Clinical trial NCT06624982: Determinants of Bone Dimensional Changes After Extraction and Alveolar Ridge Preservation
Official title: Determinants of Bone Dimensional Changes After Extraction and Alveolar Ridge Preservation
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Alveolar Bone Grafting
Bone Healing
Tooth Extraction Site Healing
Wound Healing
Lead sponsor: Marquette University
Sponsor class: OTHER
First posted: 2024-10-03
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for tooth extraction and alveolar ridge preservation (bone graft and membrane) in the Graduate Periodontics Clinic at Marquette University School of Dentistry.

Brief summary: The main purpose of the study is to measure and localize immediate post extraction changes i.e. socket expansion versus no width change along the socket wall and identify whether the immediate post-extraction ridge width condition (expansion or no change) is a determinant of buccolingual ridge width and height changes 4 months following extraction and ridge preservation.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Buccolingual ridge width
timeFrame: (1) After local anesthesia and before extraction, (2) immediately after extraction and (3) 4 months after extraction and alveolar ridge preservation
measure: Ridge height
timeFrame: (1) After local anesthesia and before extraction, (2) immediately after extraction and (3) 4 months after extraction and alveolar ridge preservation
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Marquette University School of Dentistry Graduate Periodontics Clinic
state: Wisconsin
Study officials:
affiliation: Marquette University
name: Vrisiis Kofina, DDS, MS
role: PRINCIPAL_INVESTIGATOR
References: