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Influence of the Primary Stability and Temporary Prosthetics

9 maja 2026 zaktualizowane przez: Tomas Linkevicius

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.

Przegląd badań

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

Interwencyjne

Zapisy (Szacowany)

90

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

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

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

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.

  • 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

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:

  1. Mesial papilla
  2. Distal papilla,
  3. Keratinized gingiva,
  4. Curvature of the gingival margin,
  5. Level of the gingival margin,
  6. Root convexity
  7. Scar formation. The bigger ther score - better. Maximum points - 14
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

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Śledczy

  • Główny śledczy: Tomas Linkevicius, PhD, DDS, Lithuanian University of Health Sciences

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

7 maja 2026

Zakończenie podstawowe (Szacowany)

16 października 2027

Ukończenie studiów (Szacowany)

5 stycznia 2028

Daty rejestracji na studia

Pierwszy przesłany

4 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

9 maja 2026

Pierwszy wysłany (Rzeczywisty)

13 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

13 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

9 maja 2026

Ostatnia weryfikacja

1 maja 2026

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)?

TAK

Opis planu IPD

all IPD that underlie results in a publication

Ramy czasowe udostępniania IPD

July 2026-July 2027

Kryteria dostępu do udostępniania IPD

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.

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Implant placement

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