Esthetic Outcomes of Single Immediate Implant Placement With Immediate Restoration Performed With Two Surgical Techniques
Phase: NA
Conditions: Gingival Recession, Bone Loss, Alveolar
Sponsor: Columbia University

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Title: Esthetic Outcomes of Single Immediate Implant Placement with Immediate Restoration 
Performed with Two Surgical Techniques 
Abbreviated title: Esthetic Outcomes of Single Immediate Implant Placement  
 
Research question(s):  
1. Primary goal is to study the effect of the surgical technique (flap elevation or flapless) on 
the change in soft tissue (papillary height and facial margin level) between pre-operative 
level and up to 12-18 months following immediate implant placement and crown 
temporization. 
2. Second goal is to study the effects of surgical technique (flap or flapless) and 
horizontal/vertical extraction socket dimensions on the lateral ridge dimensions and 
interproximal bone level adjacent to the implant 12-18 months following surgery.  
Scientific abstract:  
Immediate implant placement following tooth extraction has become a predictable method of 
therapy. Advantage of this method combined with immediate temporization, is evident in the 
maxillary esthetic zone, since it allows most continuous support of soft tissue contour. Surgical 
implant placement can be accomplished following elevation of a soft tissue flap or with a 
flapless approach. Numerous studies have demonstrated alveolar ridge remodeling with net 
bone loss at 6 months following elevation of flap (Schropp and Isidor, 2008, Buser et al., 2011). 
It is not clear, how this finding affects clinical changes in ridge dimensions (soft and hard tissue). 
Several uncontrolled trials have reported outcomes using the flapless technique (Raes et al., 
2011, Van de Velde et al., 2010, Block et al., 2009), but no randomized controlled studies 
comparing these two methods are available. The aim of this study is to compare 1) the 
remodeling of the gingival tissue margin (change in papillary distance, gingival margin level / 
recession), and 2) the dimensional changes of the ridge and the stability of the radiographic 
alveolar bone level following immediate implant placement, temporization and restoration with or 
without flap elevation.  
Lay abstract:  
In implant dentistry, immediate implant placement is a reliable and predictable treatment. For 
patients who need implant therapy in the anterior region of the mouth, length of therapy and 
esthetic outcomes are of primary concern. Currently, one of the two surgical techniques are 
utilized for implant placement: flap elevation method or flapless method. However, there are no 
prospective longitudinal studies comparing the advantages and disadvantages of these two 
techniques on soft and hard tissue stability in the area. The aim of this study is to compare 
biological (soft and hard tissue remodeling) and esthetic outcomes of the two techniques. 
Study Purpose and Rationale: 
Introduction of the immediate implant concept is attributed to Schulte (1976). The earliest 
clinical case reports were published about 20 years ago (Lazzara, 1989, Ross et al., 1989). 
Today immediate implant placement has been established as a reliable and predictable therapy, 
with similar survival and success rates to delayed implantation (Schropp et al., 2003, Block et 
al., 2009). Survival rates for both procedures included in a recent systematic review exceeded 

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95% (Chen et al; 2009). Comparison of histological healing has demonstrated no significant 
difference in bone to implant contact in immediate and delayed implant placement (Paolantonio 
et al., 2001). Teeth scheduled for extraction and immediate implantation, as a result of 
extensive caries, endodontic failures, root perforations and fractures, often present with 
radiographic evidence of previous infections, in form of periapical radiolucency. No significant 
differences have been shown between implants placed in healthy versus previously infected 
extraction sockets, in terms of success and survival rates (Novaes and Novaes, 1995, Villa and 
Rangert, 2005, Lindeboom et al., 2006, Siegenthaler et al., 2007, Crespi et al., 2010, Waasdorp 
et al., 2010) and histological results (Novaes et al., 1998, Novaes et al., 2003, Shabahang et al., 
2003, Chang et al., 2009), as long as the site is thoroughly debrided following removal of the 
tooth, primary implant stability is achieved, and in most cases, some type of antibiotic coverage 
is introduced. 
 
