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Effect of Locally Applied Hyaluronic Acid, Mixed With Autogenous Demineralized Tooth Graft, for Socket Preservation, Versus Autogenous De-mineralized Tooth Graft.

Primary Purpose

Alveolar Bone Resorption, Socket Preservation, Bone Resorption

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
tooth extraction and socket preservation with demineralized tooth graft
tooth extraction and socket preservation with demineralized tooth graft with hyaluronic acid
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alveolar Bone Resorption

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 1. 18 years old or older. 2. Requiring alveolar preservation after tooth extraction prior to placement of dental implant. 3. Participants that are eligible for immediate implantation, yet having factors that are hindering these patients from immediate placement of an implant at the time of extraction (ex: Financial related factors - psychological factors - time related factors). 4. Motivated patients with good enough understanding of oral health measurements and importance. 5. Sufficient keratinized gingiva to cover the grafted bone. 6. The presence of dentition adjacent to the bone defect. 7. Patients who are healthy or have well-controlled systemic disease(s). 8. Teeth extractions are to be recommended due to trauma, caries, or periodontal diseases. * 9. Single rooted teeth from both arches. 10. No acute infections, pus formation, socket and bony discharges. 11. Hopeless teeth, to be extracted, are bounded both mesially and distally by adjacent, teeth. 12. Intact buccal bone of the teeth to be extracted. Exclusion Criteria: 1. Heavy smokers (more than 10 cigarettes per day or an electronic cigarette dose of >6 mg/ml of nicotine). 2. Presence of active infection or severe inflammation in the intervention zone. 3. Relevant medical history that contraindicates implant surgery. 4. Immunosuppression (eg. Hiv, solid-organ transplants). 5. Head and neck-irradiated patients in the past 5 years. 6. Regular intake of bisphosphonates, anticoagulants, or anti-inflammatories. 7. Chronic drug abuse or alcoholic habits. 8. Patients with poor oral hygiene (full-mouth plaque score and full-mouth bleeding score >15%) and lack of motivation. 9. Uncontrolled diabetes (reported levels of glycated haemoglobin exceeding 7%). 10. Uncontrolled and /or untreated periodontal disease. 11. Patients who had previously received bone graft on the site to be operated. 12. Patients with significant comorbidity such as recent heart attack or coagulation disorder. 13. Pregnant subjects.

Sites / Locations

  • Cairo universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

tooth extraction and socket preservation with demineralized tooth graft

tooth extraction and socket preservation with demineralized tooth graft and hyaluronic acid

Arm Description

Outcomes

Primary Outcome Measures

(BLRW)
Bucco-lingual alveolar ridge width
(BRH)
Height of Buccal ridge
(LRH).
height of Lingual ridge

Secondary Outcome Measures

Percentage of newly formed bone
soft tissue healing
percentage of complete post operative wound closure by soft tissues
residual graft
percentage of residual bone graft particles
Visual analogue score (VAS)
Patient's pain and discomfort, 0-10 score, 0 represents "no pain", 10 represents "as bad as possible"

Full Information

First Posted
November 4, 2022
Last Updated
March 6, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05613075
Brief Title
Effect of Locally Applied Hyaluronic Acid, Mixed With Autogenous Demineralized Tooth Graft, for Socket Preservation, Versus Autogenous De-mineralized Tooth Graft.
Official Title
Potential Effect Assessment of Locally Applied Hyaluronic Acid, When Mixed With Autogenous De-mineralized Tooth Graft, for Socket Preservation, in Comparison With the Application of Autogenous De-mineralized Tooth Graft Alone.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
June 15, 2023 (Anticipated)
Study Completion Date
September 29, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Many dentists, clinicians and researchers have conducted numerous trials, and put several materials and procedures under the test, in an attempt to preserve vertical and/or horizontal extraction sockets dimensions. The clinical consequences of post-extraction remodeling may affect the outcome of the ensuing therapies aimed at restoring the lost dentition, either by limiting the bone availability for ideal implant placement or by compromising the aesthetic result of the prosthetic restorations. In an attempt for ridge/socket preservation of a freshly extracted tooth socket/bed, this study aims to assess and compare between using autogenous tooth graft added with Hyaluronic acid, and the usage of the standardized autogenous tooth graft alone, regarding the potency, preservative feature, and quality of bone healing, density, and deposition. For a better restorative outcome using a delayed implant placement later on in the edentulous area.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Bone Resorption, Socket Preservation, Bone Resorption

