- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07585539
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.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Tomas Linkevicius, PhD, DDS
- Telefonnummer: +37068772840
- E-mail: tomas.linkevicius@lsmu.lt
Undersøgelse Kontakt Backup
- Navn: Marius Svedas
- E-mail: svedasm@gmail.com
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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;
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
After tooth extraction, dental implant is placed
After implant placement, bone graft is applied to extraction socket
Non-resorbable membrane is put on the implant to prevent loading
|
|
Eksperimentel: 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
|
After tooth extraction, dental implant is placed
After implant placement, bone graft is applied to extraction socket
Composite healing abutment is formed chairside after implant placement and abutment is attcahed to the implant
|
|
Eksperimentel: 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.
|
After tooth extraction, dental implant is placed
After implant placement, bone graft is applied to extraction socket
Prefabricated temporary crown is attcahed to the implant after implant placement
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Implant oseointegration
Tidsramme: After 4 months post-insertion
|
Implant will be considered integrated if implant will meet criteria (Buser et al, 1990) •. The implant is in its original position.
|
After 4 months post-insertion
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Implant insertion depth
Tidsramme: After implant placement and after 4 months post-healing
|
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
Tidsramme: After delivery of implant restoration and after 1 y follow-up
|
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
Tidsramme: After prosthesis delivery and after 1 year
|
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:
|
After prosthesis delivery and after 1 year
|
|
Implant stability quotient (ISQ) value
Tidsramme: After implant insertion and after osseointegration
|
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)
Tidsramme: After prosthesis delivery and after 1 year
|
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
Tidsramme: After prosthesis delivery and after 1 year
|
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)
Tidsramme: After prosthesis delivery and after 1 year
|
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)
Tidsramme: After prosthesis delivery and after 1 year
|
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
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Tomas Linkevicius, PhD, DDS, Lithuanian University of Health Sciences
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- Nr. 2026/4-1735-1199
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
IPD-delingsadgangskriterier
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Øjeblikkelig indlæsning af tandimplantater
-
Universidad Complutense de MadridAfsluttetDental Implant-Abutment DesignSpanien
-
Università degli Studi di SassariDr. Dario Melodia; Dr. Milena Pisano; Prof. Silvio Mario Meloni; Prof. Edoardo... og andre samarbejdspartnereIkke rekrutterer endnu
-
Università degli Studi di SassariDr. Dario Melodia; Dr. Milena Pisano; Dr. Aurea Lumbau; Prof. Silvio Mario... og andre samarbejdspartnereIkke rekrutterer endnu
-
Semmelweis UniversityInstitut Straumann AGRekrutteringDental Implant-Abutment Design | Tandimplantater, enkelttandUngarn
-
Università degli Studi di SassariDr. Dario Melodia; Dr. Milena Pisano; Prof. Silvio Mario Meloni; Prof. Edoardo... og andre samarbejdspartnereIkke rekrutterer endnuTandimplantat | Dental Implant-Abutment DesignItalien
-
Università degli Studi di SassariDr. Dario Melodia; Dr. Milena Pisano; Dr. Aurea Lumbau; Prof. Silvio Mario... og andre samarbejdspartnereIkke rekrutterer endnuTandimplantat | Dental Implant-Abutment Design | Edentuous kæbe
-
Kıvanç AkçaHacettepe UniversityAfsluttetCementering (MeSH Unikt ID: D002484) | Dental Implant-Abutment Design (MeSH Unikt ID: D059605) | Krone (MeSH Unikt ID: D003442) overflader | Kontur: Krone (MeSH Unique ID: D003442) - Tandimplantat (MeSH Unique ID: D015921) AbutmentKalkun
Kliniske forsøg med Implant placement
-
Stanford UniversityTauTona GroupAktiv, ikke rekrutterende
-
Ideal Implant IncorporatedAfsluttetBrystimplantaterForenede Stater
-
Evasc Medical Systems Corp.Radboud University Medical CenterAfsluttetIntrakraniel aneurisme | Sackulær aneurismeHolland, Danmark, Tyskland
-
Outcome Referrals, Inc.National Institutes of Health (NIH); Children's Hope AllianceTilmelding efter invitationMental Health Wellness | Teenagers TrivselForenede Stater
-
Apreo Health, Inc.AfsluttetEmfysem eller KOLAustralien
-
Envoy Medical CorporationAktiv, ikke rekrutterendeSensorineuralt høretab | Sensorineuralt høretab (lidelse) | Sensorineuralt høretab, bilateralt | Sensorineuralt høretab, alvorligt | Sensorineuralt høretab, dybt | Sensorisk-neural døvhedForenede Stater
-
Medical University of GrazAfsluttet
-
Apreo Health, Inc.Aktiv, ikke rekrutterendeEmfysem eller KOLDet Forenede Kongerige, Holland, Østrig
-
Med-El CorporationAfsluttet
-
Institut Straumann AGAfsluttet