Immediate Implant With Provisionalization

• Sponsor: University of Baghdad (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05006014
• Collaborator: (none)
• Enrollment: 35
• Location: 1
• Anticipated Duration (Months): 13.9
• Patients Per Site Per Month: 2.5

Study Details

Study Description

Brief Summary

Prospective observational clinical study conducted to evaluate the success of graftless immediate implantation with provisionalizaion

Condition or Disease	Intervention/Treatment	Phase
Maintain the Esthetic	Procedure: Tooth guided immediate implant placement

Detailed Description

In this study 35 graftless immediately placed implant in smile line loaded by provisional office made restoration, the primary and secondary stability measured and compared in addition to evaluation of pink esthetic score

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 35 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Primary Versus Secondary Implant Stability in Relation to Gap Distance of Immediate Implant With Immediate Loading by Provisional Restoration
• Actual Study Start Date: Jan 27, 2021
• Actual Primary Completion Date: Nov 27, 2021
• Anticipated Study Completion Date: Mar 27, 2022

Arms and Interventions

Arm	Intervention/Treatment
Patient with non restorable teeth Patient with non restorable teeth located in smile line needs extraction with immediate implantation and immediate provisionalization to improve psychiatric effect of tooth loss	Procedure: Tooth guided immediate implant placement; The technique of implant insertion consisted of a progressive preparation of the implant site using the anatomy of the root of the single rooted teeth to be extracted as a reference and as aid for apical engagement

Outcome Measures

Primary Outcome Measures

1. Implant primary stability [0 day]

   The stability measured by resonance frequancy analysis device (osstell)

2. Jumping gab [0 day]

   The gab that located between the implant surface and buccal plate

3. Pink esthetic score [0 day, before extraction and implant placement]

   Denote the esthetic profile of bone and gingiva

Secondary Outcome Measures

1. Implant secondary stability [Up to 16 weeks]

   The stability measured by resonance frequancy analysis device (osstell)

2. Ridge reduction [Up to 16 weeks]

   The amount of reduction in buccal profile of the alveolar ridge

3. Pink esthetic score [after implantation By 4 months]

   Denote the esthetic profile of bone and gingiva

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Medical and psychological fitness for minor oral surgery.

2. Age 20-60 years.

3. medium to thick gingival biotype.

4. buccal plate thickness more than (1mm).

Exclusion Criteria:

1. Smoking habit.

2. Diabetes mellitus.

3. A systemic disorder that is contraindicated for the minor surgical procedure.

4. Pregnancy or lactation.

5. Any irradiation in head and neck area.

6. Need for bone augmentation procedure.

7. Clinical signs of bruxism or other severe functional disorders.

8. patient with periodontal disease.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	College of dentistry	Baghdad	Bab Al Moatham	Iraq	11001

Sponsors and Collaborators

• University of Baghdad

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dalya Munther Naeem, Bachelor of dental surgery ( master student ), University of Baghdad
• ClinicalTrials.gov Identifier: NCT05006014
• Other Study ID Numbers: 1427705
• First Posted: Aug 16, 2021
• Last Update Posted: Mar 21, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: Yes

Study Results

No Results Posted as of Mar 21, 2022