Immediate Implant With Different Filling Materials

• Sponsor: Mansoura University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05878392
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Arms: 3
• Actual Duration (Months): 12
• Patients Per Site Per Month: 3

Study Details

Study Description

Brief Summary

36 patients, were included in this study. They were chosen from the Outpatient Clinic in the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University for replacement of non-restorable maxillary anterior and premolar teeth (esthetic zone) by immediate implant.

Condition or Disease	Intervention/Treatment	Phase
Immediate Implant	Other: bone filling materials	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Comparison Between Different Filling Materials in Immediate Implant
• Actual Study Start Date: Jan 1, 2022
• Actual Primary Completion Date: Jun 1, 2022
• Actual Study Completion Date: Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: group 1 immediate implant placement and the buccal jumping gap was packed using PRF	Other: bone filling materials; the buccal jumping gap was packed using PRF in group 1 the buccal jumping gap was packed using xenograft in group 2 the buccal jumping gap was packed using Alloplastic β-tricalcium phosphate in group 3
Experimental: group 2 immediate implant placement and the buccal jumping gap was packed using xenograft	Other: bone filling materials; the buccal jumping gap was packed using PRF in group 1 the buccal jumping gap was packed using xenograft in group 2 the buccal jumping gap was packed using Alloplastic β-tricalcium phosphate in group 3
Experimental: group 3 immediate implant placement and the buccal jumping gap was packed using alloplast	Other: bone filling materials; the buccal jumping gap was packed using PRF in group 1 the buccal jumping gap was packed using xenograft in group 2 the buccal jumping gap was packed using Alloplastic β-tricalcium phosphate in group 3

Outcome Measures

Primary Outcome Measures

1. marginal bone loss [1 year]

   Cone Beam CT (CBCT) was used measure marginal bone loss

Secondary Outcome Measures

1. Implant Stability: [1 year]

   Resonance frequency analysis (RFA) was used to measure implant stability with an Osstell Mentor device.

2. Peri-implant Pocket depth [1 year]

   A graduated probe was used to measure the distance between the base of the pocket and the gingival margin

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Patient medically free from systemic diseases.

• Age above 18 years.

• A single maxillary anterior or premolar tooth that cannot be restored.

• No acute infection is present.

• Patients with sufficient quality and quantity of bone.

• Free from history of bruxism.

Exclusion Criteria:

• A medical condition that would prevent implant surgery.

• Existence of non-treated generalized progressive periodontitis.

• Patients who are smokers.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Heba Elsheikh	Mansoura, Egypt		Egypt	002

Sponsors and Collaborators

• Mansoura University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mansoura University
• ClinicalTrials.gov Identifier: NCT05878392
• Other Study ID Numbers: A0103023OS
• First Posted: May 26, 2023
• Last Update Posted: May 26, 2023
• Last Verified: May 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of May 26, 2023