Clinical trial NCT03497403: Socket Preservation Procedure Studying Soft and Hard Tissue Outcomes
Official title: Socket Preservation Revisited: RCT to Study the Three-dimensional Changes of Hard and Soft Tissue Comparing Two Distinct Surgical Protocols
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ridge Preservation
Bone Regeneration
Lead sponsor: Harvard School of Dental Medicine
Sponsor class: OTHER
Collaborators: name: Valeant Pharmaceuticals
First posted: 2018-04-13
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were assigned to one of two groups in parallel for the duration of the study.
Primary purpose: TREATMENT

Brief summary: Two different surgical protocols for socket preservation were compared. Soft and hard tissue outcomes were measured clinically and radiographically at baseline and six months post operatively.

Detailed description: The effect of different surgical techniques for socket preservation on soft tissue parameters has seldom been investigated. The aim of this study was to evaluate One with a cross-linked membrane used in secondary intention healing and the other with a non-cross-linked membrane used in primary intentional healing. Thirty subjects requiring tooth extraction were randomly allocated to either control group C (allograft covered with a non-cross-linked collagen membrane with primary closure) or experimental group E (allograft covered with cross-linked collagen membrane left exposed). Sites were surgically re-entered at 6-months. Soft and hard tissue measurements, cone beam computed tomography (CBCT) and cast measurements were taken at baseline \& 6-months.

Eligibility criteria: Inclusion Criteria:

1. between 20-80 years of age
2. healthy with no conditions that could alter wound healing
3. requiring the extraction of a non-molar tooth with two neighboring teeth on either side and intact bony walls
4. a tooth requiring extraction that is treatment planned for implant placement
5. willing to participate in the study and sign the informed consent
6. willing to receive clinical exams, radiographs, surgery, two and six week post-operative exams and six month re-entry exam.

Exclusion Criteria:

1. systemic conditions which could alter wound healing
2. tooth anatomy requiring aggressive bone removal or greater flap reflection for extraction
3. severe local infection at extraction site
4. a tooth exhibiting severe resorption of buccal or lingual plates
5. absence of keratinized tissue buccal to the tooth to be extracted
6. severely reduced vestibular depth (≤ 3.0 mm) at the tooth to be extracted.

Primary outcomes:
measure: Keratinized tissue width
timeFrame: 6 months
Secondary outcomes:
measure: Keratinized tissue thickness
timeFrame: 6 months
measure: Vestibular Depth
timeFrame: 6 months
measure: CEJ-FGM
timeFrame: 6 months
measure: Ridge Width
timeFrame: 6 months
measure: CEJ- Buccal crest
timeFrame: 6 months
measure: CBCT bone height
timeFrame: 6 months
measure: CBCT bone width
timeFrame: 6 months
measure: Cast ridge width
timeFrame: 6 months
measure: Cast ridge volume
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Harvard School of Dental Medicine
state: Massachusetts
Study officials:
affiliation: Harvard School of Dental Med.
name: Eli Machtei, DMD
role: PRINCIPAL_INVESTIGATOR
References: