Influence of Alveolar Bone Drilling and Anatomical Position on Integration
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: dental implant placement, Dental implant.
- Who it may be relevant to
- Registry conditions: Dental Implant, Bone Grafting, Immediate Dental Implant Placement. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Lithuania
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Influence of Alveolar Bone Drilling and Anatomical Position on the Primary Stability, Osseointegration and Functioning of Immediately Placed Dental Implants
Overview
The goal of this clinical trial is to learn if alveolar bone drilling and anatomical position of an immediately placed dental implant has influence on the primary stability, osseointegration and function. It aims to answer these questions: * Does absence of alveolar drilling before implant placement give the same result as traditional osteotomy with apical drilling? * Is palatinal root position of implant as succesful as central position? Researchers will compare crestal bone levels and primary stability of the implant after insertion in the groups. Subjects will be assigned to groups, acoording to clinical situation. Study groups: 1. Dental implants will be placed in the extraction socket with an apical osteotomy. 2. Dental implants will be placed in the extraction socket without performing an osteotomy. 3. Dental implants will be placed in the centre of the extracted maxillary molar socket. 4. Dental implants will be placed into the palatal root socket of the extracted maxillary molar.
Detailed description
Tooth extraction and subsequent implantation will be performed under local anesthesia. After tooth extraction, an osteotomy is performed in the tooth socket to create a bed for the implant. The patients will be divided into groups based on the bone condition after tooth extraction. Participants in this study were scheduled for tooth extraction followed by immediate implant placement. One hour prior to the procedure, patients were administered 1 g of amoxicillin orally, which was continued at a dosage of twice daily for one week after the procedure. Teeth were extracted under local anesthesia using 4% articain with epi-nephrine 1:100000 (Ubistesin forte, 3M ESPE, USA), with an emphasis on minimizing trauma and avoiding flap elevation, employing root sectioning if necessary. Care was taken to preserve the marginal gingiva and papillae. Following extraction, the socket was cleaned and assessed. Osteotomies were created using the original drills in a sequence specified by the implant manufacturer. The implant was placed centrally in the me-sio-distal aspect and more towards the lingual/palatal side of the socket. The insertion torque was recorded with manual torque wrench. Anatomical or individual healing abutments were used after implant placement. Individual healing abutments were crafted chairside using original titanium temporary abutments and flowable composite, creating critical and subcritical contours. The composite was polished meticulously. All healing abutments were secured on the implants with 15 Ncm torque. Postoperative instructions were provided both verbally and, in a booklet, advising patients to rinse their mouths twice daily for 2 weeks with a commercially available mouth rinse containing 0.12% chlorhexidine di-gluconate.
After 4 months, the osseointegration of implants was evaluated for presence or absence of following symptoms: pain, recurrent peri-implant infections, mobility on manual palpation and continuous peri-implant radiolucency. If those symptoms were absent, implant was deemed successfully integrated and implant schedulled for restoration. During prosthetic visit, open tray transfer was connected to the implant and open tray silicone impressions for final restorations were taken. Healing abutment put back to the implant. In the lab a screw-retained full-contour zirconia crowns with ultra-polished subgingival areas, using the polishing protocol were fabricated. At the delivery date, zirconia crown retained to the implant with fingers and torqued to 35N/cm using implant wrentch. The access holes were filled with Teflon tape, and while the top 1 mm was sealed with flowable composite . Individual oral hygiene instructions were provided both verbally and in booklet form. Scheduling of follow-up visits were carried out after 1 year of last dental visit.
Interventions
- Procedure dental implant placement
After tooth extraction, dental implant is placed - Device Dental implant
Small sterile titanium screw-type with rough surface placed it into the jawbone - just underneath the gum. The titanium implant will fuse over the bone (also known as osseointegration), forming an anchor for a replacement tooth.
Primary outcome measures
- Implant success [Time frame: 16 weeks after implant placement]
Secondary outcome measures (2)
- Marginal bone stability after one year post-treatment [Time frame: 1 year after delivery of final crown on an implant]
- Implant insertion primary stability [Time frame: At "Day 1" of implant placement]
Eligibility criteria
Inclusion criteria
- ≥ 18 years old.
- healthy patients without medical contraindications for dental implantation surgery.
- removable and non-molar teeth indicated for extraction in both jaws
- healthy soft tissues (bleeding on probing < 20%, plaque index < 25%);
- intact alveolar bone walls post-extraction
- signed informed consent form and permission to use the obtained data for research purposes.
Exclusion criteria
- Smokers (≥ 10 cigarettes per day);
- history of uncontrolled periodontitis;
- uncontrolled diabetes/alcoholism;
- use of drugs that may affect healing;
- persons who, due to health status, cannot be considered capable of reasonably assessing their interests;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Lithuania · 1 center
- UAB "Panevėžio burnos chirurgijos centras" — Panevezys
Identifiers
NCT: NCT07589140 · Nr. 2026/4-1756-1203