Comparison of Two Different Alveolar Ridge Preservation Techniques

Loss of Teeth Due to Extraction Clinical Trial

Official title:

Comparison of Two Different Alveolar Ridge Preservation Techniques

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02482987
• Other study ID #: 408953-1
• Status: Enrolling by invitation
• Phase: N/A
• First received: June 19, 2015
• Last updated: February 6, 2017
• Start date: July 2015
• Est. completion date: July 2018

Study information

• Verified date: February 2017
• Source: Eisenhower Army Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare two barrier membrane products, Cytoplast (dPTFE) and BioXclude (human amnion chorion allograft), for their relative efficacies in dental socket preservation procedures, both when the socket is filled and overfilled with freeze dried bone allograft (FDBA).

Description:

This single-blind, randomized clinical trial aims to compare two different, commercially available materials to assess their relative efficacies in socket preservation procedures after tooth extraction. Patients presenting with single teeth deemed clinically hopeless and treatment planned for removal in the normal course of clinical dentistry will be considered for this study. If eligible, a ridge/socket preservation procedure will be performed at the time of extraction. Periodontics residents will perform the procedure under the supervision of board certified staff. Patients will be randomized via concealed random number sequence into one of four groups, based on a combination of materials and graft placement techniques. Patients will be equally distributed into the following groups: (1) dense polytetrafluoroethylene (Cytoplast) (2) Cytoplast with additional buccal augmentation/onlay graft, (3) human amniotic-tissue derived membrane (BioXclude), and (4) BioXclude with additional buccal augmentation/onlay graft. All four treatment groups are consistent with the current standard of care, and this study seeks to compare techniques and materials as part of routine, clinical/periodontal therapy in order to determine superiority. Approximately 150 patients will be enrolled and distributed equally among the four groups. Any post-operative complications will be managed and documented during follow-up appointments at 1, 2 and 4 weeks. Cone beam computed tomography (CBCT) will be used as the primary assessment tool, and scans will be compared between a pre-operative baseline time point and a scan taken after 4 months of healing to prepare for implant placement. The primary dependent variables will be (1) percent of baseline alveolar ridge changes (both horizontal and vertical) and (2) whether or not the anticipated dental implant could be placed appropriately. Secondary outcomes include ease of use, perceptions of pain, complications, cost-effectiveness, and changes in keratinized tissue.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 150
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• All active duty military patients (age 18-65) referred to the investigators' facility's periodontics department for diagnosis of "hopeless" tooth with documented confirmation of diagnosis by periodontal staff

• Eligible for extraction and ridge preservation (adequately healthy and not otherwise disqualified)

Exclusion Criteria:

• Pregnant or breastfeeding

• History of allergy to involved products

• Current acute infection at the site (chronic periapical infections will not exclude the patient)

• Elian Type 3 extraction sockets

• Sites not treatment planned for implant therapy

• Third molar sites

• American Society of Anesthesiology Category III patients (medically compromised)

• Active duty military patients in a student status

Related Conditions & MeSH terms

• Loss of Teeth Due to Extraction
• Tooth Loss

Intervention

Device:
• dense polytetrafluoroethylene (dPTFE) membrane Cytoplast
ridge preservation intervention using the dPTFE membrane device
• human amniotic-tissue derived membrane BioXclude
ridge preservation intervention using the dPTFE membrane device

Procedure:
• Ridge Preservation with overlay graft
ridge preservation intervention with additional freeze dried bone allograft (FDBA) placed buccal to the socket
• Ridge Preservation without overlay graft
ridge preservation without overlay graft / traditional FDBA placement into the socket only

Locations

Country	Name	City	State
United States	Tingay Dental Clinic	Fort Gordon	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Eisenhower Army Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sedation utilization	presence or absence of sedation drugs during the procedure	intra-operative surgical variable (determined in advance, at baseline)
Other	Cost	cost/benefit for each product	0-4 months
Primary	Alveolar Ridge Width	Alveolar ridge dimensional change (horizontal) from Cone beam CT	from baseline to final cone beam CT scan (approximately 4 months)
Primary	Alveolar Ridge Height	Alveolar ridge dimensional change (vertical) from cone beam CT	from baseline to final cone beam CT scan (approximately 4 months)
Secondary	Post-operative pain perception	self-report by patient on visual analog scale	1 week after surgical extraction procedure
Secondary	Platform size of implant placed	Whether or not the originally intended implant size could be placed	Implant surgery, approximtely 4 months after baseline
Secondary	Keratinized tissue width (baseline)		pre-op / baseline assessment (after randomization)(prior to time=0)
Secondary	Keratinized tissue width (final)		from pre-op assessment at time of randomization to implant surgery (4 months)
Secondary	Elian classification (anticipated)	Operators will report an anticipated socket preservation classification according to Elian 2007	pre-op / baseline assessment (after randomization)(prior to time=0)
Secondary	Elian classification (actual)	Operators will report the actual socket preservation classification according to Elian 2007	intra-operative surgical finding (extraction surgery)(time=0)
Secondary	Buccal plate thickness	intra-operative measurements, presence or absence of a dehiscence / fenestration	intra-operative surgical finding (extraction surgery)(time = 0)
Secondary	Buccal plate fenestration	determined at time of extraction surgery, and noted as a possible confounding variable	intra-operative surgical finding (extraction surgery)(time = 0)
Secondary	Complications after surgery (infection)	infection, determined by presence of purulence, lymphadenopathy and/or febrile status	0-4 months
Secondary	Complications after surgery (membrane exfoliation)	dichotomous variable, presence or absence of the membrane for the duration of the study	0-4 months
Secondary	Peri-operative clinician's report (extraction difficulty)	subjective extraction difficulty, as reported by the clinician	intra-operative surgical finding (extraction surgery)