Soft tissue dynamics following immediate versus delayed implant placement has been the 
subject of a recent systematic review, where risk indicators for gingival recession in conjunction 
with immediate implant placement included thin biotype, facial malposition of the implant and 
thin or damaged facial wall (Chen et al., 2009). Patient level satisfaction with esthetic outcomes 
in immediate implant placement was generally high, though a scarcity of studies evaluating 
objective parameters was evident. In a prospective case series of 35 immediate implants and 
immediate restorations followed for 12 months, mean in buccal and papillary soft tissue height 
were -0.55±0.53mm midbuccal and -0.53±0.39mm changes or less interproximal, with most of 
the difference between pre-operative levels to final measurements occurring prior to the 
permanent restoration of the implants at 6 months, resulting in later soft tissue stability and high 
patient satisfaction (Kan et al., 2003). A recent prospective, though not randomized, study of 16 
immediate versus 23 conventionally placed implants demonstrated relative stability of the buccal 
margin up to 52 weeks following immediate implant placement and restoration, while the 
conventional, staged approach resulted in significant buccal recession, amounting to mean 
1mm loss of midbuccal soft tissue height after one year of function (Raes et al., 2011). 
Moreover, in the immediate group, the flapless subgroup demonstrated significantly less 
recession than the flap subgroup at 26 and 52 weeks. Although a comparison between surgical 
techniques in immediate implantation was not the primary aim of this study, we are not aware of 
other published studies investigating the question. Therefore, we propose to conduct a study of 
the effect of the surgical technique (flap or flapless) on the change in soft tissue (papillary height 
and facial margin level) between pre-operative position and up to 12-18 months following 
surgery. 
Intentional palatal orientation of immediate implants in maxillary anterior extraction socket or 
central to palatal orientation of immediate implant in bicuspid extraction socket usually results in 
a residual horizontal gap between the implant shoulder and the buccal aspect of the socket. 
This horizontal gap is referred to as Horizontal Defect Dimension (HDD). Width of HDD is 
dependent not only on the diameter of the extracted root at a given level and the position of the 
osteotomy, but also on the diameter of the selected implant to replace the tooth. The 
significance of the width of HDD on the healing has been addressed in numerous studies, with 
earlier studies suggesting threshold of 1.5mm or less (Akimoto et al., 1999, Wilson et al., 1998) 
for optimal bone to implant contact and, possibly, beneficial effect on osseointegration. 
Regenerative materials, bone grafts and barrier membranes, have been used in the past to 
address the gap between implant and bone at the time of immediate implantation, even in cases 
of intact buccal and interproximal bone levels, with rationale of epithelial exclusion from the 

