NCT06653868

Brief Summary

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?

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 20, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 21, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 22, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2026

Completed
Last Updated

October 22, 2024

Status Verified

October 1, 2024

Enrollment Period

1.4 years

First QC Date

October 21, 2024

Last Update Submit

October 21, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • bone changes

    superimposition

    6 months

Secondary Outcomes (1)

  • pink esthetic score

    6 months

Study Arms (2)

immediate implant placement surgery with filling the gap distance with alloplastic sticky graft

EXPERIMENTAL

immediate implant placement surgery with filling the gap distance with injectable platelet rich fibrin combined with alloplast.

Procedure: dental implant with bone augmentation

immediate implant placement surgery with filling the gap distance with xenogenic sticky bone

EXPERIMENTAL

immediate implant placement surgery with filling the gap distance with injectable platelet rich fibrin combined with xenograft.

Procedure: dental implant with bone augmentation

Interventions

gap distance augmentation with bone graft

Also known as: gap distance augmentation
immediate implant placement surgery with filling the gap distance with alloplastic sticky graftimmediate implant placement surgery with filling the gap distance with xenogenic sticky bone

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with healthy systemic condition (Mazzotti et al., 2023).
  • Age from 20-50 years old
  • Patients must be free of any systemic disease which could influence the surgical procedure.
  • Tooth involved in the esthetic zone.
  • Sufficient hard and soft tissue volume in vertical and buccolingual direction
  • Natural teeth adjacent to the involved tooth will be required to be free from infection.
  • Controlled oral hygiene.
  • Indication for tooth extraction included (Degidi et al., 2012);
  • Endodontic failures
  • Untreatable caries
  • Non- restorable teeth
  • Vertical root fracture
  • Remaining roots

You may not qualify if:

  • \- 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.
  • Presence of acute dento-alveolar infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cairo University

Cairo, Egypt

RECRUITING

Cairo University

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Alveolar Bone Loss

Interventions

Dental Implants

Condition Hierarchy (Ancestors)

Bone ResorptionBone DiseasesMusculoskeletal DiseasesPeriodontal AtrophyPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental MaterialsBiomedical and Dental MaterialsDental ProsthesisProsthodonticsDentistryProstheses and ImplantsEquipment and SuppliesManufactured MaterialsTechnology, Industry, and Agriculture

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
bassant mohye

Study Record Dates

First Submitted

October 21, 2024

First Posted

October 22, 2024

Study Start

October 20, 2024

Primary Completion

March 20, 2026

Study Completion

March 20, 2026

Last Updated

October 22, 2024

Record last verified: 2024-10

Locations