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Loading Protocols for Dental Implants Placed in Healed Fully Edentulous Maxilla

2026년 5월 1일 업데이트: Aleksa Markovic, University of Belgrade

Immediate Vs Early Loading Protocols in Rehabilitation of Healed Fully Edentulous Maxilla

The goal of this clinical trial is to compare immediate versus early loading protocols for complete implant-supported fixed dental prostheses in healed edentulous maxillae.

The main questions it aims to answer are:

  • How does the timing of delivery of the prosthesis affect the stability of the implant and the surrounding soft and bone tissue?
  • Does prosthesis delivery time affect quality of life and patient satisfaction? Researchers will compare immediate and early (6 weeks after implant placement) loading protocols in rehabilitation of fully edentulous upper jaw.

Participants will:

  • Receive 6 dental implants in the edentulous upper jaw and after that complete fixed dental prostheses will be delivered immediately or 6 weeks after implant placement.
  • Visit the clinic at the scheduled time for checkups and tests

연구 개요

상태

모집하지 않고 적극적으로

상세 설명

Surgical protocol Prior to surgery antibiotic prophylaxis (2 g amoxicillin with clavulonic acid or, in case of allergy, 0.6 g clindamycin, 1 hour before the procedure) and antiedema therapy (0.004 g dexamethasone 1 hour before the procedure) was administered. Patients rinsed their mouth using 15 mL of 0.12% chlorhexidine solution for 1 minute preoperatively. The surgical procedures were performed under local anesthesia using 4% articaine, 1:100.000 epinephrine. Centers of the intended implant sites were marked according to the reference marks present in the patient's existing complete removable denture that had been used as the radiographic stent. A midcrestal incision was made, then full-thickness buccal and palatal flaps were elevated. Implant sites were prepared by strictly adhering to the manufacturer's protocol for low-density bone using drills of increasing diameter (Institut Straumann). To provide adequate primary implant stability, underpreparation was performed: 1. In low-density type D3 bone, the profile drill was skipped; and 2. In low-density type D4 bone, the final sequence and profile drills were skipped. Intermittent drilling under copious irrigation was performed with low hand pressure and a physiodispenser running between 600 and 800 rpm. A total of 144 sites were prepared, followed by placement of 144 SLActive surface (Bone Level Tapered, Institut Straumann) implants. Bone quality was assessed according to the Lekholm and Zarb classification. In sites with dehiscence or fenestration resulting in an exposed implant surface, localized bone augmentation was performed using bovine-derived xenograft (Geistlich Bio-Oss, Geistlich, Wolhusen, Switzerland) and covered with a type 1 collagen membrane (Geistlich Bio-Gide, Geistlich). Healing screws (Institut Straumann; NC healing abutment Ø4.8 mm conical 5 mm and RC healing abutment Ø5 mm conical 6 mm) were placed and primary wound closure was achieved with 5-0 single resorbable sutures (AssuCryl Lactin, Assut Sutures of Switzerland, Pully-Lausanne, Switzerland). Patients were discharged with recommendations regarding dietetic and hygienic regimens. Antibiotic protocol consisted of 2 g amoxicillin with clavulonic acid (divided into 2 doses) or, in case of allergy, 1.8 g clindamycin daily (divided into 3 doses) for the following 5 days. Antiedema therapy (0.004 g dexamethasone) was administered 24 hours postoperatively. Prosthetic protocol After dental implant placement, patients were randomly assigned to immediate loading or early loading groups.

Implants for patients from Test Group were immediately loaded using S-R abutments (Institut Straumann) with temporary restorations. Patients from Control Group did not receive any kind of prosthetic temporization and were left with healing abutments. For Test Group an open-tray impression technique was used for provisional restoration. Impressions were made using: ASilicone material (Hydrorise implant, Zhermack, Badia Polesine, Italy), splinted impression posts (RC and NC impression post, Straumann) and a plastic impression tray (Miratray, Hager Werken, Duisburg, Germany). Provisional restorations were made digitally with polymethyl methacrylate (PMMA) (Telio CAD, Ivoclar Vivadent, Schaan, Lichtenstein). Plaster models with scan bodies were digitized with a laboratory scanner (3Shape E1, 3Shape, Copenhagen, Denmark). Final virtual design of provisional restoration was performed with 3D design software (exocad Matera 2.3, Exocad, Darmstadt, Germany). Drilling of PMMA blocks was performed in a 5-axis milling machine (Zenotec Select, Wieland, Pforzheim, Germany). The following final Straumann screw retained abutments for the prosthetic bridge (Institut Straumann) were chosen according to implant angulation and surrounding soft tissue height. For the interface between the screw-retained abutments and final prosthetic work, copings for screw retained abutments (Institut Straumann) were used and bonded to the final prosthesis.

