Titanium Versus Nano-Carbon CAD/CAM Frameworks for All-on-4 Implant Supported Hybrid Prosthesis.
Titanium Versus Nano-Carbon CAD/CAM Frameworks for All-on-4 Implant Supported Hybrid Prosthesis. A Study of Peri-implant Tissue Changes and Prosthetic Complications
This clinical study compares two CAD/CAM framework materials, titanium and nano-carbon fiber-reinforced composite, used in mandibular All-on-4 implant-supported hybrid prostheses. Patients are randomly allocated into two equal groups, with 10 patients in each group. The study evaluates peri-implant soft tissue health, changes in marginal bone levels, and prosthetic complications overa12-month follow-up period.
연구 개요
상태
정황
상세 설명
Completely edentulous patients receive four mandibular implants according to the All-on-4 concept, with two anterior axial implants and two posterior tilted implants placed anterior to the mental foramina. Patients are randomly allocated to receive either a CAD/CAM-milled titanium framework or a nano-carbon fiber-reinforced framework. Clinical follow-up includes assessment of modified plaque index, modified gingival index, probing depth, and bleeding index. Marginal bone level changes are assessed radiographically at 6 and 12 months after insertion of the fixed prosthesis. Prosthetic complications are also evaluated.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Dakahlia Governorate
-
Al Mansurah, Dakahlia Governorate, 이집트
- Faculty of Dentistry, Mansoura University
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
-
* Completely edentulous patients requiring mandibular implant-supported rehabilitation.
- Adequate bone quantity and quality in the mandibular interforaminal region for implant placement.
- Adequate restorative space for an implant-supported hybrid prosthesis.
- Healthy oral mucosa and acceptable oral hygiene.
- Patients medically fit to undergo implant surgery.
- Ability and willingness to attend the scheduled follow-up visits and provide informed consent.
Exclusion Criteria:
- Systemic conditions or medical contraindications that could interfere with implant surgery or healing.
- History of radiotherapy to the head and neck region.
- Smoking.
- Alcohol abuse.
- Bruxism or clenching habits.
- Any local condition that could compromise implant placement or the planned prosthetic rehabilitation.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: Titanium Framework Group
Participants received mandibular All-on-4 implant-supported hybrid prostheses fabricated with a CAD/CAM-milled titanium framework. |
CAD/CAM-milled titanium framework used for mandibular All-on-4 implant-supported hybrid prosthesis. |
|
실험적: Nano-Carbon Framework Group
Participants received mandibular All-on-4 implant-supported hybrid prostheses fabricated with a Nano-carbon fiber-reinforced CAD/CAM framework. |
Nano-carbon fiber-reinforced CAD/CAM framework used for mandibular All-on-4 implant-supported hybrid prosthesis. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Marginal bone level change
기간: At prosthesis insertion (T0), 6 months (T6), and 12 months (T12)
|
Radiographic assessment of changes in peri-implant marginal bone level around the implants in the titanium and nano-carbon framework groups. |
At prosthesis insertion (T0), 6 months (T6), and 12 months (T12)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Modified plaque index
기간: At prosthesis insertion (T0), 6 months (T6), and 12 months (T12)
|
Assessment of plaque accumulation around the implants using the modified plaque index |
At prosthesis insertion (T0), 6 months (T6), and 12 months (T12)
|
|
Modified gingival index
기간: At prosthesis insertion (T0), 6 months (T6), and 12 months (T12)
|
Assessment of peri-implant gingival tissue condition using the modified gingival index |
At prosthesis insertion (T0), 6 months (T6), and 12 months (T12)
|
|
Probing depth
기간: At prosthesis insertion (T0), 6 months (T6), and 12 months (T12)
|
Measure of per-implant probing depth around the implants |
At prosthesis insertion (T0), 6 months (T6), and 12 months (T12)
|
|
Bleeding index
기간: At prosthesis insertion (T0), 6 months (T6), and 12 months (T12)
|
Assessment of peri-implant bleeding using the bleeding index |
At prosthesis insertion (T0), 6 months (T6), and 12 months (T12)
|
|
prosthetic complications
기간: up to12 months after prosthesis insertion
|
Assessment of prosthetic complications and maintenance requirements associated with the implant supported prosthesis |
up to12 months after prosthesis insertion
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- A0102024RP
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Individual participant data are not planned to be shared because the study was conducted as part of an academic doctoral research project and no data-sharing plan was established in the approved protocol.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .