Evaluation of Hyaluronic Acid in Addition to Xenograft in Immediate Implant Placement Within Maxillary Esthetic Zone

January 14, 2025 updated by: Rabia Mohamad Dakhil, Mansoura University

Evaluation of Hyaluronic Acid in Addition to Xenograft Material in Treatment Peri-implant Bony Defects in Immediate Implant Placement Within Maxillary Esthetic Zone

Study design:

The present study will be carried out on twenty patients selected from the department of Oral Medicine, Periodontology, Oral Diagnosis and Radiology, Faculty of Dentistry, Mansoura University for replacement of non restorable maxillary anterior and/or premolar teeth within esthetic zone by immediate implant divided into two groups. A written informed consent will be obtained from all patients before their participation in this study.

Evaluation of study:

All patients will be seen at regular time interval for evaluation at the visit of surgical intervention , follow up of clinical parameter will be recorded monthly then three , six months postoperative and six month after loading(with twelve month follow up study).

  1. Clinical evaluation:

    Implant stability evaluation Soft tissue evaluation

  2. Radiographic evaluation:

    • Marginal bone loss(MBL).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Study design:

The present study will be carried out on two groups of patients.

A-Patients Sample:

Twenty patients selected from the department of Oral Medicine, Periodontology, Oral Diagnosis and Radiology, Faculty of Dentistry, Mansoura University for replacement of non restorable maxillary anterior and/or premolar teeth within esthetic zone by immediate implant. A written informed consent will be obtained from all patients before their participation in this study.

i. Group (1): Comprised of ten patients with hopeless non-restorable maxillary anterior and/or premolar tooth within the esthetic zone will be extracted and replaced by an immediately placed dental implant in conjunction with Bovine bone mineral graft material( cerabone®,Botiss biomaterial) followed by healing abutment.

ii. Group (2): Comprised of ten patients with hopeless non-restorable maxillary anterior and/or premolar tooth within the esthetic zone will be extracted and replaced by an immediately placed dental implant in conjunction with Bovine bone mineral with sodium hyaluronate graft material (cerabone®plus,Botiss biomaterial) followed by healing abutment.

Inclusion criteria:

• Patients who are medically free from any systemic diseases.

• Patients with good oral hygiene and regular maintenance.

  • Age of patients will be >20 years.
  • Presence of at least single non restorable maxillary anterior and/or premolar tooth due to caries, root resorption, endodontic failure, root fracture or tooth with open apex.
  • No acute infection is present within both periodontal and/or peri-apical area within the tooth of concern and/or adjacent teeth.
  • Patients with extraction socket type I.
  • Free from history of clenching, tapping and bruxism.
  • Patients prepared to co-operate and comply with the follow-up and maintenance program.

Exclusion criteria:

• Patients taking medications known to influence bone metabolism ( such as heparin, warfarin, corticosteroid).

• Smoking and alcoholic patients.

  • History of radiation in the head and neck region.
  • Insufficient interocclusal distance for implant placement and restoration.
  • Patient with lack of stable posterior occlusion.
  • Pregnant, lactating and post-menopausal female patients. Complete medical history, dental history will be taken to all of patients in the study.

Materials:

A. Dental Implants: Conventional 2 pieces screw type dental implants. B. Bone substitute: Bovine bone graft material (cerabone®,Botiss biomaterial) and Bovine bone substitute with sodium hyaluronate graft material (cerabone®plus,Botiss biomaterial).

C. Trephine bur: to create intentional bony defect in experimental rabbits. D. Ostell: to measure the primary and secondary stability of the implant.

Methods:

  1. Pre-operative measurements:

    A. Photographs: for all items under research. B. Preoperative Radiographs: CBCT will be taken for clinical patients before treatment.

    C. Antibiotic administration for both patients and rabbits before implant placement.

  2. Surgical Procedures:

1. Clinical sample (patients) :

• Atraumatic removal of remaining root or tooth will be performed using periotome, appropriate forceps and elevators in an attempt to preserve the buccal plate of bone and soft tissue.

• Implant will be placed in fresh socket using implant motor with saline coolant after curettage and its size is determined according to pre-operative CBCT within both groups.

  • Group (1): Bovine bone graft (cerabone®,Botiss biomaterial)will be added to the implant.
  • Group (2): Bovine bone substitute with sodium hyaluronate graft (cerabone®plus,Botiss biomaterial) will be added to the implant.
  • followed by healing abutment.
  • Post-operative care: The patients will be instructed to consume soft food for eight weeks Patients will be maintained on amoxicillin twice a day for six days and Ibuprofen 400mg 2 to 4 times daily

  • loading will begin at three to four months from surgical intervention.

    3-Evaluation of study:

A. Patients evaluation:

All patients will be seen at regular time interval for evaluation at the visit of surgical intervention , follow up of clinical parameter will be recorded monthly then three , six months postoperative and six month after loading(with twelve month follow up study).

  1. Clinical evaluation:

    i. Soft tissue evaluation: This will be done in both groups where, soft tissue evaluation will be done using probing depth(PD) and pink esthetic score (PES) around dental implant.

    ii. Implant stability evaluation: Using Osstell implant stability will be assessed in both groups soon after implant placement to assess primary implant stability then three , six and twelve months after surgery to assess secondary implant stability.

  2. Radiographic evaluation:

    Radiographic assessment will be held preoperative ,six and twelve months after implant placement for evaluation of:

    • Marginal bone loss(MBL).

    Statistical Analysis:

    All data will be collected and statistically analyzed.

Study Type

Interventional

Enrollment (Actual)

20

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
    • Mansora
      • Egypt, Mansora, Egypt, 35516
        • Mansoura University

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:

  • • Patients who are medically free from any systemic diseases.

    • Patients with good oral hygiene and regular maintenance.
    • Age of patients will be >20 years.
    • Presence of at least single non restorable maxillary anterior and/or premolar tooth due to caries, root resorption, endodontic failure, root fracture or tooth with open apex.
    • No acute infection is present within both periodontal and/or peri-apical area within the tooth of concern and/or adjacent teeth.
    • Patients with extraction socket type I.
    • Free from history of clenching, tapping and bruxism.
    • Patients prepared to co-operate and comply with the follow-up and maintenance program.

Exclusion Criteria:

  • • Patients taking medications known to influence bone metabolism ( such as heparin, warfarin, corticosteroid).

    • Smoking and alcoholic patients.
    • History of radiation in the head and neck region.
    • Insufficient interocclusal distance for implant placement and restoration.
    • Patient with lack of stable posterior occlusion.
    • Pregnant, lactating and post-menopausal female patients. Complete medical history, dental history will be taken to all of patients in the study.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: immediate dental implant with cerabone®
Comprised of ten patients with hopeless non-restorable maxillary anterior and/or premolar tooth within the esthetic zone will be extracted and replaced by an immediately placed dental implant in conjunction with Bovine bone mineral graft material( cerabone®,Botiss biomaterial) followed by healing abutment.
Procedure: cerabone
Atraumatic removal of remaining root or tooth will be performed Implant will be placed in fresh socket Bovine bone graft (cerabone®,Botiss biomaterial) will be added to the implant
Active Comparator: immediate dental implant with cerabone plus®
Comprised of ten patients with hopeless non-restorable maxillary anterior and/or premolar tooth within the esthetic zone will be extracted and replaced by an immediately placed dental implant in conjunction with Bovine bone mineral with sodium hyaluronate graft material (cerabone®plus,Botiss biomaterial) followed by healing abutment.
Procedure: cerabone®plus
Atraumatic removal of remaining root or tooth will be performed Implant will be placed in fresh socket Bovine bone substitute with sodium hyaluronate graft (cerabone®plus,Botiss biomaterial) will be added to the implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
radiographic marginal bone change
Time Frame: preoperative , at time implant placement, six and twelve months after implant placement
Radiographic cone beam tomography (CBCT) assessment will be held preoperative ,at time implant placement, six and twelve months after implant placement
preoperative , at time implant placement, six and twelve months after implant placement
Implant stability evaluation
Time Frame: at time of placement, three , six months after surgery to assess secondary implant stability
Using Osstell implant stability will be assessed in both groups soon after implant placement to assess primary implant stability then three , six months after surgery to assess secondary implant stability
at time of placement, three , six months after surgery to assess secondary implant stability

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Soft tissue evaluation
Time Frame: monthly then three , six months postoperative and six month after loading
This will be done in both groups where, soft tissue evaluation will be done using probing depth(PD) and pink esthetic score (PES) around dental implant
monthly then three , six months postoperative and six month after loading

Collaborators and Investigators

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

Sponsor

Mansoura University

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)

October 30, 2023

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

May 30, 2025

Study Registration Dates

First Submitted

January 9, 2025

First Submitted That Met QC Criteria

January 14, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 14, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • A0104023OM

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

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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