Dental Implantation, Peri-Implant Marginal Bone Loss
Conditions
Keywords
Ozone, Dental Implant, Cone-Beam Computed Tomography, Alveolar Bone Loss
Brief summary
This study examined whether adding local gaseous ozone to standard dental implant treatment could reduce early bone loss around implants. Fifty adults requiring matched implants on opposite sides of the same jaw participated. Within each participant, matched implant sites were randomly assigned to ozone treatment or standard treatment without ozone. Ozone was applied to the prepared implant socket during surgery and to the peri-implant surgical site after suturing and on postoperative days 1, 3, 5, and 7. Changes in marginal bone levels from baseline to 6 months were assessed using cone-beam computed tomography (CBCT).
Detailed description
This prospective, split-mouth randomized clinical trial was conducted at the Department of Periodontology, Faculty of Dentistry, Adıyaman University. Participants required implant placement at matched contralateral posterior sites within the same jaw. Within each participant, matched implant sites were randomly allocated to adjunctive local gaseous ozone treatment or standard treatment without ozone. Ozone was applied to the prepared implant socket during surgery and to the peri-implant surgical site after suturing and on postoperative days 1, 3, 5, and 7. Fifty participants were enrolled; two were lost to follow-up, and 48 participants with 152 implants completed the study. The final analysis included 76 ozone-treated and 76 control implants. The primary outcome was the change in peri-implant marginal bone level from baseline to 6 months, assessed using cone-beam computed tomography at the buccal, palatal/lingual, mesial, and distal implant surfaces. The outcome assessor was blinded to treatment allocation.
Interventions
PROCEDUREGaseous Ozone Application
Gaseous ozone was applied to the surgically prepared implant socket before implant placement. Following suturing, ozone was applied locally to the peri-implant surgical site and was repeated on postoperative days 1, 3, 5, and 7.
PROCEDUREConventional Implant Placement
Implants were placed using the standard surgical protocol, followed by standard postoperative care, without intraoperative or postoperative ozone application.
Sponsors
Adiyaman University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The radiographic outcome assessor was blinded to treatment allocation. The operating surgeon was not blinded because of the nature of the intervention.
Intervention model description
This prospective split-mouth randomized clinical trial used within-participant, site-level allocation. Each participant received both interventions concurrently: matched contralateral implant sites within the same jaw were randomly allocated to adjunctive local gaseous ozone treatment or standard treatment without ozone. Thus, each participant served as their own control.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Adults aged 18 to 65 years. * Systemically healthy individuals. * Ability to comply with the study procedures and follow-up visits. * Requirement for implant placement at matched contralateral posterior sites within the same jaw. * Healed edentulous sites suitable for conventional implant placement. * Adequate alveolar bone volume for placement of implants measuring 3.5-4.0 mm in diameter and 8-12 mm in length without the need for advanced bone augmentation, with at least 1.5 mm of surrounding bone. * Initial soft-tissue thickness of at least 2 mm and keratinized mucosal width of at least 2 mm at the implant sites. * Provision of written informed consent.
Exclusion criteria
* Systemic diseases or medical conditions contraindicating implant surgery. * Pregnancy. * Smoking. * Active oral infection or advanced periodontal disease. * Insufficient bone volume requiring advanced bone augmentation. * Incomplete healing at the intended implant site following recent tooth extraction. * Previous implant failure at the intended implant site. * Any contraindication to ozone therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Marginal Bone Level Around Dental Implants | Baseline and 6 months after implant placement | Using cone-beam computed tomography (CBCT), the vertical distance from the implant shoulder to the first bone-to-implant contact was measured in millimeters at the buccal, palatal/lingual, mesial, and distal surfaces at baseline and 6 months. For each surface, marginal bone level change was calculated as the 6-month distance minus the baseline distance; positive values indicated greater marginal bone loss. Combined buccolingual and mesiodistal measurements were calculated by averaging the corresponding surface measurements. Changes were compared between matched ozone-treated and control implant sites. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORMETİN ÇALIŞIR, PhD
Department of Periodontology, Faculty of Dentistry, Adıyaman University, Adıyaman, Turkey
Outcome results
None listed