Use of Specifically Designed Drills for Internal Sinus Lifting

Ege University28 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Vertical Alveolar Bone Loss Sinus Lifting Implant Therapy

Interventions

Sinus lifting and implant placement with osteotomesPROCEDURE

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

Sinus lifting and implant placement with specifically designed drillsPROCEDURE

Sequential drills were used for sinus membrane elevation and implant insertion

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Ege University Faculty of Dentistry

Izmir, Bornova, Turkey (Türkiye)

Outcomes

Primary Outcomes

Mean of implant insertion quantity (ISQ) value

Calculation of ISQ value for each implant

Time frame: at surgery

Mean of torque value

Calculation of torque value for each implant

Time frame: at surgery

Secondary Outcomes

Marginal bone loss

Change in peri-implant bone level

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

Implant survival

Number of mobil or loss implants

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

Pain Score

Pain level recorded between 0 to 10 points

Time frame: at postoperative first week

Analgesic consumption

Number of analgesic taken on a daily basis

Time frame: at postoperative first week

Oral health impact profile questionnaire

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

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

Data from ClinicalTrials.gov

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