At the end of the 6-week healing period for both groups, definitive prosthetic restorations were delivered. In preparation for the definitive prosthesis, a final open-tray impression was taken with an individual tray and polyether material (Impregum Soft, 3M Espe, Seefeld, Germany). An analog ceramic layering technique was performed in the process of producing a porcelain fused to metal restoration (Shofu Vintage Halo Porcelain, Shofu Dental Corporation, Ratingen, Germany). The metal framework was made using cobalt chromium metal powder material (Starbond Easy Powder 45, Scheftner, Mainz, Germany) with additive manufacturing technologies (EOS, Krailling, Germany).

연구 유형

중재적

등록 (실제)

24

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

      • Belgrade, 세르비아, 11000
        • Implant Center, School of Dental Medicine, University of Belgrade

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

예

설명

Inclusion Criteria:

  1. Patients in good general health with no current history of systemic disease or medication use that could interfere with the treatment;
  2. Patients with complete maxillary edentulism who had lost their teeth at least 6 to 8 weeks prior to the proposed ''allon- six'' implant rehabilitation; and
  3. Clinically compliant patients consenting to be enrolled into the study.

Exclusion Criteria:

  1. Active or chronic disease that affects bone metabolism or wound healing;
  2. Diminished mental capacities that could mitigate the ability to comply with the protocol;
  3. Residual roots or teeth;
  4. History of maxillary augmentation;
  5. Oral carcinoma or inflammatory changes; and
  6. History of head and neck radiotherapy.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Immediately loading
Implants will be loaded with temporary prosthesis immediatelly after their insertion
Implants will be immediately loaded using S-R abutments (Institut Straumann) with temporary restorations. An open-tray impression technique was used for provisional restoration. Provisional restorations were made digitally with polymethyl methacrylate (PMMA) (Telio CAD, Ivoclar Vivadent, Schaan, Lichtenstein). Plaster models with scan bodies were digitized with a laboratory scanner (3Shape E1, 3Shape, Copenhagen, Denmark). Final virtual design of provisional restoration was performed with 3D design software (exocad Matera 2.3, Exocad, Darmstadt, Germany). Drilling of PMMA blocks was performed in a 5-axis milling machine (Zenotec Select, Wieland, Pforzheim, Germany). After 6 weeks they will receive final prosthesis.
다른 이름들:
  • 테스트 그룹
활성 비교기: Early loading
Implants will be left to heal with healing abutments for 6 weeks without prosthesis
At the end of the 6-week healing period, definitive prosthetic restorations were delivered. In preparation for the definitive prosthesis, a final open-tray impression was taken with an individual tray and polyether material (Impregum Soft, 3M Espe, Seefeld, Germany). An analog ceramic layering technique was performed in the process of producing a porcelain fused to metal restoration (Shofu Vintage Halo Porcelain, Shofu Dental Corporation, Ratingen, Germany). The metal framework was made using cobalt chromium metal powder material (Starbond Easy Powder 45, Scheftner, Mainz, Germany) with additive manufacturing technologies (EOS, Krailling, Germany).
다른 이름들:
  • 대조군

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Implant stability
기간: Implant stability will be measured at the time of implant placement (baseline) and at post-op week 6 (prior to delivery of definitive prosthetic restoration) and then after 5, 10 and 15 years
Implant stability will be recorded by Osstell Mentor and Penguin using Resonance frequency analysis (RFA) method. Results were recorded on an implant stability scale (ISQ) from 1 to 100. The higher the ISQ, the more stable the implant was.21 Two consecutive measurements delivering the same ISQ values were considered authentic.
Implant stability will be measured at the time of implant placement (baseline) and at post-op week 6 (prior to delivery of definitive prosthetic restoration) and then after 5, 10 and 15 years

