Influence of the Primary Stability and Temporary Prosthetics

Influence of the Primary Stability and Temporary Prosthetics of a Placed Dental Implant on Implant Osseointegration and Further Function When Performing Immediate Implantation in the Posterior Tooth Regions.

The goal of this clinical trial is to to determine how different primary implant stability and loading management affect implant osseointegration and further function after one year. The main questions it aims to answer are: is primary stability of inserted implant needed for implant integration? Does primary stability and restoration mode of the implant influence marginal bone stability of that implant? Researchers will compare crestal bone levels and primary stability of the implant after insertion in 3 groups. Subjects will be assigned to groups, acoording to primary stability developed during insertion of the implant. Study groups - (1) If stability is low (5-10 N/cm), Megagen BlueDiamond implants will be inserted, and a temporary prosthesis will not be placed; the implant will be sutured; (2) If stability is moderate (15-35 N/cm), Megagen BlueDiamond implants will be inserted, and a custom plastic gingiva-forming healing abutment will be placed; (3) If stability is high (40 N/cm and higher), Megagen BlueDiamond implants will be inserted, and a temporary plastic crown will be placed. Primary outcome of the study will be implant integration, secondary ourtcomes - implant insertion depth during insertion and after osseointegration, marginal bone stability after prosthesis delivery and after one year, determination of the PES (pink esthetic score) index after prosthesis delivery and after 1 year, determination of the ISQ value after implant insertion and after osseointegration, changes in gingival volume around the implants after 1 year, determination of the Plaque Index (PI) after prosthesis delivery and after 1 year, determination of the Probing Pocket Depth (PPD) after prosthesis delivery and after 1 year, determination of the Bleeding on Probing (BOP) index after prosthesis delivery and after 1 year.

Study Overview

• Status: Not yet recruiting
• Conditions: Immediate Dental Implant Loading; Marginal Bone Levels; Immediate Dental Implant Placement
• Intervention / Treatment: Procedure: Implant placement; Procedure: Bone grafting of the implant; Procedure: Non-resorbable membrane; Procedure: Healing abutment; Procedure: Temporary crown

Detailed Description

In Group 1 and Group 2 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 (3M Supreme Filtek Flow, 3M ESPE, USA), creating critical and subcritical contours. The composite was polished meticulously. All immediate implant sites were grafted with allogenic cortical/cancellous particulate (1000-1700 micron) bone and 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 ab-sence 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 silicone impressions for final restorations were taken. Screw-retained full-contour zirconia crowns with ultra-polished subgingival areas, using the protocol described by Linkevicius et al. 2017 were delivered. The access holes were filled with Teflon tape, and while the top 1 mm was sealed with flowable composite (Figure 3D). 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.

In Group 3 Following the extraction of molars under local anaesthesia, socket was debrided using surgical curette until hard bone surface was felt. Following copious irrigation with saline, an ultrawide diameter implant(8.0mm X8.0mm; Megagen Anyridge) was placed in the depth of the socket with zero insertion torque (T1). Socket was then allowed to fill with fresh blood. The remaining part of the socket present coronal to implant platform (measuring 6mm approx.) was then sealed with xenograft particles in a similar manner to alveolar ridge preservation. This was carried out in order to prevent the resorption of buccolingual width while simultaneously utilizing the benefits of immediate implant placement. In order to separate the xenograft particles from the oral microenvironment, a non-resorbable d-PTFE membrane was placed with its edges inserted into buccal and lingual flaps. This was further secured using criss cross sutures(5-0 Polyglycolic acid) along the occlusal surface. Suture removal was done 10 days post operatively and the site was allowed to heal for 04 months. d-PTFE membrane was then removed which revealed completely epithelialized with xenograft particles integrated over the implant platform which was confirmed on the radiograph.

