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NCT Number: NCT06123221

SINUS FLOOR WITH OSSEODENSIFICATION OR LATERAL WINDOW

This study will compare patient-reported outcomes, as well as the type and incidence of complications, and bone marginal loss after 12 months in implants installed using the transcrestal approach (tSFE) with an osseodensification system (performed according to the protocol by Huwais et al. 2018), or installed simultaneously using the lateral window technique (lSFE) with sinus lift. A blind, randomized, controlled clinical trial will be carried out with individuals over 18 years old, and with single tooth loss in the posterior maxilla, where the residual bone height (RBH) is 3 to 5 mm. The tSFE will be performed with osseodensification burs (Densa Bur, Versah, USA) using a counterclockwise motion, associated to synthetic biomaterial (hydroxyapatite and beta-tricalcium phosphate). The lSFE technique will require the sinus to be filled with the same biomaterial as the group using the other technique, and the antrostomy to be covered with a polydioxanone-based membrane. The patient's post-operatory perceptions will be evaluated by self-administered questionnaires quantifying social and professional isolation, physical appearance, duration and changes in quality of life, eating and speech, diet variations, and sleep deficiency for 2 weeks after the procedure. Pain will be assessed with the visual analogue scale (VAS). Immediately after prosthetic rehabilitation, cone beam tomography will be performed. Controls at 6 and 12 months will be performed. In these images, the marginal bone level in relation to a fixed reference point on the implants (upper part of the platform) will be measured mesially and distally in each implant, using a specific program (ImageJ - version 1.49v / NIH software - Bethesda, MD, USA). Generalized estimating equations will be used to compare the two treatments overtime. The significance level used will be 0.05.

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Key information

Conditions

Sinus Tract Dental Implant Failed

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alex Haas

Porto Alegre, Rio Grande do Sul, 90630080, Brazil

Location status: Recruiting

Location contact

Alex N Haas

CONTACT

[email protected]

555191222377

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Maxillary sinuses that have residual bone height between at least 3 mm and 5 mm;
  • Width of the residual bone ridge that allows the insertion of an implant with a diameter of 4 mm;
  • Tomographic thickness of Schneider's membrane with a maximum of 5 mm in the region to be operated;
  • Residual ridge with ≥2 mm of medullary bone in the bucco-palatal direction, with a 1/1 ratio of medullary and cortical bone to achieve predictable plastic expansion;
  • Patients with adequate interarch space for placement of the prosthetic crown;
  • Good physical health status (ASA1 and ASA2, according to the Physical Status Classification System - American Society of Anesthesiologists);
  • At least 6 months since the last tooth loss in the region to be operated;

Exclusion criteria

  • - Those with sinus pathology;
  • Heavy smokers (more than 10 cigarettes a day);
  • Those with a history of head and neck radiotherapy;
  • Those who have already undergone bone augmentation in any of the targeted surgical areas;
  • Immunodeficiency of any nature;
  • Emotional instability and psychiatric problems;
  • Pregnancy;
  • Current use of oral bisphosphonates or history of using injectable bisphosphonate;
  • Patients with active periodontitis defined by the presence of subgingival bleeding greater than 10%;
  • Documented allergy to drugs or dental materials involved in the experimental protocol.

Treatment and study plan

Osseodensification with Versah system

Procedure

Access to the bone crest will be performed through a slightly palatinized crestal incision, and a full-thickness mucoperiosteal flap will be elevated. Implant site preparation will be performed according to the bone densification drilling sequence established by the Densah® technique protocol

Lateral window

Procedure

A full-thickness mucoperiosteal flap will be elevated. The lateral window will be made with a spherical diamond drill (number 8) at 20,000 rpm. The mesiodistal and apicocoronal dimensions of the lateral access window to the sinus will be measured in all the participants using a caliper. Sinus membrane elevation will be performed with manual instruments.

