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OpenTrials
Completed

NCT Number: NCT02543398

Evaluation of Healing at Molar Extraction Sites With and Without Ridge Preservation

Following tooth extraction ridge preservation procedure have been suggested to limit bone resorptive dimensional changes to facilitate prospective implant placement. While this is particularly true for anterior teeth, no evidence is available to establish clinical guidelines in posterior sites, i.e. following molar extraction.

This research project will answer the following question:

What are the dimensional changes of the hard and soft tissues encountered following molar extractions with and without ridge preservation?

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients will be included in this study if they qualify the following inclusion criteria:
  • One molar tooth that has been identified by dental faculty as requiring a single tooth extraction
  • A dental implant is indicated and treatment planned to replace the missing molar tooth
  • Have adequate restorative space for a dental implant-retained restoration
  • Have at least 10mm of alveolar bone height, without impinging on the maxillary sinus or inferior alveolar canal.

Exclusion criteria

  • Obvious exclusions are patients who do not meet all the inclusion criteria or who will not cooperate with the follow-up schedule.
  • Patients will not be entered who are mentally incompetent, prisoners, or pregnant.
  • Pregnant women or women intending to become pregnant during the study period. As standard practice prior to dental surgery, females of child-bearing age are asked verbally if there is any possibility that they are pregnant. If not, we proceed with surgery and no pregnancy test is done. If the woman states that there is a possibility that she is pregnant, we do a urine pregnancy test to rule pregnancy in or out. So use of the urine pregnancy test is only done if she says she may be pregnant. [If needed: An over-the-counter urine pregnancy test will be provided to female subjects in the graduate periodontics clinic of UTHSCSA. Patients will be allowed access to a private restroom and the results of the tests will be read by one of the named investigators. Only those with a negative pre-operative pregnancy test will be eligible for the study.] Female patients who have undergone a hysterectomy, tubal ligation or menopause will be excluded from pregnancy testing.
  • Patients who become pregnant during the study will be withdrawn and standard care will be delivered.
  • Clinical and/or radiographic determinations which will preclude inclusion in this study are:
  • Active localized or systemic infection other than periodontitis.
  • Untreated periodontal diseases
  • Inadequate bone dimensions or restorative space dimensions to place a dental implant
  • Presence of a disease entity, medical condition or therapeutic regimen which decreases probability of soft tissue and bony healing, e.g., poorly controlled diabetes, chemotherapeutic and immunosuppressive agents, or autoimmune diseases.
  • Positive medical history of endocarditis following oral or dental surgery.

Treatment and study plan

Ridge Preservation

Procedure

Ridge preservation is a procedure which consists in grafting the tooth extraction socket with a bone grafting material and cover the site with a membrane to protect the site.

Primary outcomes

  1. Radiographic Bone Changes

    Time frame: 3 months after tooth extraction

    The width and the height of the alveolar ridge will be measured (in mm) on the initial (i.e. following tooth extraction) Cone Beam CT and on the CBCT taken prior to implant placement (i.e. 3 months after tooth extraction)

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Collaborators

  • Osteogenics Biomedical

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Sep 7, 2015
Registry last updated
Jun 28, 2018

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.

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