Effect of Customized Healing Abutment on Soft Tissue Alterations Around Immediate Implant Placements With or Without Bone Graft Versus Connective Tissue Graft

August 29, 2023 updated by: Ahmed Aboulfettouh, Cairo University

Effect of Customized Healing Abutment on Soft Tissue Alterations Around Immediate Implant Placements With or Without Bone Graft Versus Connective Tissue Graft. A 1-Year Randomized Clinical Trial

Dimensional changes, including the loss of labial soft tissues and midfacial gingival recession, seem to be inevitable following immediate placement. The clinical relevance of this study is proposing a treatment modality namely customized healing abutment with immediate implant placement that is proposed to minimize and control midfacial gingival recession and support buccal soft tissue contour, and maintain long term stability of these tissue, which might enhance the esthetics

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Tooth extraction is followed by ridge alteration and soft tissue collapse and recession. Different strategies were proposed to limit this collapse however, the ability of these techniques to mimic the original soft tissue level and to maintain long term stability is unclear (Slagter et al., 2014). Using customized contoured healing abutments at the time of immediate implant placement is a treatment modality to improve esthetics by maintaining the soft tissue level and contour (Ruales-Carrera et al, 2019, Perez et al, 2020). Using connective tissue grafts has been suggested to enhance and maintain soft tissue stability, however, the effect of the combined procedures for maintenance of the soft tissue morphology compared to customized healing abutments alone remains unclear (Atieh et al, 2019).

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • IDCE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patient-related criteria:

    • Adults at or above the age of 18.
    • Non-restorable maxillary anterior or premolar tooth requiring extraction and needed an implant placing therapy.
    • The failing tooth will have adjacent and opposing natural teeth.
    • Sufficient mesial-distal and interocclusal space for placement of the implant and definitive restoration.
    • Able to tolerate surgical periodontal procedures.
    • Good oral hygiene.
    • Compliance with the maintenance program.
    • Provide informed consent.
    • Accepts the one-year follow-up period.

Teeth related criteria:

  • Intact thick biotype gingival tissue with at least 2mm band of keratinized tissue.
  • Intact socket wall before the extraction, buccal bone thickness ≤1mm assessed by CBCT.
  • Sufficient apical bone to place an immediate implant with minimum primary stability of 30Ncm

Exclusion Criteria:

  • Patients diagnosed with periodontal diseases.
  • Current or previous smokers.
  • Pregnant and lactating females.
  • Patients with medical conditions that would compromise the surgical procedures; uncontrolled diabetes mellitus, taking IV Bis-phosphonates for treatment of osteoporosis.
  • Patients with active infection related at the site of implant/bone graft placement.
  • Patients with parafunctional habits

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: immediate implant placement with bone grafts till crest
Group1 (control group): immediate implant placement with bone grafts till crest and customized healing abutment.
Procedure: Connective tissue graft /Bone graft/ Customized HA
Soft tissue management and augmentation
Other Names:
  • Customized Healing abutment
Experimental: immediate implant placement with customized healing abutment
Group 2 (intervention 1 group): immediate implant placement with customized healing abutment
Procedure: Connective tissue graft /Bone graft/ Customized HA
Soft tissue management and augmentation
Other Names:
  • Customized Healing abutment
Experimental: immediate implant placement with CTG and customized healing abutment.
Group 3 (intervention 2 group): immediate implant placement with CTG and customized healing abutment.
Procedure: Connective tissue graft /Bone graft/ Customized HA
Soft tissue management and augmentation
Other Names:
  • Customized Healing abutment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mid facial recession
Time Frame: 12 months
will be assessed by measuring the distance between level of soft tissues at mid-facial gingival level of the implant site and a reference line, which connected the facial soft tissue level of the adjacent teeth, at baseline, 3, 6 and 12 months of follow up.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bucco-palatal bone width
Time Frame: 12 months
Two CBCT scans will be done, primary (preoperative) scan and secondary (Postoperative) scan 12 months after, using Cranex ® SOREDEX, Finland.
12 months
Volumetric analysis of buccal contour
Time Frame: 12 months
To evaluate tissue volume changes in the buccal soft tissue contour in comparison to the original ones, at 2,4 and 6 mm from the pre-operative gingival margin, at 3, 6 and 12 months and will be compared to the presurgical scanned casts
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2022

Primary Completion (Actual)

April 30, 2023

Study Completion (Actual)

May 30, 2023

Study Registration Dates

First Submitted

July 27, 2023

First Submitted That Met QC Criteria

August 2, 2023

First Posted (Actual)

August 4, 2023

Study Record Updates

Last Update Posted (Actual)

August 30, 2023

Last Update Submitted That Met QC Criteria

August 29, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • PER 2612

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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