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Completed

NCT Number: NCT06640127

Use of Specifically Designed Drills for Internal Sinus Lifting

This study was conducted at Ege University, School of Dentistry, Izmir, Turkey. Patients enrolled require implant placement to the atrophic posterior maxilla. Patients were treated with either the specifically designed drills or the osteotomes. The outcome variables were primary stability, marginal bone loss, implant survival, and patient-reported outcomes. The investigators aimed to compare the treatment outcomes of two different techniques used in dental implant placement with internal sinus lifting.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ege University Faculty of Dentistry

Izmir, Bornova, 35100, Turkey (Türkiye)

About this study

This prospective, randomized clinical study was conducted at the Ege University School of Dentistry and Department of Oral and Maxillofacial Surgery. Patients with atrophic maxillas and at least one tooth loss in this region were included. Randomization was performed to assign the patients to study groups. Patients treated with internal sinus lift using osteotome and implant surgery were assigned to Group 1, and patients treated with internal sinus lift using specifically designed drills and implant surgery were assigned to Group 2. At six months postoperatively, the healing cap was inserted during the second stage of surgery.

All implants were assessed based on primary stability (using implant stability quotient and torque value), marginal bone loss (as millimeters), and implant survival (as a percentage). Also, patient-reported outcomes were collected, including pain (using a visual analog scale), analgesic consumption (number of drugs taken during a week), and oral health impact profile survey).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Unilaterally or bilaterally missing teeth in the posterior maxilla,
  • Residual bone height (4 mm to 6 mm),
  • Completed periodontal and oral hygiene treatment,
  • American Society of Anesthesiologists (ASA) score of I or II,
  • > 18 years old,
  • Willingness to participate

Exclusion criteria

  • Infection or pathology related to maxillary sinus and surgical site,
  • Tooth extraction within six months in the surgical site,
  • Previous maxillary sinus surgery,
  • Parafunction,
  • Medical conditions associated with impaired or delayed wound healing,
  • Smoking habit and alcohol or drug abuse,
  • Pregnancy or nursing

Treatment and study plan

Sinus lifting and implant placement with osteotomes

Procedure

Osteotomes with increasing diameters were used for sinus membrane elevation and implant insertion

Sinus lifting and implant placement with specifically designed drills

Procedure

Sequential drills were used for sinus membrane elevation and implant insertion

Primary outcomes

  1. Mean of implant insertion quantity (ISQ) value

    Time frame: at surgery

    Calculation of ISQ value for each implant

  2. Mean of torque value

    Time frame: at surgery

    Calculation of torque value for each implant

Secondary outcomes

  1. Marginal bone loss

    Time frame: through study completion, an average of 1 year

    Change in peri-implant bone level

  2. Implant survival

    Time frame: through study completion, an average of 1 year

    Number of mobil or loss implants

  3. Pain Score

    Time frame: at postoperative first week

    Pain level recorded between 0 to 10 points

  4. Analgesic consumption

    Time frame: at postoperative first week

    Number of analgesic taken on a daily basis

  5. Oral health impact profile questionnaire

    Time frame: preoperatively, at postoperative first week, and at postoperative 6 months

    Total score of self-administered questionnaire assessed using Likert-point scale between 0 to 4

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Official study title

A Randomized Comparative Study on Internal Sinus Lifting With Simultaneous Implant Placement Using Two Different Techniques

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Oct 15, 2024
Registry last updated
Oct 15, 2024

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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