Clinical trial NCT03319758: Esthetic and Radiographic Outcomes Following Immediate Implant Placement With Thin or Dehiscence Buccal Bone Wall
Official title: Esthetic, Clinical and Patient-centered Outcomes Following Immediate Implant Placement With Thin or Dehiscence Buccal Bone Wall in the Anterior Maxilla
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Jaw, Edentulous, Partially
Acquired Absence of Single Tooth
Keywords: bone augmentation
esthetics
immediate implant
buccal bone defects
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2017-10-24
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this prospective study was to evaluate the soft and hard tissue changes of immediate implant placement with buccal bone augmentation in sites with thin labial bone wall in the anterior maxillary zone.

Detailed description: The objective of this prospective controlled clinical trial is to compare the esthetic and radiographic outcomes following immediate implant placement with thin or dehiscences buccal plate using bone augmentation in combination with an absorbable collagen membrane. Subjects in need of one implant replacing tooth to be removed in the maxilla within region 13-23 are included. At least 15 patients are recruited. No implant-supported temporary restorations are used during the first 4 months. After a screw-retained provisional phase of 2 months, a ﬁnal impression is taken at implant level and take-in definitive crown. Patients are recalled for oral hygiene maintenance and prosthetic controls every 6 months for the entire duration of the study.

Eligibility criteria: The inclusion criteria were as follows:

1. 18 to 70-year-old;
2. Stable periodontal and systemic health (American Society of Anesthesiologists classification I or II);
3. Single maxillary anterior teeth (canine to canine);
4. Bone thickness less than 1mm at 4mm apical to cementum-enamel junction (CEJ-4)；
5. Presence of adjacent nature tooth;
6. Good compliance;
7. No palatal vertical bone loss;
8. Good oral hygiene.

Exclusion criteria are as follow:

1. Uncontrolled periodontal or systemic disease;
2. General psychiatric contraindications;
3. More than 20 cigarettes per day;
4. History of head and neck radiotherapy；
5. Pregnant or expecting to be pregnant;
6. Patients with local or generalized healing limitations;
7. Bruxism or other destructive parafunctional habits;
8. Drug abuse or alcohol abuse.

Primary outcomes:
measure: Radiographic bone volume
timeFrame: Up to 10 years after baseline
Secondary outcomes:
measure: Change of Pink and white esthetic scores (PES/WES)
timeFrame: Change from baseline up to 10 years after implantation
measure: Visual analogue scale (VAS)
timeFrame: Up to 10 years after baseline
measure: Oral health impact profile shortened version (OHIP-I)
timeFrame: Up to 10 years after baseline
measure: Buccal marginal recession
timeFrame: Up to 10 years after baseline
measure: Papilla volume
timeFrame: Up to 10 years after baseline
measure: Width of keratinized gingiva
timeFrame: Up to 10 years after baseline
measure: Implant survival
timeFrame: Up to 10 years after baseline
measure: Probing depth
timeFrame: Up to 10 years after baseline
measure: Modified plaque index
timeFrame: Up to 10 years after baseline
measure: Modified bleeding index
timeFrame: Up to 10 years after baseline
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guanghua School of Stomatology,Hospital of Stomatology,Sun Yat-Sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Baoxin Huang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sarnachiaro GO, Chu SJ, Sarnachiaro E, Gotta SL, Tarnow DP. Immediate Implant Placement into Extraction Sockets with Labial Plate Dehiscence Defects: A Clinical Case Series. Clin Implant Dent Relat Res. 2016 Aug;18(4):821-9. doi: 10.1111/cid.12347. Epub 2015 Apr 27.
citation: Barone A, Ricci M, Romanos GE, Tonelli P, Alfonsi F, Covani U. Buccal bone deficiency in fresh extraction sockets: a prospective single cohort study. Clin Oral Implants Res. 2015 Jul;26(7):823-30. doi: 10.1111/clr.12369. Epub 2014 Mar 31.
citation: Aloy-Prosper A, Penarrocha-Oltra D, Penarrocha-Diago M, Penarrocha-Diago M. Dental implants with versus without peri-implant bone defects treated with guided bone regeneration. J Clin Exp Dent. 2015 Jul 1;7(3):e361-8. doi: 10.4317/jced.52292. eCollection 2015 Jul.