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Clinical Trials/NCT05464914
NCT05464914CompletedNot Applicable

Post Extraction Wound Healing Evaluation of Immediate Complete Denture Using IPR Scale

Badr University1 site in 1 country12 target enrollmentStarted: August 1, 2024Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
12
Locations
1
Primary Endpoint
Post extraction Assessment

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
40 Years to 75 Years (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Upper immediate denture lined by surgical dressing

Active Comparator

Upper immediate denture lined by surgical dressing using CEO Pack dressing

Intervention: CEO Pack (Drug)

Outcomes

Primary Outcomes

Post extraction Assessment

Time Frame: 6 weeks

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 Outcomes

No secondary outcomes reported

Investigators

Sponsor
Badr University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Shady El Naggar

Clinical Professor

Badr University

Study Sites (1)

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