Clinical, Radiographic and Histologic Evaluation of a Novel Alveolar Ridge Reconstruction Approach in Post-Extraction Dehiscence Defects: A Case Series Study
Phase: PHASE4
Conditions: Tooth Loss
Sponsor: Gustavo Avila-Ortiz DDS, MS, PhD

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Treatment of Post-Extraction Dehisced Socket - A Case Series Study 
 
NCT02980211 
 
Updated on December 26th, 2019 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Experimental Design and Center 
 
This clinical study was designed as a prospective case series and it was conducted in compliance 
with the Preferred Reporting of Case Series in Surgery (PROCESS) guidelines. 
 
Eligibility Criteria and Recruitment Adult subjects with tooth-bound, single-rooted teeth, except 
for mandibular incisors, that were indicated for extraction, and also presented with a large 
dehiscence defect affecting at least the coronal third of the buccal bone, were eligible to 
participate in the study. Exclusion criteria were as follows: 1) any periodontal attachment loss 
greater than 1 mm affecting the interproximal sites of neighboring teeth; 2) current heavy tobacco 
use, defined as greater than 10 cigarettes per day; 3) uncontrolled diabetes mellitus, defined as 
HbA1c>7.0; 4) severe hematologic disorders; 5) organ failure; 6) uncontrolled or severe metabolic 
bone diseases or disorders; 7) previous head and neck radiotherapy or chemotherapy within the 
past 12 months; 8) intake of medications known to largely influence bone metabolism; 9) subjects 
who were pregnant at the time of screening or trying to conceive; 10) mental disabilities that may 
interfere with reading, understanding and signing the informed consent and/or with following 
studyrelated instructions. Potential subjects were required to read, understand and sign the 
consent form. In the screening visit, candidates were informed of the purpose, design and timeline 
of the study, as well as expected benefits and possible risks associated with their participation. 
 
Clinical Procedures All surgical procedures were performed by the first author (MA). Before 
starting the baseline surgical intervention, a cone beam computed tomographic (CBCT) scan (i-
CAT Next Generation, Imaging Sciences International Inc., Hatfield, PA, USA) was made. The field 
of view was approximately 6 cm at 0.3mm voxel size and the exposure factor settings were fixed 
at 120 kVp and 5 mAs for all scans. All surgical procedures were performed under local anesthesia. 
The vertical extent of the defect was measured by determining the distance from the gingival 
margin to the crestal bone on the mid-buccal using a UNC-15 probe, and subtracting the 2 mm 
that, in average, would correspond to the supracrestal soft tissue. Tooth extraction was completed 
in a minimally traumatic, flapless, fashion. Following extraction, the existence of the suspected 
dehiscence defect was confirmed; absence of a defect resulted in subject exclusion. After carefully 
elevating one papilla, usually the distal, a soft tissue ‘pouch’ was created using tunneling 
instruments around the bony defect. Subsequently, a non-absorbable dPTFE membrane (Cytoplast 
TXT-200, Osteogenics Biomedical, Lubbock, TX, USA), trimmed to the size and shape that would 
allow for complete extension over the defect, was tucked between the mucosa and the alveolar 
bone. A combination particulate bone allograft composed of a mixture of 70% FDBA and 30% 
DFDBA (enCore, Osteogenics Biomedical Inc., Lubbock, TX) was used to fill the socket up to the 
crestal level and the surrounding buccal bone housing. The socket access was sealed with an 
extension of the dPTFE membrane to ensure compartmentalization of the underlying alveolar 
bone and grafting material. An external cross mattress and a simple interrupted suture (Cytoplast 
5/0 suture, Osteogenics Biomedical Inc., Lubbock, TX) were applied to stabilize the marginal 
mucosa and the elevated papilla, respectively. Detailed post-operative instructions were given to 
the subjects, including care to avoid mechanical disturbance or excessive pressure of the surgical 
site and to avoid brushing the area for one week. Additionally, prescriptions were provided to each 
patient for an anti-inflammatory medication (Ibuprofen 600 mg, every 6 to 8 hours for 48 hours, 

then as needed), a systemic antibiotic (Amoxicillin 500 mg every 8 hours for 7 days or, in case of 
penicillin allergy, Clindamycin 300 mg every 6 hours for 7 days) and a mouth rinse (Chlorhexidine 
gluconate 0.12% to be used every 12 hours). Subjects were recalled at 1, 2, 5 and 20 weeks to 
assess healing and level of discomfort. At 1 week, the sutures were removed. At 5 weeks, the 
dPTFE membrane was gently removed from ARP sites using a cotton forceps without 
administration of local anesthesia. At 20 weeks, a second CBCT was obtained for data analysis and 
to plan the implant placement procedure. 
 
Outcome of Interest and Data Collection Alveolar Bone Volume Change Two independent 
examiners assessed the magnitude of volumetric reduction of the alveolar bone in mm 3 to 
express it as a percent of change from baseline to 20 weeks. The CBCT datasets (DICOM files) were 
imported into a software package (Simplant 17 Pro, Materialise, Dentsply Implants, Waltham, MA, 
USA). A constant threshold was used to separate the soft and hard tissue elements and manual 
segmentation using reproducible landmarks was performed to select a volume of interest (VOI) 
on both datasets. The VOI was confined to the following boundaries: a horizontal plane at the 
apical extent of the root tip or guiding landmark at the equivalent location when the tooth was 
not present (apical boundary), the alveolar crest (coronal boundary), the buccal and palatal plates 
of the alveolar bone (bucco-lingual boundaries), and vertical planes placed at the location of the 
interproximal height of contours of the adjacent crowns (mesio-distal boundaries). Volume of each 
VOI was computed automatically. 
 
Statistical Analyses Given the nature of this study, no formal sample size calculation was 
conducted. A minimum sample size of 15 subjects was based on feasibility according to the low 
rate of large dehiscence defects reported in the existing literature. Data was uploaded to a 
statistical analysis software (SAS 9.4, IBM, Armonk, NY, USA). Normality was verified using the 
Shapiro-Wilk test. Measurements obtained by two examiners were averaged. Subsequently, mean 
and standard deviation was calculated for all variables. One sample t-tests were completed to 
determine whether the change in bone volume was significant (alpha was set to 0.05).