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healing site, preservation of the ridge dimensions and maintenance of soft tissue stability (Chen 
et al., 2007, Araujo et al., 2011). However, a number of studies demonstrated successful 
immediate implant outcomes without use of grafting materials (Paolantonio et al., 2001, Covani 
et al., 2004, Sanz et al., 2010), including histological evaluation and confirmation of predictable 
new bone formation in HDD of up to 2 mm (Paolantonio et al., 2001). In addition, wider HDD (up 
to 3 mm) healing with new bone, following extraction and immediate implant placement has also 
been demonstrated in clinical studies (Schropp et al., 2003; (Botticelli et al., 2004). Favorable 
peri-implant soft tissue healing, including post-operative midfacial gingival margin and papillary 
height at 12 months, as well as high patient satisfaction were reported in a prospective study 
evaluating immediate implant placement and temporization, without utilization of grafts or barrier 
membranes (Kan et al., 2003). 
Immediate implant placement does not preclude vertical and horizontal alveolar ridge loss 
following the extraction. In a study of hard tissue changes following immediate implant 
placement in 21 human extraction sites, significant postsurgical dimensional alterations were 
noted at 4 months following implant surgery (horizontal resorption amounting to 56% of the 
buccal bone and 30 % of the lingual bone), in spite of predictable new bone formation at the 
inner side of the extraction socket (Botticelli et al., 2004). Mucoperiosteal flaps were elevated in 
this study prior to extraction and implant placement. Elevation of full thickness flap induces 
accelerated bone remodeling of alveolar bone and net bone loss in the range of 0.5-1.0mm 
between 3 and 6 months following surgery (Donnenfeld et al., 1964, Wood et al., 1972, Pennel 
et al., 1967, Moghaddas and Stahl, 1980, Gomez-Roman, 2001). The question then arises, 
whether flapless immediate implantation will result in diminished horizontal bone loss, entailing 
enhanced ridge stability during the first 6 months following surgery. Therefore, the second aim 
of our study is to investigate the impact of surgical technique and extraction socket dimensions 
on the changes of the lateral ridge dimension and the interproximal bone level adjacent to the 
implant up to 12-18 months following surgery. 
Summary of Study Purpose 
1. To study the effects of the surgical technique on the soft tissue changes following 
extraction and immediate implant placement and temporization over a 12-18-month 
period. 
2. To study the effects of the surgical technique and the horizontal/vertical defect 
dimension on the dimensional changes of the lateral ridge and the interproximal bone 
over a 12-18-month period. 
Study Design and Statistical Procedures Overview 
We propose to conduct a randomized controlled trial with two treatment arms: one in which 
immediate implant placement after tooth extraction is carried out after conventional 
mucoperiosteal flap elevation, and another that will adopt a flapless approach. Only maxillary 
teeth in the esthetic zone will be included. The primary outcome of the study is the gingival 
margin alterations at 12-18 months after surgery while the secondary outcome is the 
dimensional changes of the ridge at 12-18 months. 
Power Calculations and Statistical Analysis 
Based on similar data published in the literature, we have calculated that 17 subjects per group 
need to be recruited in order to have 80% power to detect a 0.5mm difference in soft tissue 

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changes between the two experimental groups. We plan to enroll a total of 40 subjects to 
account for potential dropout. Differences in the primary and secondary outcomes (changes in 
soft tissue, ridge dimension and bone level) overtime within each group will be examined as 
follows: continuous measurements will be summarized using mean/SD or median (interquartile 
range) for non-normal data. Differences between the two groups will be assessed using two 
sided t-test (means) or Wilcoxon Rank-Sum test (medians). Categorical measurements will be 
summarized using proportions. Differences between the two groups will be assessed using chi-
square test or Fisher’s Exact test for small counts. 
Study Procedures 
After informed consent is obtained, and initial periodontal therapy, whenever indicated, the 
scheduled extraction will be carried out without flap elevation, and the socket will be debrided 
meticulously. After verification that the local anatomical inclusion criteria are met, patients will be 
randomized to one of two treatment groups, a test (flapless group) and a control group (flap 
group). In the test group, the implant will be placed according to standard protocol at a position 
engaging the palatal wall without elevation of a mucoperiosteal flap In the control group, 
intrasulcular incisions will be carried out from one tooth distal to one tooth mesial to the 
extraction site and full thickness flaps will be elevated with periosteal elevator, including the 
papillae. The implant will be placed according to standard protocol at a position engaging the 
palatal wall, and the flaps will be sutured using a combination of interrupted and mattress 
sutures. 
In both groups, temporary restorations will be delivered immediately after implant placement 
provided that the implant shows primary stability and has engaged in the bone with an insertion 
torque of 25Ncm or more (Norton, 2004). In case of a lower insertion torque, the protocol will be 
abandoned, a cover screw will be placed, and a two stage implant protocol will be followed. All 
patients will be advised to receive a permanent restoration 6 months after surgery, if the implant 
is deemed to be successful (Misch et al., 2008). 
All patients will receive antibiotics 1 hour prior to surgery (Amoxicillin 1g; in allergic patients 
Clindamycin 300mg) and will continue with Amoxicillin 500mg (Clindamycin 150 mg) tid for 
seven days following surgery. All patients will be seen 1 week following surgery (suture removal 
visit, if applicable), review of OH; at two weeks following surgery, follow up of healing and OH; 
at 4 weeks, 6 weeks and 8 weeks (prophylaxis and measurements); at 3 months (prophylaxis 
and measurements); at 6 months (prophylaxis, measurements; removal of temporary 
restorations and impressions for permanent prosthesis,which will be delivered subsequently, 
can be done by restorative dentist or student at this visit or later) and at 12-18 months 
(prophylaxis, measurements). 
Research Procedures 
A reference notch will be made on the temporary crown with #1/2 bur at a 2 mm distance from 
the gingival margin at the mesiobuccal, midbuccal and distobuccal sites. The following 
measurements will be carried out:  
1)Soft tissue distance from each of the three notches (mesiobuccally, midbuccally and 
distobuccally, respectively) at implant placement visit, following suturing, 4weeks, 6 weeks, 8 
weeks, 3 months and 6 months. At 12-18 months these measurements will be performed using 
acrylic stent recoding previous reference points.  

