Performance and Safety of Use of the "KONTACT PERIO LEVEL" Transgingival Titanium Dental Implant
Not yet recruiting NCT05096897 - Oral Health-related Quality of Life (OHRQoL) in Patients With Inflammatory Bowel Disease (IBD)
Recruiting NCT04605445 - One vs Two Visits Root Canal Treatments in Infected Teeth N/A
Enrolling by invitation NCT04938089 - Effect of Periodontal Maintenance Therapy on Tooth Loss in Regular and Irregular Compliant Smokers and Non-Smokers: A Cohort Retrospective Analysis With a Follow-up Up to 40 Years