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NCT Number: NCT07589140

Influence of Alveolar Bone Drilling and Anatomical Position on Integration

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Dental implant placement

Procedure

After tooth extraction, dental implant is placed

dental implant

Device

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 outcomes

  1. Implant success

    Time frame: 16 weeks after implant placement

    Implant will be considered integrated if implant will meet criteria follwing criteria:

    •. The implant is in its original position.

    • There are no persistent complaints.
    • There is no peri-implant inflammation.
    • There is no implant loosening.
    • There is no peri-implant radiolucency.

Secondary outcomes

  1. Marginal bone stability after one year post-treatment

    Time frame: 1 year after delivery of final crown on an implant

    Marginal bone loss will be measured in mm on radiographic images, which will be calibrated.Marginal bone loss around the implant was assessed by measuring the distance from the implant-abutment junction to the initial point of bone contact on both the mesial and distal sides, and an average was determined for each implant.

  2. Implant insertion primary stability

    Time frame: At "Day 1" of implant placement

    Primary Implant stability was determined using resonance freaquency analyzer (RFA) in both the buccolingual and mesiodistal direction and an average value is noted down. RFA calculates value in terms of ISQ (Implant Stability Quotient) ranging from 0-100. ISQ value was measured for each implant at the baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Rokas Kuprys

CONTACT

[email protected]

Tomas Linkevicius, PhD

CONTACT

[email protected]

+37068772840

Sponsors and collaborators

Lead sponsor

Lithuanian University of Health Sciences

Other

Registry information

Official study title

Influence of Alveolar Bone Drilling and Anatomical Position on the Primary Stability, Osseointegration and Functioning of Immediately Placed Dental Implants

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 15, 2026
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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