Buccal Soft Tissue Contour Changes After Immediate Implant Placement with or Without Connective Tissue Graft

October 15, 2024 updated by: Ahmed Abo El Futtouh, Misr International University

Volumetric Evaluation of Buccal Soft Tissue Contour Using Customized Healing Abutment During Immediate Implant Placement with Connective Tissue Grafting. a Randomized Controlled Clinical Trial

Statement of the problem: Using customized contoured healing abutments at the time of immediate implant placement is a treatment modality to improve esthetics by maintain the soft tissue contour. Using connective tissue grafts enhances and maintains soft tissue stability. However, the effect of the combined procedures for maintenance of the soft tissue morphology remains unclear. Purpose : The aim of the study is to evaluate the volumetric difference of buccal soft tissue contour around immediate implants placed with and without connective tissue grafts and customized healing abutments. Materials and Methods: Fifty-two patients with single maxillary anterior or premolar tooth indicated for extraction will participate in this study, 13 patients will randomly be assigned in each group. Group 1 (test group) will be treated by immediate implant placement (IIP) with connective tissue graft (CTG) and customized healing abutment, Group 2 (test group) IIP with CTG and healing abutment same diameter of the implant, Group 3 (test group) IIP and customized healing abutment, while the 4th group (control) IIP with healing abutment same diameter of the implant. Extra-oral scanning of the buccal contour will be carried out presurgical and at 3, 6, 9 and 12 months after surgery. Difference in contour gained will be compared to the original contour and between groups. Radiographic evaluation will be done using CBCT at 12 months to measure the bone width. In addition, soft tissue thickness, mid facial recession, gingival biotype, interdental papilla height, soft tissue peri- implant parameters and any surgical or prosthetic complications will be assessed.

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. 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 (31). After implant placement, the allocation will be revealed to the practitioner for the type of the healing abutment to be used and whether connective tissue graft will be used or not.

Thirteen implants (intervention 1) will receive screw- retained customized healing abutment, and thirteen other implants in the 2nd intervention group will receive the conventional healing abutment of same diameter of the implant. In both groups connective tissue graft will be used. 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.

The fabrication of the customized healing abutment is as follows; the temporary cylindrical abutment will be screwed to the implant then flowable composite will be injected at the gingival margin level to adapt to the screw-retained temporary cylindrical abutments that will be sand-blasted for mechanical retention of the composite, taking the shape of the socket at the marginal gingiva. 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. Patients will be recalled for regular follow ups. Other thirteen implants (intervention 3) will receive screw- retained customized healing abutment, and for the control (the 4th group) group thirteen implants will receive the conventional healing abutment of same diameter of the implant. No connective tissue grafts are to be used in these two groups.

Study Type

Interventional

Enrollment (Actual)

52

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. Adults at or above the age of 18.
  2. Patients who have at least one non-restorable maxillary anterior or premolar tooth with sound adjacent teeth.
  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(24).
  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) (25)
  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: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CTG and customized healing abutment
Customized healing abutment used with connective tissue graft
Procedure: CTG and customized healing abutment
screw- retained customized healing abutment
Other Names:
  • zimmer biomed dental implants and connective tissue grafts and customized healing abutments
Experimental: CTG and conventional healing abutment
Conventional healing abutment (same diameter of the implant) used with connective tissue graft
Procedure: CTG and conventional healing abutment
conventional healing abutment
Other Names:
  • Zimmer biomed dental implants and connective tissue graft
Active Comparator: customized healing abutment
Customized healing abutment used without connective tissue graft
Procedure: CTG and customized healing abutment
screw- retained customized healing abutment
Other Names:
  • zimmer biomed dental implants and connective tissue grafts and customized healing abutments
Active Comparator: conventional healing abutment
Conventional healing abutment (same diameter of the implant) without connective tissue graft
Procedure: CTG and conventional healing abutment
conventional healing abutment
Other Names:
  • Zimmer biomed dental implants and connective tissue graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Volumetric analysis of buccal contour
Time Frame: Before surgery - 3 months - 6 months - 9 months - 12 months
Measuring 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. This will be done using Extra oral scanning and 3D viewer software
Before surgery - 3 months - 6 months - 9 months - 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bucco-palatal width
Time Frame: Before surgery - 12 months
Measured using Cone Beam CT
Before surgery - 12 months
Gingival thickness
Time Frame: Before surgery - 6 months - 12 months
Measured using Periodontal Probe
Before surgery - 6 months - 12 months
Mid facial recession
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
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 Director: Khaled Abdel-Ghaffar, Doctor, Minister of Higher Education and Scientific Research
  • Study Director: Inas M El-Zayat, Doctor, Assoc.Prof - Operative department, Faculty of Dentistry
  • Study Director: Mariam S Hanna, Bsc, Dentist/Researcher - IDCE
  • 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

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)

August 1, 2024

Study Completion (Actual)

August 1, 2024

Study Registration Dates

First Submitted

March 9, 2020

First Submitted That Met QC Criteria

March 13, 2020

First Posted (Actual)

March 16, 2020

Study Record Updates

Last Update Posted (Actual)

October 17, 2024

Last Update Submitted That Met QC Criteria

October 15, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PER8273003

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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