- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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.
Przegląd badań
Status
Warunki
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Tomas Linkevicius, PhD, DDS
- Numer telefonu: +37068772840
- E-mail: tomas.linkevicius@lsmu.lt
Kopia zapasowa kontaktu do badania
- Nazwa: Marius Svedas
- E-mail: svedasm@gmail.com
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
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;
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nielosowe
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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
|
|
Eksperymentalny: 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
|
|
Eksperymentalny: 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
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Implant oseointegration
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Implant insertion depth
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
|
Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Tomas Linkevicius, PhD, DDS, Lithuanian University of Health Sciences
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- Nr. 2026/4-1735-1199
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Ramy czasowe udostępniania IPD
Kryteria dostępu do udostępniania IPD
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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