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

Peri-implant Soft Tissue and Bone Evaluation of One Abutment One Time Concept Following Fully Computer Guided Immediate Implants

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Soft Tissue Healing
• Intervention / Treatment: Procedure: guided immediate implant surgery

Detailed Description

Patient selection:

The study will be conducted on total of 16 patients recruited from the outpatient clinic of Oral Medicine, Periodontology, Oral Diagnosis and Radiology department, Faculty of Dentistry, Ain-Shams University. Sixteen consecutive healthy male/female patients with single non restorable remaining maxillary root from the right second premolar to the left second premolar will be added to the study.

Sample size analysis :

A sample size of 14 (7 in each group) will be sufficient to detect an effect size of approximately 1.75, with a power (1-β error) of 0.8 (80%) using a two-sided hypothesis test, with a significance level (α error) 0.05 for data. G power program version 3.1.9.2 was used for sample size calculation.This was increased to 8 patients in each group to make up for lost follow up cases The procedure will be explained to all patients and an informed consent will be signed before their inclusion in the study.

These patients will be divided randomly into 2 groups:

Group I: will include 8 patients who will undergo guided immediate implant placement and immediate provisionalization with preplanned PMMA provisional restoration on Ti-Base Group II: will include 8 patients who will undergo guided immediate implant placement and immediate loading by using a final CAD/CAM customized abutment and a cemented CAD/CAM fabricated PMMA provisional restoration.

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • faculty of Dentistry ASU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: immediate load with provisional restoration; immediate load with PMMA crown on Ti base	Procedure: guided immediate implant surgery; fully guided immediate implant placement and loading
Other: immediate load with one abutment one time concept; immediate ;load with customized final abutment and PMMA crown	Procedure: guided immediate implant surgery; fully guided immediate implant placement and loading

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Esthetic evaluation	Esthetic evaluation will be done by calculating the pink esthetic score (PES); standardized photographs are assesed to measure the changes in PES	4 months

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Director: 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 record dates

Study Major Dates

• Study Start (Actual): October 11, 2023
• Primary Completion (Actual): February 11, 2024
• Study Completion (Estimated): December 20, 2024

Study Registration Dates

• First Submitted: December 1, 2024
• First Submitted That Met QC Criteria: December 10, 2024
• First Posted (Estimated): December 13, 2024

Study Record Updates

• Last Update Posted (Estimated): December 13, 2024
• Last Update Submitted That Met QC Criteria: December 10, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Immediate implant; One abutment one time; Full digital workflow
• Other Study ID Numbers: FDASU.REC ID 032124

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No