Stage II implant exposure surgery was performed after 04 months of implant placement. Implant was deemed successful if there was no implant mobility and apparently healthy mucosa around implant.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tomas Linkevicius, PhD, DDS; Phone Number: +37068772840; Email: tomas.linkevicius@lsmu.lt
• Study Contact Backup: Name: Marius Svedas; Email: svedasm@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 5-10 N/cm; Stability is low (5-10 N/cm), Megagen BlueDiamond implants will be inserted, and a temporary prosthesis will not be placed; the implant will be sutured.	Procedure: Implant placement; After tooth extraction, dental implant is placed; Procedure: Bone grafting of the implant; After implant placement, bone graft is applied to extraction socket; Procedure: Non-resorbable membrane; Non-resorbable membrane is put on the implant to prevent loading
Experimental: 15-35 N/cm; Stability is moderate (15-35 N/cm), Megagen BlueDiamond implants will be inserted, and a custom plastic gingiva-forming healing abutment will be placed	Procedure: Implant placement; After tooth extraction, dental implant is placed; Procedure: Bone grafting of the implant; After implant placement, bone graft is applied to extraction socket; Procedure: Healing abutment; Composite healing abutment is formed chairside after implant placement and abutment is attcahed to the implant
Experimental: 40 N/cm and more; Stability is high (40 N/cm and higher), Megagen BlueDiamond implants will be inserted, and a temporary plastic crown will be placed.	Procedure: Implant placement; After tooth extraction, dental implant is placed; Procedure: Bone grafting of the implant; After implant placement, bone graft is applied to extraction socket; Procedure: Temporary crown; Prefabricated temporary crown is attcahed to the implant after implant placement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant oseointegration	Implant will be considered integrated if implant will meet criteria (Buser et al, 1990) •. 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.	After 4 months post-insertion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant insertion depth	Implant insertion depth from free gingival margin till the neck of the implant will be measured in mm with 0.5 mm graded periodontal probe after implant insertion and 4 months after implant osseointegrartion	After implant placement and after 4 months post-healing
Marginal bone loss	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.	After delivery of implant restoration and after 1 y follow-up
PES (pink esthetic score) index	The gingival response to a anterior esthetic evaluation is assessed by the Pink Esthetic Score (PES) from clinically according to seven variables scored from 0→2: Mesial papilla; Distal papilla,; Keratinized gingiva,; Curvature of the gingival margin,; Level of the gingival margin,; Root convexity; Scar formation. The bigger ther score - better. Maximum points - 14	After prosthesis delivery and after 1 year
Implant stability quotient (ISQ) value	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 followed by just before the final restoration.	After implant insertion and after osseointegration
Plaque Index (PI)	Plaque index is calucated visually by scoring from 0-3. 0 = no plaque. 1 = separate flecks of plaque at the cervical margin of the tooth. 2 = a thin continuous band of plaque (up to 1 mm) at the cervical margin of the tooth. 3 = a band of plaque wider than 1 mm but covering less than one-third of the crown of the tooth.	After prosthesis delivery and after 1 year
Gingival volume around the implants	Gingival volume around the implants will measured in mm3 from intraoral scans of implant-supported restoration.	After prosthesis delivery and after 1 year
Probing Pocket Depth (PPD)	PPD will measured in mm with periodontal probe. Periodontal probing depth (PPD) is measured from the gingival margin to the base/bottom (coronal portion of the junctional epithelium (JE) of the periodontal pocket to the nearest mm. 4 points around each implant prosthesis will be measured - mesiobucal, distobucal, mesiolingual/palatinal and distolingual/palatinal. The mean number of 4 measurements will be presented	After prosthesis delivery and after 1 year
Bleeding on Probing (BOP)	Bleeding on probing is registered during pocket probing. Sites are characterized by the absence of BOP as well as the absence of GI bleeding (scores 0 and 1)	After prosthesis delivery and after 1 year

Collaborators and Investigators

• Sponsor: Tomas Linkevicius
• Collaborators: Lithuanian University of Health Sciences
• Investigators: Principal Investigator: Tomas Linkevicius, PhD, DDS, Lithuanian University of Health Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): May 7, 2026
• Primary Completion (Estimated): October 16, 2027
• Study Completion (Estimated): January 5, 2028

Study Registration Dates

• First Submitted: May 4, 2026
• First Submitted That Met QC Criteria: May 9, 2026
• First Posted (Actual): May 13, 2026

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 9, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Dental implant
• Other Study ID Numbers: Nr. 2026/4-1735-1199

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all IPD that underlie results in a publication
• IPD Sharing Time Frame: July 2026-July 2027
• IPD Sharing Access Criteria: Qualified researchers at accredited institutions (academia, government, non-profit, industry with legitimate scientific intent) will be eligable for sharing. Access will be granted upon resonable request via secure controlled environment (virtual data enclave, Secure Research Environment) or encrypted transfer to approved secure servers. Datasets will be de-identified consistent with prevailing standards.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No