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2a) Horizontal defect dimension (HDD) defined as horizontal distance from the implant shoulder 
to the alveolar socket wall, measured in 3 sites: mesial, buccal and distal; measured only at 
implant placement visit.  
2b) Vertical defect dimension (VDD) defined as vertical distance from implant shoulder to the 
apical contact with the socket wall, measured in 3 sites: mesial, buccal and distal; measured 
only at implant placement visit.  
2c) Buccal soft tissue and buccal plate thickness will be measured following the extraction using 
digital calipers (one measurement/ midbuccal/6mm apical to gingival margin); measured at 
implant placement only.  
2d) Pocket depth (PD): pocket depth is defined as the distance from the gingival margin to the 
tip point of the probe (Williams probe). PDs will be measured at 6 sites per tooth, (mesiobuccal, 
midbuccal, distobuccal, distopalatal, midpalatal, mesiopalatal); measured before surgery and at 
6months and 12-18 months.  
2e) Buccal dimension of the ridge at the site of implant placement: measured after implant 
placement during surgery, at 3 months, 6 months and at 12-18 months.  
2f) Impressions for study models will be taken first visit, following implant placement and 
temporization (on the day of surgery), at 8 weeks, 6 months and 12-18 months.  
3) Interproximal bone level: a film holder with silicon putty to aid in reproducibility of the 
radiograph position will be used. The mesial and distal crestal bone level will be measured using 
the MIPACS software. Implant platform will serve as the reference point. Vertical and horizontal 
changes (depth and width of the vertical defect on the mesial and/ or distal aspect of the 
implant, if present) will be measured from radiographs taken at the time of completion of 
surgery, at 6 months and 12-18 months. Dose and frequency of x-rays in the study are standard 
of care for any implant patient in CDM or in standard clinical practice, and are not altered for the 
purpose of the study. (Medical status is updated and recorded at each CDM visit, including 
verification that female patients are not pregnant prior to x-ray taking; this is also standard of 
care).  
4) The diameter of the apical radiolucency, when initially present, will be monitored 
/radiographically at will be assessed immediately after surgery at 6 months and at 12-18 
months. 
Study Instruments 
We will use periodontal probe, used in routine periodontal therapy and caliper, used in 
restorative dentistry for linear distance measurements. Impressions and subsequent stone 
model construction are used routinely for diagnostic procedures in dentistry. Reproducibility of 
x-rays will be afforded by bite registration with impression putty, used in restorative dentistry. 
Changes on x-rays will be measured using MIPACS software, routinely used for dental patient 
care in CDM. 
Additional Data Collection 
Patients will fill out CDM medical and dental history forms, which will be reviewed orally as well, 
to identify inclusion criteria (patients over age of 18 years old, systemically healthy or controlled 

