Clinical trial NCT04329156: Evaluation Of Peri-Implant Emergence Profile Conditioned With Two Different Prosthetic Techniques
Official title: Evaluation Of Peri-Implant Emergence Profile Conditioned With Two Different Prosthetic Techniques (Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Implants
Lead sponsor: University of Alexandria
Sponsor class: OTHER
Collaborators: name: Alexandria University
First posted: 2020-04-01
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate and compare two prosthetic conditioning techniques to create natural-like peri-implant emergence profile.

Detailed description: Twenty four patients having a non-restorable tooth will be rehabilitated with flapless immediate implant placement after tooth extraction. The emergence profile will be conditioned with either a stock or a customized healing abutment. A definitive screw retained restoration will be inserted 4 months postoperatively. Peri-implant tissues will be evaluated using pink and white esthetic score, radiographs and periodontal parameters at 3,6 and 12 months after implant placement.

Eligibility criteria: Inclusion Criteria:

* Presence of non-restorable maxillary anterior or premolar tooth and its healthy contra-lateral.
* The gingival contour of the tooth to be extracted should be in harmony with the healthy contra-lateral tooth.
* Having thick gingival biotype.

Exclusion Criteria:

* Any medical disorder that could interfere with osseointegration or soft tissue healing.
* Active oral infections or periodontal disease.
* Presence of dehiscence or fenestration defects related to the tooth to be extracted.
* Poor oral hygiene.
* Heavy smokers (\>10 cigarette / day).

Primary outcomes:
measure: Pink esthetic score (PES)
timeFrame: 3 months
measure: Pink esthetic score (PES)
timeFrame: 6 months
measure: Pink esthetic score (PES)
timeFrame: 12 months
measure: White esthetic score (WES)
timeFrame: 6 months
measure: White esthetic score (WES)
timeFrame: 12 months
measure: Peri-implant Probing Depth (PD)
timeFrame: 3 months
measure: Peri-implant Probing Depth (PD)
timeFrame: 6 months
measure: Peri-implant Probing Depth (PD)
timeFrame: 12 months
measure: Modified Sulcus Bleeding Index (BI)
timeFrame: 3 months
measure: Modified Sulcus Bleeding Index (BI)
timeFrame: 6 months
measure: Modified Sulcus Bleeding Index (BI)
timeFrame: 12 months
measure: Modified Plaque Index (PI)
timeFrame: 3 months
measure: Modified Plaque Index (PI)
timeFrame: 6 months
measure: Modified Plaque Index (PI)
timeFrame: 12 months
measure: Radiographic evaluation of alveolar bone using cone beat computed tomography (CBCT)
timeFrame: 3 months
measure: Radiographic evaluation of alveolar bone using cone beat computed tomography (CBCT)
timeFrame: 6 months
measure: Radiographic evaluation of alveolar bone using cone beat computed tomography (CBCT)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Muhammed Badee, M.Sc
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Mohamed M Khamis, PhD
role: STUDY_CHAIR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Ahmed A Abdelhakim, PhD
role: STUDY_CHAIR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Rania Abdelaziz, PhD
role: STUDY_CHAIR
References: