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Evaluation of the Accuracy of Root Guided Immediate Implant Placement at Maxillary- Molar Region

2026년 6월 14일 업데이트: Abeer Rizk Zakaria Nasef, Tanta University
Twenty patients with non restorable maxillary molar that indicate to immediate implant will be included in this study. The patients will be divided randomly (10 patients each group). Group I(study),immediate implant placement will be done using root guide technique.Group II(control),immediate implant placement will be done using surgical guide technique.The patients will be received, clinically and radiologically examined, and managed at the Oral and Maxillofacial surgery Department,Faculty of Dentistry, Tanta University.The patients will be evaluated clinically to evaluate healing and radio graphically using cone beam CT (CBCT) scan to identify bone density post operative and after 6 months.

연구 개요

상세 설명

Purpose: This study aimed to evaluate the accuracy of the root guide technique in comparison to the surgical guide technique for immediate implant placement in the maxillary- molar region radiographically and clinically.

Materials & Methods:Twenty patients with non restorable maxillary molar will be included in this study. The patients will be divided randomly (10 patients each group). Group I,immediate implant placement will be done using root guide technique.Group II,immediate implant placement will be done using surgical guide technique.The patients will be received, clinically and radiologically examined, and managed at the Oral and Maxillofacial surgery Department,Faculty of Dentistry, Tanta University.The patients will be evaluated clinically to evaluate healing and radio graphically using cone beam CT (CBCT) scan to identify bone density post operative and after 6 months.

Preoperative evaluation: The patients will be evaluated clinically and radiographically using Cone beam CT(CBCT) scan , before implant placement for assessment of the anatomy of inter-radicular septum and tooth roots ,periapical pathology , bone density and approximation of vital structures , then we will make virtual planning to future implant position.

  • fabrication of surgical guide stent( tooth born ): will be done for Group II, Conventional impression will be taken with irreversible hydrocolloid to make a diagnostic cast.

    • The cast will be scanned with a laboratory scanner.
    • -The scanned data of the cast will exported as a standard tessellation language (STL) file, while the CBCT image will saved as Digital Imaging and Communications in Medicine (DICOM) data 26 .
    • -Design of the surgical guide proceeded with superimposition of the STL file to the CBCT data through a software [Blue Sky software].⃰
    • -Completion of virtual implant treatment planning with proper adjustment, the adequate position of the implant will planned with the creation of open sleeve.
    • -Selection and fabrication of surgical guide based on the computed tomography model and print it by Creality LD006 ⃰⃰

Surgical procedure:

Stage 1:

Group I:

All patients will undergo the surgery under local anesthesia. We will do coronctomy to the level of free gingiva and separation of the roots with surgical fissure bur ,drilling the implant site according to manufacture's proptocl will be done with roots intact in their sockets within the inter-radicular bone. Clinically visible roots will be extracted by using periotomes .Following extraction, the socket will be debrided to remove any reminants and the socket and osteotomy will be irrigated by sterile normal saline . The implant will be inserted into the site following manufacture's protocol.

GroupII All patients will undergo the surgery under local anesthesia. Surgical separation of the roots will be done by surgical fissure bur , separated roots will be extracted by periotomes , the socket will be debrided to remove any reminants and irrigated by sterile normal saline. Following extraction, drilling the implant site will be done through the surgical guide (tooth supported surgical guide) according to manufacturer's protocol, implant will be inserted into the site following manufactures protocol.

- After insertion of the implant in both groups: the primary stability will be measured by Osstell device (resonance frequency analyzer, (RFA) is a device that uses resonance frequency analysis to measure implant stability quotient (ISQ)) , then we will fill the gap between the implant and walls of the socket by bone graft graft(xenogeneic bone graft) and PRF (platelets- rich fibrin) around the implant into the socket , finally custom mad haling abutment will b made.

Postoperative evaluation: The patients will be evaluated clinically regarding healing, presence of inflammation,and swelling each week at the first month then after 3 months and 6 months and assess pain, by Visual Analog Scale weekly during the first month (at days 1,7, and14). . Implant stability will be assessed at the time of implant insertion and 6 months after the operation.

Radiographically,During the follow-up period a CBCT will be taken immediately postoperative and 6 months after the operation.

Immediate CBCT was to compare the actual position of the implant with the preoperative virtual planning of the implant position by superimposition of preoperative and postoperative CBCT. Three deviation parameters between each planned and placed implant were measured :

  • Horizontal deviation at coronal side of the implant.
  • Horizontal deviation at apex of the implant
  • Angular deviation. All measurements were performed using Mimics Innovation Suite 19tm software.

Stage II( crest module uncoverage and healing abutment installation).:

After 6 months of consolidation and osseointegration period, CBCT was done to assess the oseteointegration . A surgical re-entry procedure performed to allow access to the crest module of the fixture.

Prior to the start of surgery, the patient rinsed his mouth with betadine for 1 min. The oral cavity was scrubbed with betadine (povidine iodine 2.5%) antiseptic solution.

Under local anesthesia ,custom made healing abutment was removed to exposure the implant . Smart peg was installed at the fixture level to assess secondary implant stability before loading.A healing abutment selected according to the soft tissue thickness installed until gingival collar becomes adequate around the implant.

.

연구 유형

중재적

등록 (추정된)

20

단계

  • 해당 없음

연락처 및 위치

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

연구 장소

      • Tanta, 이집트, 3111
        • faculty of dentistry, Tanta university

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

건강한 자원 봉사자를 받아들입니다

예

설명

Inclusion Criteria:

  • • Patients with non-restorable maxillary molars.

    • Age of patients above 18 years old.
    • Good oral hygiene.
    • Healthy covering keratinized oral mucosa.

Exclusion Criteria:

  • • Patients with systemic disease that may affect bone healing.

    • Periapical pathosis.
    • Heavy smoker patients(>14 cigarettes per day).

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: Root guide technique
ten patients with non restorable maxillary molar which indicated to immediate implant were treated by using root guide technique for placement of immediate implant . Drilling the implant site according to protocol of manufacture was done with roots intact in their sockets within the inter-radicular bone
group I ten patients with non restorable maxillary molar will be undergo placement of immediate implant by using root guide for drilling of the ostoetomy site.
실험적: surgical guide technique
ten patients with non restorable maxillary molar which indicated to immediate implant were treated by using surgical guide.Drilling the implant site according to protocol of manufacture was done through the surgical guide after extraction of roots.
group II ten patients with non restorable maxillary molar will be undergo placement of immediate implant by using surgical guide for drilling of the ostoetomy site.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
degree of pain
기간: one-two weeks
degree of pain evaluated clinically in both groups using visual analogue scale:0 represent no pain and 10 represents the highest level of pain
one-two weeks
soft tissue healing
기간: one week
soft tissue healing evaluated clinically in both groups presence of dehiscence and exposure of bone or not
one week
infection
기간: one week-one month
infection evaluated clinically in both groups presence of signs of infection or not
one week-one month
density of bone
기간: six months]
density of bone calculated radiographically in both groups CBCT
six months]

2차 결과 측정

결과 측정
측정값 설명
기간
inflammation
기간: one week
inflammation clinically in both groups 0 no inflammation 1-3 mild inflammation 4-7 moderate inflammation 8-10 sever inflammation
one week

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

수사관

  • 수석 연구원: Abeer R Nasef, doctor, Tanta Universality

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)

2025년 3월 22일

기본 완료 (추정된)

2026년 6월 30일

연구 완료 (추정된)

2026년 7월 10일

연구 등록 날짜

최초 제출

2026년 6월 14일

QC 기준을 충족하는 최초 제출

2026년 6월 14일

처음 게시됨 (실제)

2026년 6월 18일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 18일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 14일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • 2243

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