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common systemic conditions) and exclusion criteria (pregnancy, smokers over 10 
cigarettes/day, parafunction or intent of orthodontic therapy). 
Study Subjects 
Forty subjects will be recruited among the patients attending the Clinic for Graduate 
Periodontics, College of Dental Medicine, Columbia University, who are in need of a tooth 
extraction at the maxillary premolar, canine and incisor region, and subsequent single implant 
placement. The reasons for extraction will include poor endodontic prognosis and/or non-
restorable teeth (extensive caries, traumatic fractures, fractures of endodontically treated teeth, 
root perforation, root resorption, with or without radiographic periapical lesion up to 5 mm in 
diameter). 
Inclusion Criteria 
• 
Age 18 or older  
• 
Systemically healthy patients or patients with controlled common systemic conditions 
(controlled hypertension, controlled diabetes HbA1c up to 7.5 %).  
• 
Presence of both adjacent teeth  
• 
Esthetically acceptable buccal gingival margin position prior to surgery, compared to 
neighboring teeth and contralateral tooth.  
• 
Radiographic bone level distance from CEJ interproximally up to 5 mm.  
• 
Location of buccal alveolar crest within 4 mm from the free gingival margin, verified after 
the extraction, before randomization; and fenestration, if present, up to 5mm in diameter 
at the apical part of the root and affecting less than 50% of the buccal socket wall. 
Exclusion Criteria 
• 
Pregnancy  
• 
Current smoking exceeding 10 cigarettes/day  
• 
Severe parafunctional habits  
• 
Malocclusion or intent of orthodontic therapy in the future  
• 
Teeth scheduled for extraction due to advanced periodontal disease 
Recruitment 
Forty subjects will be recruited among the patients attending the Clinic for Graduate 
Periodontics, College of Dental Medicine, Columbia University, who are in need of a tooth 
extraction in the maxillary premolar, canine and incisor region, and subsequent single implant 
placement. Patients will be screened by one of the investigators (Jaclyn Glick, Janet Stoupel 
and Panos Papapanou); only these investigators will be obtaining the informed consent form. If 
additional investigators will be included in the study, we will apply for an IRB modification prior 
to their participation in the study. 
Confidentiality of Study Data 
Patients are assigned identifying codes that are linked to all collected study data, stored in a 
secured database by the Primary Investigator. PHI/PII is not stored on a multi-user system, and 
PHI/PII is stored on an endpoint device that is password-protected and encrypted. The following 
individuals/ institutions/ representatives will have access to the records: the Principal 
Investigator and co-investigators, the FDA, the Department of Human Health and Human 

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Services agencies, the Columbia University/New York Presbyterian Hospital, including the 
Institutional Review Board, the implant company sponsoring the implants, Biomet 3i and it's 
representatives. Absolute confidentiality cannot be guaranteed because of potential need to 
share this information with the above parties. The aggregate results of this study, with 
preservation of patient confidentiality, may be used for teaching, meeting presentation or 
publishing purpose. 
Location of Study 
All therapy will be performed at the Postdoctoral Dental Clinics, College of Dental Medicine. 
Potential Risks 
1) Study related risks: Initial infection, pain or esthetically adverse outcome related to 
implant placement; inability to stabilize the implant due to poor quality of bone; implant 
failure and need for removal; discomfort in function and/or lack of satisfaction with the 
restoration for other reasons.  
2) Protection against risks: All efforts will be made to minimize risks to all and every 
participant: only sites with healthy or almost healthy bone levels will qualify for the study 
to avert esthetic concerns, prophylactic antibiotics to prevent post-operative infection will 
be prescribed, restorative and functional expectations will be discussed and explained. 
Potential Benefits 
Patients will benefit from extraction of a tooth with hopeless prognosis, performed at no cost. 
They will benefit from the reduced cost of the implant and temporary restoration, that otherwise 
may not be available to them as option of therapy. 
Alternative Therapies 
Alternative Procedures:  
1) not to replace the extracted tooth  
2) to receive a removable partial denture to replace the missing tooth  
3) to receive fixed crowns/bridge on adjacent teeth to replace the missing tooth  
4) to delay implant placement for up to 6 months following extraction  
5) not to have temporary crown made, following implant placement, but to have a removable 
temporary replacement. This option will be followed, if the implant does not attain initial stability 
of at least 25 Ncm. 
 
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