Volumetric Changes of Labial Soft Tissue Contour Following Different Approaches with Immediate Implant Placement

November 19, 2024 updated by: Ahmed Abo El Futtouh, Misr International University

Hard and Soft Tissue Alterations on the Use of Dual Zone Concept Versus Connective Tissue Graft At Flapless Maxillary Immediate Implant Placement. a 1-year Randomized Clinical Trial and Volumetric Study.

Statement of the problem: Tooth extraction is followed by ridge alteration and soft tissue contour collapse. Different strategies were proposed to limit this collapse however, the ability of these techniques to mimic the original soft tissue contour and to maintain long term stability is unclear. Purpose : The aim of this study is to evaluate the volumetric difference of buccal soft tissue contour as well as the radiographic changes, following tooth extraction and immediate implant placement with dual zone concept versus connective tissue graft. Materials and Methods: Thirty patients with single maxillary anterior or premolar tooth indicated for extraction will participate in this study, 15 patient in each group. Group 1 (test group) will be treated by immediate implant placement (IIP) with particulate bone grafts in the dual zone (the bone zone and the tissue zone) and customized healing abutment. Group 2 (control group) IIP with connective tissue graft (CTG) and customized healing abutment. Patient allocation is random for the 2 groups. Data will be collected pre-surgically and at follow up periods (3,6,9&12 months and 6 months after delivery). Extra-oral scanning of the labial contour will be carried out to evaluate difference in contour gained and will be compared to the original contour and between treatment groups. Radiographic evaluation will be done using CBCT pre-operatively and at 12 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After administration of local anaesthesia, the tooth will be extracted by the principle investigator without raising flaps, as atraumatically as possible by using periotomes without disturbing the papillary tissues (minimal traumatic extraction technique). After the extraction of the tooth, the socket will be carefully cleaned to excavate the granulation tissue in the marginal and apical regions. The allocation will be revealed to the principle investigator for the 3 implant groups after implant placement.

Group 1: extraction will occur and then followed by immediate implant placement,using standard implant system protocol preparation of the osteotomy will take place. Initial drill will be placed palatally till final drill reached. Placement of the implant without any raising of the flap will be performed in the correct implant position. Primary stability of the implant will be measured by rotational insertion torque value, to be ≥30Ncm (37). Particulate bone grafts are packed in the gap between the implant and the buccal plate of bone and the tissue (dual zone), Followed by customized healing abutment, the temporary cylindrical abutment twill be screwed to the implant and then flowable composite will be injected at the gingival margin level to adapt to the abutment that will be sand-blasted previously for mechanical retention of the composite, taking the shape of the socket at the marginal gingiva, but will only seal the socket without extending deeper apically in the soft tissue. A buccal groove will be made after the polymerization of this material for easier application. The abutments will be removed for final configurations of the apical part mimicking the emergence profile of the extracted tooth and finishing with laboratory discs and burs. The custom healing screw will then be screwed to the implant with the correct torque.

Group 2: Tooth extraction and immediate implant placement as mentioned. Connective tissue grafts will be harvested from the hard palate and placed at the implant sites in a supraperiosteal partial dissection (pouch technique) prepared at the buccal aspect without using vertical incisions and without flap elevation. Sutures will be used to stabilize the graft in its desired place, then will be covered by a customized healing abutment that will be done as mentioned before.

Study Type

Interventional

Enrollment (Actual)

30

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
        • Misr International University
      • Cairo, Egypt
        • International Dental Contining Education Centre (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

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Patients who have at least one non-restorable maxillary anterior or premolar tooth with sound adjacent teeth.
  2. Adults at or above the age of 18.
  3. Intact thick biotype gingival tissue with at least 2mm band of keratinized tissue.
  4. Buccal bone thickness should be 1mm or less assessed in CBCT with good apical bone.
  5. Sagittal root position type 1 as described by Kan et al(30).
  6. Good oral hygiene
  7. Patient accepts to provide an informed consent.