2차 결과 측정

결과 측정
측정값 설명
기간
Insertion torque
기간: During surgery, at implant placement in prepared implant site.
Insertion torque was measured with a torque wrench (Institut Straumann) and recorded in Ncm.
During surgery, at implant placement in prepared implant site.
Marginal bone loss change from baseline to 5,10 and 15 years follow up
기간: At final prosthesis delivery (baseline), after 5,10 and 15 years follow up
Following prosthesis and multiunit abutment removal, standardized healing abutments (identical to baseline protocol) were placed. CBCT images were acquired at the same exposure parameters as baseline and analyzed by one blinded examiner using OnDemand3D software (Cybermed Inc., Seoul, South Korea). MBL was measured as the linear distance from the implant shoulder to first bone-implant contact at four sites per implant: mesial, distal, buccal, and palatal aspects.
At final prosthesis delivery (baseline), after 5,10 and 15 years follow up
Changes in Buccal Plate thickness from baseline to 5,10 and 15 years follow up
기간: At final prosthesis delivery (baseline) to 5,10 and 15 years follow up
Following prosthesis and multiunit abutment removal, standardized healing abutments (identical to baseline protocol) were placed. CBCT images were acquired at the same exposure parameters as baseline and analyzed by one blinded examiner using OnDemand3D software (Cybermed Inc., Seoul, South Korea). BPT was measured perpendicular to the implant axis at two locations: 2 mm apical to the implant-abutment connection and at implant midlength.
At final prosthesis delivery (baseline) to 5,10 and 15 years follow up
Oral health-related quality of life
기간: At implant placement (baseline), 1 month after definitive prosthesis delivery, and after 5,10 and 15 years
Oral health-related quality of life was evaluated using the OHIP-19 questionnaire. It consists of 19 questions and patients rated each item on a 5-point scale, where 0 indicated "never" and 4 indicated "constantly." The total OHIP-19 score was obtained by summing the scores from all questions. Lower score meant improved quality of life.
At implant placement (baseline), 1 month after definitive prosthesis delivery, and after 5,10 and 15 years
Patient satisfaction
기간: At implant placement (baseline), 1 month after final prosthesis delivery and after 5,10 and 15 years follow up.
Patients specified their level of satisfaction related to function, esthetics, and discomfort/pain by indicating a position along a 10-cm line between 2 endpoints where the beginning of the line was marked as complete unsatisfaction and the end as maximum satisfaction on Visual Analogue Scale.
At implant placement (baseline), 1 month after final prosthesis delivery and after 5,10 and 15 years follow up.
Implant survival rate
기간: 1 month after final prosthesis delivery, after 5, 10 and 15 years follow up
Implant survival was defined as implant in situ regardless of condition or peri-implant disease presence.
1 month after final prosthesis delivery, after 5, 10 and 15 years follow up
Prosthesis survival rate
기간: 1 month after final prosthesis delivery, after 5, 10 and 15 years follow up
Prosthesis survival was defined as original prosthesis in function with or without minor repairs.
1 month after final prosthesis delivery, after 5, 10 and 15 years follow up
Complications
기간: 1 month after final prosthesis delivery, after 5, 10 and 15 years follow up
Biological complications (implant failure requiring removal, peri-implantitis, peri-implant mucositis) and mechanical complications (prosthesis fracture, veneer chipping, screw loosening/fracture, abutment complications) were recorded.
1 month after final prosthesis delivery, after 5, 10 and 15 years follow up

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2019년 3월 1일

기본 완료 (추정된)

2035년 3월 1일

연구 완료 (추정된)

2035년 3월 1일

연구 등록 날짜

최초 제출

2026년 5월 1일

QC 기준을 충족하는 최초 제출

2026년 5월 1일

처음 게시됨 (실제)

2026년 5월 7일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 7일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 1일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

1 month, 5 years, 10 years and 15 years outcomes will be published in the journal.

IPD 공유 기간

2022-2036

IPD 공유 액세스 기준

The investigators will share analyzed outcomes, surgical and prosthetic protocols.

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • ICF

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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