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Completed

NCT Number: NCT05464914

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

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.

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Key information

Age range

40 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Shady Elnaggar

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CEO Pack

Drug

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.

Other names: Perio pak, Surgical pak

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Badr University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 19, 2022
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.