Primary outcomes

  1. Pain level

    Time frame: baseline

    visual analogue scale (VAS), ranging from "0 - no pain" to "100 - worst imaginable pain"

  2. Pain level

    Time frame: day 1

    visual analogue scale (VAS), ranging from "0 - no pain" to "100 - worst

  3. Pain level

    Time frame: day 2

    visual analogue scale (VAS), ranging from "0 - no pain" to "100 - worst

  4. Pain level

    Time frame: day 3

    visual analogue scale (VAS), ranging from "0 - no pain" to "100 - worst

  5. Pain level

    Time frame: day 4

    visual analogue scale (VAS), ranging from "0 - no pain" to "100 - worst

  6. Pain level

    Time frame: day 7

    visual analogue scale (VAS), ranging from "0 - no pain" to "100 - worst

  7. Pain level

    Time frame: day 14

    visual analogue scale (VAS), ranging from "0 - no pain" to "100 - worst

Secondary outcomes

  1. Medication Diary (number of doses of Ibuprofen 600mg)

    Time frame: baseline

    Rescue anti-inflammatory drug dosage (i.e. number of ibuprofen 600 mg tablets), and name of other types of drugs taken as of the day of surgery up to the 14th postoperative day, recorded daily in a medication diary

  2. Medication Diary (number of doses of Ibuprofen 600mg)

    Time frame: day 1

    Rescue anti-inflammatory drug dosage (i.e. number of ibuprofen 600 mg tablets), and name of other types of drugs taken as of the day of surgery up to the 14th postoperative day, recorded daily in a medication diary

  3. Medication Diary (number of doses of Ibuprofen 600mg)

    Time frame: day 2

    Rescue anti-inflammatory drug dosage (i.e. number of ibuprofen 600 mg tablets), and name of other types of drugs taken as of the day of surgery up to the 14th postoperative day, recorded daily in a medication diary

  4. Medication Diary (number of doses of Ibuprofen 600mg)

    Time frame: day 3

    Rescue anti-inflammatory drug dosage (i.e. number of ibuprofen 600 mg tablets), and name of other types of drugs taken as of the day of surgery up to the 14th postoperative day, recorded daily in a medication diary

  5. Medication Diary (number of doses of Ibuprofen 600mg)

    Time frame: day 4

    Rescue anti-inflammatory drug dosage (i.e. number of ibuprofen 600 mg tablets), and name of other types of drugs taken as of the day of surgery up to the 14th postoperative day, recorded daily in a medication diary

  6. Medication Diary (number of doses of Ibuprofen 600mg)

    Time frame: day 5

    Rescue anti-inflammatory drug dosage (i.e. number of ibuprofen 600 mg tablets), and name of other types of drugs taken as of the day of surgery up to the 14th postoperative day, recorded daily in a medication diary

  7. Medication Diary (number of doses of Ibuprofen 600mg)

    Time frame: day 6

    Rescue anti-inflammatory drug dosage (i.e. number of ibuprofen 600 mg tablets), and name of other types of drugs taken as of the day of surgery up to the 14th postoperative day, recorded daily in a medication diary

  8. Medication Diary (number of doses of Ibuprofen 600mg)

    Time frame: day 7

    Rescue anti-inflammatory drug dosage (i.e. number of ibuprofen 600 mg tablets), and name of other types of drugs taken as of the day of surgery up to the 14th postoperative day, recorded daily in a medication diary

  9. Medication Diary (number of doses of Ibuprofen 600mg)

    Time frame: day 8

    Rescue anti-inflammatory drug dosage (i.e. number of ibuprofen 600 mg tablets), and name of other types of drugs taken as of the day of surgery up to the 14th postoperative day, recorded daily in a medication diary

  10. Medication Diary (number of doses of Ibuprofen 600mg)

    Time frame: day 9

    Rescue anti-inflammatory drug dosage (i.e. number of ibuprofen 600 mg tablets), and name of other types of drugs taken as of the day of surgery up to the 14th postoperative day, recorded daily in a medication diary

  11. Medication Diary (number of doses of Ibuprofen 600mg)

    Time frame: day 10

    Rescue anti-inflammatory drug dosage (i.e. number of ibuprofen 600 mg tablets), and name of other types of drugs taken as of the day of surgery up to the 14th postoperative day, recorded daily in a medication diary

  12. Medication Diary (number of doses of Ibuprofen 600mg)

    Time frame: day 11

    Rescue anti-inflammatory drug dosage (i.e. number of ibuprofen 600 mg tablets), and name of other types of drugs taken as of the day of surgery up to the 14th postoperative day, recorded daily in a medication diary