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
tooth extraction and socket preservation with demineralized tooth graft
Arm Type
Active Comparator
Arm Title
tooth extraction and socket preservation with demineralized tooth graft and hyaluronic acid
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
tooth extraction and socket preservation with demineralized tooth graft
Intervention Description
tooth extraction and socket preservation with demineralized tooth graft
Intervention Type
Procedure
Intervention Name(s)
tooth extraction and socket preservation with demineralized tooth graft with hyaluronic acid
Intervention Description
tooth extraction and socket preservation with demineralized tooth graft with hyaluronic acid
Primary Outcome Measure Information:
Title
(BLRW)
Description
Bucco-lingual alveolar ridge width
Time Frame
6 months
Title
(BRH)
Description
Height of Buccal ridge
Time Frame
6 months
Title
(LRH).
Description
height of Lingual ridge
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Percentage of newly formed bone
Time Frame
6 months
Title
soft tissue healing
Description
percentage of complete post operative wound closure by soft tissues
Time Frame
2 weeks
Title
residual graft
Description
percentage of residual bone graft particles
Time Frame
6 months
Title
Visual analogue score (VAS)
Description
Patient's pain and discomfort, 0-10 score, 0 represents "no pain", 10 represents "as bad as possible"
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 1. 18 years old or older. 2. Requiring alveolar preservation after tooth extraction prior to placement of dental implant. 3. Participants that are eligible for immediate implantation, yet having factors that are hindering these patients from immediate placement of an implant at the time of extraction (ex: Financial related factors - psychological factors - time related factors). 4. Motivated patients with good enough understanding of oral health measurements and importance. 5. Sufficient keratinized gingiva to cover the grafted bone. 6. The presence of dentition adjacent to the bone defect. 7. Patients who are healthy or have well-controlled systemic disease(s). 8. Teeth extractions are to be recommended due to trauma, caries, or periodontal diseases. * 9. Single rooted teeth from both arches. 10. No acute infections, pus formation, socket and bony discharges. 11. Hopeless teeth, to be extracted, are bounded both mesially and distally by adjacent, teeth. 12. Intact buccal bone of the teeth to be extracted. Exclusion Criteria: 1. Heavy smokers (more than 10 cigarettes per day or an electronic cigarette dose of >6 mg/ml of nicotine). 2. Presence of active infection or severe inflammation in the intervention zone. 3. Relevant medical history that contraindicates implant surgery. 4. Immunosuppression (eg. Hiv, solid-organ transplants). 5. Head and neck-irradiated patients in the past 5 years. 6. Regular intake of bisphosphonates, anticoagulants, or anti-inflammatories. 7. Chronic drug abuse or alcoholic habits. 8. Patients with poor oral hygiene (full-mouth plaque score and full-mouth bleeding score >15%) and lack of motivation. 9. Uncontrolled diabetes (reported levels of glycated haemoglobin exceeding 7%). 10. Uncontrolled and /or untreated periodontal disease. 11. Patients who had previously received bone graft on the site to be operated. 12. Patients with significant comorbidity such as recent heart attack or coagulation disorder. 13. Pregnant subjects.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rahma H Mohamed Ali
Phone
01065800517
Ext
+20
Email
rahma.ahmed@dentistry.cu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rahma H Mohamed Ali
Organizational Affiliation
Cairo University, Faculty of Dentistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo university
City
Cairo
ZIP/Postal Code
12611
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rahma H Mohamed Ali, B.D.S
Phone
23634965
Ext
+202
Email
rec@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name & Degree
Rahma H Mohamed Ali, B.D,S

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Effect of Locally Applied Hyaluronic Acid, Mixed With Autogenous Demineralized Tooth Graft, for Socket Preservation, Versus Autogenous De-mineralized Tooth Graft.

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