Clinical trial NCT06640127: Use of Specifically Designed Drills for Internal Sinus Lifting
Official title: A Randomized Comparative Study on Internal Sinus Lifting With Simultaneous Implant Placement Using Two Different Techniques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vertical Alveolar Bone Loss
Sinus Lifting
Implant Therapy
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Mean of implant insertion quantity (ISQ) value
timeFrame: at surgery
measure: Mean of torque value
timeFrame: at surgery
Secondary outcomes:
measure: Marginal bone loss
timeFrame: through study completion, an average of 1 year
measure: Implant survival
timeFrame: through study completion, an average of 1 year
measure: Pain Score
timeFrame: at postoperative first week
measure: Analgesic consumption
timeFrame: at postoperative first week
measure: Oral health impact profile questionnaire
timeFrame: preoperatively, at postoperative first week, and at postoperative 6 months
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege University Faculty of Dentistry
state: Bornova
Study officials:
affiliation: Ege University
name: Gözde Işık
role: PRINCIPAL_INVESTIGATOR
References: