Peri-implant Soft Tissue and Bone Evaluation in Fully Computer Guided Immediate Implants

NCT06733870 | Active Not Recruiting DMC

• 1 other identifier: FDASU.REC ID 032124
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective evaluation of perimplant soft tissue and bone response to one abutment one-time concept versus provisional abutment in fully guided single immediate implant placement.

Conditions

Soft Tissue Healing

Keywords

One abutment one time; Full digital workflow; Immediate implant

Outcome Measures

Primary Outcomes (1)

• peri-implant soft tissue volumetric change

  * intraoral scanner is used to obtain before and after 3D scans * 3D scans are superimposed on a software and the difference in volume can be measured and detected by a color map

  4 months

Secondary Outcomes (1)

• Esthetic evaluation

  4 months

Study Arms (2)

immediate load with provisional restoration

OTHER

immediate load with PMMA crown on Ti base

Procedure: guided immediate implant surgery

immediate load with one abutment one time concept

OTHER

immediate ;load with customized final abutment and PMMA crown

Procedure: guided immediate implant surgery

Interventions

guided immediate implant surgery PROCEDURE

fully guided immediate implant placement and loading

immediate load with one abutment one time concept; immediate load with provisional restoration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females aged at least 18 years.
• Patients free from any systemic disease as evidenced by health questionnaire - - Single tooth failure of a maxillary anterior region (incisors, canines, and premolars) with neighbouring teeth present and healthy periodontal conditions.
• Intact socket walls evident on cone beam computed tomography and confirmed on the day of extraction.
• Natural teeth present adjacent to the tooth being replaced in addition to a natural counterpart tooth present for esthetics criteria evaluation.
• Adequate bone apical to the tooth to be replaced with a minimum primary stability of 30 Ncm.
• Thick gingival biotype.

You may not qualify if:

• Presence of active infection around the failing tooth or adjacent teeth.
• Presence of active periodontal disease and gingival recession in the esthetic area.
• Systemic diseases , pregnancy and smoking.
• Recent orthodontic treatment.
• Bruxism and parafunctional habits .
• Labial plate dehiscence, fenestration, or loss after tooth extraction
• Inability to achieve primary stability after implant placement
• Vulnerable groups: prisoners, mentally retarded, etc

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

faculty of Dentistry ASU

Cairo, Egypt

Location

Study Officials

• Mohamed Bissar, Associate professor

  Faculty of dentistry- Ain Shams University

  STUDY DIRECTOR

• Ingy Nouh, lecturer

  Faculty of dentistry- Ain Shams University

  STUDY DIRECTOR

• Hala Kamal, Professor

  Faculty of dentistry- Ain Shams University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: December 1, 2024
• First Posted: December 13, 2024
• Study Start: October 11, 2023
• Primary Completion: February 11, 2024
• Study Completion: December 20, 2024
• Last Updated: December 13, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)