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

Not Applicable

Active, not recruiting

• Conditions: Effect of Putty Form Bone Graft in Immediate Implant Placment

• Registration Number: NCT06783517
• Lead Sponsor: Mansoura University

Brief Summary

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).

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 Timeline

• Study Start: 2023-10-30
• Status Verified: 2025-01
• Study First Submitted: 2025-01-09
• Study First Submitted QC: 2025-01-14
• Last Update Submitted: 2025-01-14
• Study First Posted: 2025-01-20
• Last Update Posted: 2025-01-20
• Primary Completion: 2025-03-01
• Study Completion: 2025-05-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
radiographic marginal bone change	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
Implant stability evaluation	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

Secondary Outcome Measures

Name	Time	Method
Soft tissue evaluation	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

Trial Locations

Locations (1)

Mansoura university; 🇪🇬 Egypt, Mansora, Egypt