Post Extraction Wound Healing Evaluation of Immediate Complete Denture Using IPR Scale
Primary Purpose
Complete Edentulism Due to Periodontal Disease (Disorder)
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CEO Pack
Sponsored by
About this trial
This is an interventional treatment trial for Complete Edentulism Due to Periodontal Disease (Disorder)
Eligibility Criteria
Inclusion Criteria:
- Good physical and mental health
- Willing to give informed consent
- Normal maxilla-mandibular relationship Angle Class I
- Adequate bone quality and quantity in terms of width and height in the anterior maxillary and mandibular ridges verified by preoperative cone beam CT
- Adequate inter-arch space to accommodate maxillary and mandibular implant prostheses
Exclusion Criteria:
- Uncontrolled diabetes
- Smoking habits
- Radiotherapy
- Clinical or radiographic signs of pathologic conditions, osteoporosis
- Patients on corticosteroids
- Bruxism
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Conventional upper immediate denture
Upper immediate denture lined by surgical dressing
Arm Description
Conventional upper immediate denture without any surgical lining
Upper immediate denture lined by surgical dressing using CEO Pack dressing
Outcomes
Primary Outcome Measures
Post extraction Assessment
Post extraction Assessment of Wound Healing following Inflammatory Proliferative Remodeling (IPR) scale. The scale is divided into three subscales corresponding to the three phases of wound healing, and each is rated at the appropriate time point during follow-up,3 yielding three subscale scores and a total score. The outcome parameters of the subscales depend on the biological events that occur during that specific phase. At the end of follow up, the total score of the IPR Scale was calculated (0-16), where 0-4 indicated poor healing, 5-10 acceptable healing, and 11-16 excellent healing
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05464914
Brief Title
Post Extraction Wound Healing Evaluation of Immediate Complete Denture Using IPR Scale
Official Title
Post Extraction Wound Healing Evaluation of Immediate Complete Denture Using IPR Scale
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2023 (Anticipated)
Primary Completion Date
February 1, 2023 (Anticipated)
Study Completion Date
April 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Badr University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
In the first part, after a brief introduction, the advantages and disadvantages of immediate dentures are compared. There is a detailed discussion on assessment and treatment planning which includes history taking, examination of the soft and hard tissues, current prostheses, occlusion as well as discussion on investigations required and formulating a diagnosis. The first part ends with a summary of types of immediate dentures and denture designs.
Detailed Description
An Immediate denture is a complete or partial removable prosthesis that is fitted immediately after extraction or modification of teeth. The prosthesis replaces the missing/modified teeth and where required, the adjacent hard and soft tissues. It is constructed prior to the extraction of teeth and is used immediately to provide function and aesthetics which are lost as a result of tooth removal and avoid the embarrassment patients may have with living without teeth, while waiting for the tissues to heal prior to definitive tooth replacement.1 (See image 1) Some clinicians take impressions on the day of the extractions and fit the dentures a few days later. These dentures are fraught with challenges as the alveolar ridge begins to resorb soon after. Therefore an immediate denture is only truly an immediate denture when fitted on the day of the extractions.
The use of a removable prosthesis within the UK is currently around 19% of adults in the general population 2 and in spite of this decreasing trend, as patients retain their natural dentition into older age,2 there is still a need for prosthodontic replacement as teeth are lost as a result of caries, periodontal disease, tooth wear or trauma. 3,4,5 The provision of an immediate denture can be challenging and close co-operation between patient, technician, and clinician is required.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complete Edentulism Due to Periodontal Disease (Disorder)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Conventional upper immediate denture
Arm Type
No Intervention
Arm Description
Conventional upper immediate denture without any surgical lining
Arm Title
Upper immediate denture lined by surgical dressing
Arm Type
Active Comparator
Arm Description
Upper immediate denture lined by surgical dressing using CEO Pack dressing
Intervention Type
Drug
Intervention Name(s)
CEO Pack
Other Intervention Name(s)
Perio pak, Surgical pak
Intervention Description
is a eugenol-free, surgical dressing and periodontal pack that has no burning sensation, no unpleasant taste or odor, and offers proven protection to surgical sites. This product promotes cleanliness and healing. Plastic and cohesive, ropes of any length or thickness can be formed. The smooth texture allows this product to adapt closely to the teeth and tissue in order to protect the wound. It sets with resilient, non-brittle hardness.
Primary Outcome Measure Information:
Title
Post extraction Assessment
Description
Post extraction Assessment of Wound Healing following Inflammatory Proliferative Remodeling (IPR) scale. The scale is divided into three subscales corresponding to the three phases of wound healing, and each is rated at the appropriate time point during follow-up,3 yielding three subscale scores and a total score. The outcome parameters of the subscales depend on the biological events that occur during that specific phase. At the end of follow up, the total score of the IPR Scale was calculated (0-16), where 0-4 indicated poor healing, 5-10 acceptable healing, and 11-16 excellent healing
Time Frame
6 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Good physical and mental health
Willing to give informed consent
Normal maxilla-mandibular relationship Angle Class I
Adequate bone quality and quantity in terms of width and height in the anterior maxillary and mandibular ridges verified by preoperative cone beam CT
Adequate inter-arch space to accommodate maxillary and mandibular implant prostheses
Exclusion Criteria:
Uncontrolled diabetes
Smoking habits
Radiotherapy
Clinical or radiographic signs of pathologic conditions, osteoporosis
Patients on corticosteroids
Bruxism
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shady M. El Naggar, PhD
Phone
01122110085
Email
shady.mahmoud@buc.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shady M. El Naggar, PhD
Organizational Affiliation
Badr University in Cairo
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Post Extraction Wound Healing Evaluation of Immediate Complete Denture Using IPR Scale
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