- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06624982
Determinants of Bone Dimensional Changes After Extraction and Alveolar Ridge Preservation
Study Overview
Status
Intervention / Treatment
Detailed Description
The null hypothesis for this study is that there is no difference in bone ridge width and height changes 4 months following extraction and alveolar ridge preservation at sites that undergo immediate post-extraction socket expansion or no immediate post-extraction ridge width change. Patients of the Graduate Periodontics Clinic at Marquette University School of Dentistry scheduled for extraction, bone graft and resorbable membrane will be recruited for this study.
After providing informed consent and prior to local anesthesia and extraction, the following parameters will be recorded: age, gender, race, medical history, medications, tooth site, reason for extraction and tooth mobility. Gingival width will be recorded prior to local anesthesia and extraction, and at 4 months. Gingival thickness will be recorded after local anesthesia and prior to extraction, and at 4 months. Buccolingual ridge width and ridge height will be recorded immediately before, immediately after extraction, and at 4 months. Immediately after extraction, the following measurements will be recorded: buccal bone thickness, number of roots, root length and width, instruments used for extraction, need for flap elevation, duration of extraction, anesthetic amount, type and approach, and operator experience.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Vrisiis Kofina, DDS, MS
- Phone Number: 4142886521
- Email: vrisiis.kofina@marquette.edu
Study Contact Backup
- Name: Samah Rady, DDS
- Phone Number: 9497962173
- Email: samahsy.rady@marquette.edu
Study Locations
-
-
Wisconsin
-
Milwaukee, Wisconsin, United States, 53233
- Recruiting
- Marquette University School of Dentistry Graduate Periodontics Clinic
-
Contact:
- Vrisiis Kofina, DDS, MS
- Phone Number: 4142886521
- Email: vrisiis.kofina@marquette.edu
-
Contact:
- Arndt Guentsch, DMD, PhD, MHBA, MS
- Phone Number: 4142886089
- Email: arndt.guentsch@marquette.edu
-
Principal Investigator:
- Vrisiis Kofina, DDS, MS
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult patients (18-75 years)
- Good general health (controlled conditions)
- Controlled periodontal disease
- Scheduled for single tooth extraction with bone graft placement and resorbable membrane
- Tooth to be extracted must have adjacent teeth
- Socket wall integrity
Exclusion Criteria:
- Smoking
- Pregnancy
- Active periodontal disease
- Systemic conditions that affect healing
- Lack of socket wall integrity (bone loss ≥50 %) prior to extraction, teeth with severe infection requiring pre-extraction antibiotic treatment to control infection), and contraindications for tooth extraction.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Non-molar sites with immediate post-extraction ridge expansion
Non-molar sites with an increase of buccolingual bone width immediately after tooth extraction compared to pre-extraction.
|
Observational study; alveolar ridge preservation
|
|
Non-molar sites with no immediate post-extraction ridge width change
Non-molar sites without a change in buccolingual bone width immediately after tooth extraction compared to pre-extraction.
|
Observational study; alveolar ridge preservation
|
|
Molar sites with immediate post-extraction ridge expansion
Molar sites with an increase of buccolingual bone width immediately after tooth extraction compared to pre-extraction.
|
Observational study; alveolar ridge preservation
|
|
Molar sites with no immediate post-extraction ridge width change
Molar sites without a change in buccolingual bone width immediately after tooth extraction compared to pre-extraction.
|
Observational study; alveolar ridge preservation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Buccolingual ridge width
Time Frame: (1) After local anesthesia and before extraction, (2) immediately after extraction and (3) 4 months after extraction and alveolar ridge preservation
|
Buccolingual ridge width will be measured through a stent via ridge mapping calipers.
The measurement locations will be at 1mm, 3mm and 5mm from the midbuccal crest.
The same measurements will be recorded at all selected time points.
|
(1) After local anesthesia and before extraction, (2) immediately after extraction and (3) 4 months after extraction and alveolar ridge preservation
|
|
Ridge height
Time Frame: (1) After local anesthesia and before extraction, (2) immediately after extraction and (3) 4 months after extraction and alveolar ridge preservation
|
Ridge height will be measured through a stent via a periodontal probe as the distance between bone and predetermined landmarks on the stent.
The measurement locations will be mesial buccal, midbuccal, distal buccal, mesial lingual, midlingual and distal lingual.
The same measurements will be recorded at all selected time points.
|
(1) After local anesthesia and before extraction, (2) immediately after extraction and (3) 4 months after extraction and alveolar ridge preservation
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Vrisiis Kofina, DDS, MS, Marquette University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HR-4787
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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