  13. Medication Diary (number of doses of Ibuprofen 600mg)

    Time frame: day 12

    Rescue anti-inflammatory drug dosage (i.e. number of ibuprofen 600 mg tablets), and name of other types of drugs taken as of the day of surgery up to the 14th postoperative day, recorded daily in a medication diary

  14. Medication Diary (number of doses of Ibuprofen 600mg)

    Time frame: day 13

    Rescue anti-inflammatory drug dosage (i.e. number of ibuprofen 600 mg tablets), and name of other types of drugs taken as of the day of surgery up to the 14th postoperative day, recorded daily in a medication diary

  15. Medication Diary (number of doses of Ibuprofen 600mg)

    Time frame: day 14

    Rescue anti-inflammatory drug dosage (i.e. number of ibuprofen 600 mg tablets), and name of other types of drugs taken as of the day of surgery up to the 14th postoperative day, recorded daily in a medication diary

Other outcomes

  1. Level of discomfort

    Time frame: as recorded on day 0 (night), +1, +2, +3, +4, +7, and +14,

    Level of discomfort as recorded on a 5-point rating scale ranging from "no discomfort"; "little discomfort"; "discomfort"; "a lot of discomfort" and "very high discomfort"

  2. Limitations in daily functions

    Time frame: as recorded on day 0 (night), +1, +2, +3, +4, +7 and + 14

    Limitations in daily functions (i.e. swallowing, breathing, continuing daily activities, eating, speaking, opening the mouth), on a 5-point rating scale ranging from "no limitations" to "unable to eat all kinds of food" (for the item "eat"), and from "no difficulty" to "extreme difficulty" (for the other items );

  3. Incidence of postoperative signs and symptoms

    Time frame: day 0 (night), +1, +2, +3, +4, +7 and +14;

    Incidence of swelling, nausea, bruising, nasal discharge/bleeding, nasal stuffiness, bad taste/smell

  4. Willingness to undergo the same type of surgery

    Time frame: recorded on day +14

    a 4-point rating scale ranging from "no problem to repeat surgery if needed" to "I will never have this type of surgery again."

  5. Clinical Outcomes

    Time frame: 7 and 14 days after surgery

    Membrane perforation (yes or no) will be evaluated during the transoperative period. In addition, the following clinical outcomes will be evaluated: Face edema (yes or no);

    • Facial hematoma (yes or no);
    • Presence of suppuration;
    • Suture dehiscence.

  6. Cinical evaluation of Implant failure

    Time frame: through study completion, an average of 18 months

    Implant loss may occur during the phase of osseointegration (early) or at a later time when the previously achieved osseointegration is lost (late). Implant loss defined by lack of osseointegration represented by mobility, and will be assessed at throughout the entire search

  7. Peri-implant clinical examinations

    Time frame: 1 and 12 months after the installation of the prosthesis

    probing depth in millimeters will be evaluated at six sites per implant (mesiobuccal, buccal, distobuccal, and mesiolingual/palatal, lingual/palatal, distolingual/palatal).

  8. Peri-implant clinical examinations

    Time frame: 1 and 12 months after the installation of the prosthesis

    submucosal bleeding points after probing will be evaluated at six sites per implant (mesiobuccal, buccal, distobuccal, and mesiolingual/palatal, lingual/palatal, distolingual/palatal).

  9. Tomographic outcomes

    Time frame: 1 and 12 months after the installation of the prosthesis

    The images will be used to measure the marginal bone level mesially and distally in each implant, in relation to a fixed reference point on the implants (upper part of the platform), using a specific program (ImageJ)

Sponsors and collaborators

Lead sponsor

Federal University of Rio Grande do Sul

Other

Registry information

Official study title

COMPARISON OF IMPLANT INSTALLATION USING THE TRANSCRESTAL APPROACH WITH OSSEODENSIFICATION OR THE LATERAL WINDOW TECHNIQUE WITH SINUS LIFT: A RANDOMIZED CONTROLLED TRIAL.

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Nov 8, 2023
Registry last updated
Nov 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.

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