Exclusion Criteria:

  1. Smokers
  2. Pregnant and lactating females.
  3. Medically compromised patients. , as Uncontrolled diabetic patients, patients taking bisphosphonates injection for treatment of osteoporosis, patients with active cardiac diseases, patients undergoing radiotherapy or chemotherapy, or any other medical and general contraindications for the surgical procedure (i.e. ASA score ≥III) (31)
  4. Patients with active infection related at the site of implant/bone graft placement.
  5. Patients with untreated active periodontal diseases.
  6. 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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dual zone concept and customized healing abutment
Immediate implant placement with bone grafts in the dual zone and customized healing abutment.
Procedure: Dual zone concept and customized healing abutment
Immediate implant placement without flap raising using standard implant system protocol preparation will take place. Followed by bone grafting following dual zone concept and customized healing abutment.
Other Names:
  • zimmer biomed dental implants and dual zone bone grafting and customized healing abutments
Active Comparator: Connective tissue graft and customized healing abutment
immediate implant placement with CTG and customized healing abutment
Procedure: Connective tissue graft and customized healing abutment
Immediate implant placement without flap raising using standard implant system protocol preparation will take place. Connective tissue grafts from the hard palate will be placed at the implant sites in a supraperiosteal partial dissection prepared at the buccal aspect. Sutures will be used to stabilize the graft, followed by customized healing abutment. Flowable composite will be injected at the gingival margin level to adapt to the sandblasted abutment, taking the shape of the socket at the marginal gingiva. Buccal groove will be made after the polymerization of this material for easier application. The abutments will be removed for final configurations of the apical part mimicking the emergence profile of the extracted tooth and finishing with laboratory discs and burs. The custom healing screw will be screwed to the implant.
Other Names:
  • zimmer biomed dental implants and connective tissue grafts and customized healing abutments

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pink Esthetic Score (PES)
Time Frame: 6 months after delivery (18 months after IIP)
The PES is based on seven parameters; mesial papilla, distal papilla, soft-tissue level, soft tissue contour, alveolar process deficiency, soft-tissue color, and texture. The peri-implant mucosa will be evaluated by the seven index points. The grading using the PES suggested by Fürhauser will be performed. The contralateral tooth and the adjacent soft tissue served as reference using a 0-1-2 scoring system, with 0 being the lowest and 2 being the highest value (Fürhauser et al., 2005).
6 months after delivery (18 months after IIP)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Volumetric analysis of buccal contour to assess changes in buccal countour
Time Frame: Before surgery - 3 months - 6 months - 9 months - 12 months
Measured with Extra oral scanning + 3D viewer software
Before surgery - 3 months - 6 months - 9 months - 12 months
Bucco-palatal width
Time Frame: Before surgery - 12 months
Measured with CBCT
Before surgery - 12 months
Gingival thickness
Time Frame: Before surgery - 6 months - 12 months
Measured with periodontal probe
Before surgery - 6 months - 12 months
Mid facial recession to assess the changes in tissue level
Time Frame: Before surgery - 3 months - 6 months - 9 months - 12 months
Measured with 3D Viewer software
Before surgery - 3 months - 6 months - 9 months - 12 months
Interdental papillae height to assess changes in papilla height
Time Frame: Before surgery - 3 months - 6 months - 9 months - 12 months
Measured with 3D Viewer software
Before surgery - 3 months - 6 months - 9 months - 12 months
Modified Plaque Index
Time Frame: 3 months - 6 months - 9 months - 12 months
Measured with Periodontal probe
3 months - 6 months - 9 months - 12 months
Modified Bleeding Index
Time Frame: 3 months - 6 months - 9 months - 12 months
Measured with Periodontal probe
3 months - 6 months - 9 months - 12 months
Patient satisfaction
Time Frame: 12 months
Measured with Visual Analogue Scale (VAS). The patients will mark their satisfaction in a non-numerical 100 mm line ranging from "not at all satisfied=0" (left) to "very satisfied=100" (right), for each implant
12 months

Collaborators and Investigators

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

Sponsor

Misr International University

Investigators

  • Principal Investigator: Ahmed I Abo El Futtouh, Master, Clinical Director of Implant Program - Misr International University
  • Study Chair: Nael A Mina, Bsc, Misr International University
  • Study Chair: Abdel Rahman A Abdel Rahman, Master, IDCE
  • Study Chair: Ahmed F Mostafa, Bsc, IDCE
  • Study Director: Khaled Abdel-Ghaffar, Professor, Minister of Higher Education and Scientific Research
  • Study Director: Inas S Hanna, Bsc, Dentist/Researcher - IDCE

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

July 1, 2020

Primary Completion (Actual)

February 1, 2023

Study Completion (Actual)

February 1, 2023

Study Registration Dates

First Submitted

March 9, 2020

First Submitted That Met QC Criteria

March 13, 2020

First Posted (Actual)

March 17, 2020

Study Record Updates

Last Update Posted (Actual)

November 21, 2024

Last Update Submitted That Met QC Criteria

November 19, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PER8273002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All data can be shared

IPD Sharing Time Frame

One year

IPD Sharing Access Criteria

Principal investigator

IPD Sharing Supporting Information Type

  • SAP
  • CSR

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

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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