Grafting of the Peri-implant Bony Defects Around Immediate Implants Using Xenogenic Versus Alloplastic Sticky Grafts: Randomized Controlled Clinical Trial

In patients with a single non restorable tooth, does filling the peri-implant buccal gap with alloplastic sticky grafts result comparable results compared to xenogenic sticky grafts?

Study Overview

• Status: Recruiting
• Conditions: Bone Loss, Alveolar
• Intervention / Treatment: Procedure: dental implant with bone augmentation

Detailed Description

The buccal aspect of the dental implant has great importance, especially in the aesthetic zone, because the buccal bone is very thin especially in the anterior maxilla and its resorption can result in recession of the soft tissue. A gap occurs in immediately placed implant due to discrepancy between the dimensions of the extraction socket and the implant. Augmentation of the buccal gap decreases the amount of buccal bone resorption and soft tissue recession . Filling the peri-implant defects has been widely discussed to prevent further bone loss. The use of biologic materials such as platelet rich fibrin can enhance the quality of alloplastic bone grafts to give comparable effect when compared to xenogenic grafts.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Cairo university
    • Contact: bassant mohye, phd candidate; Phone Number: 01006744545; Email: bassant_mohye@hotmail.com
    • Contact: cairo university; Phone Number: 0223646375; Email: rec@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Patients with healthy systemic condition (Mazzotti et al., 2023).
2. Age from 20-50 years old
3. Patients must be free of any systemic disease which could influence the surgical procedure.
4. Tooth involved in the esthetic zone.
5. Sufficient hard and soft tissue volume in vertical and buccolingual direction
6. Natural teeth adjacent to the involved tooth will be required to be free from infection.
7. Controlled oral hygiene.

8. Indication for tooth extraction included (Degidi et al., 2012);

   • Endodontic failures
   • Untreatable caries
   • Non- restorable teeth
   • Vertical root fracture
   • Remaining roots

Exclusion Criteria:

- 1.Pregnant females 2.Smokers (Khuller, 2009) 3.Unmotivated and uncooperative patients with poor oral hygiene 4.Patients with habits that may compromise the longevity and affect the result of the study as alcoholism or parafunctional habits.

5.Presence of acute dento-alveolar infection.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: immediate implant placement surgery with filling the gap distance with alloplastic sticky graft; immediate implant placement surgery with filling the gap distance with injectable platelet rich fibrin combined with alloplast.	Procedure: dental implant with bone augmentation; gap distance augmentation with bone graft; Other Names: gap distance augmentation
Experimental: immediate implant placement surgery with filling the gap distance with xenogenic sticky bone; immediate implant placement surgery with filling the gap distance with injectable platelet rich fibrin combined with xenograft.	Procedure: dental implant with bone augmentation; gap distance augmentation with bone graft; Other Names: gap distance augmentation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
bone changes	superimposition	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pink esthetic score	soft tissue esthetics	6 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): October 20, 2024
• Primary Completion (Estimated): March 20, 2026
• Study Completion (Estimated): March 20, 2026

Study Registration Dates

• First Submitted: October 21, 2024
• First Submitted That Met QC Criteria: October 21, 2024
• First Posted (Actual): October 22, 2024

Study Record Updates

• Last Update Posted (Actual): October 22, 2024
• Last Update Submitted That Met QC Criteria: October 21, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Alveolar Bone Loss
• Other Study ID Numbers: per631

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

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