Implant Therapy, Sinus Lifting, Vertical Alveolar Bone Loss
Conditions
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).
Interventions
PROCEDURESinus lifting and implant placement with osteotomes
Osteotomes with increasing diameters were used for sinus membrane elevation and implant insertion
PROCEDURESinus lifting and implant placement with specifically designed drills
Sequential drills were used for sinus membrane elevation and implant insertion
Sponsors
Ege University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean of implant insertion quantity (ISQ) value | at surgery | Calculation of ISQ value for each implant |
| Mean of torque value | at surgery | Calculation of torque value for each implant |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score | at postoperative first week | Pain level recorded between 0 to 10 points |
| Marginal bone loss | through study completion, an average of 1 year | Change in peri-implant bone level |
| Oral health impact profile questionnaire | 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 |
| Analgesic consumption | at postoperative first week | Number of analgesic taken on a daily basis |
| Implant survival | through study completion, an average of 1 year | Number of mobil or loss implants |
Countries
Turkey (Türkiye)
Outcome results
None listed