Clinical trial NCT02922075: Impact of Soft Tissue Grafts on Tissue Alterations After Immediate Tooth Replacement
Official title: Soft and Hard Tissue Stability After Immediate Tooth Replacement With Implant in Fresh Sockets Grafted With Different Soft Tissue Grafts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tooth Socket
Dental Implants
Keywords: gingival recession
immediate implant and provisional placement
bone graft
connective tissue graft
collagen matrix
Lead sponsor: São Paulo State University
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2016-10-03
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the impact of soft tissue grafts on soft tissue recession following immediate implant, provisional and bone graft placement in compromised sockets. One third of the patients received a collagen matrix (CM group), another third received a connective tissue graft removed from the palate (CTG group) and the final third did not receive any soft tissue graft (CTL group).

Detailed description: Preventing soft tissue recession following flapless immediate implant and provisional placement (IIPP) in sockets with facial bone dehiscences is a challenge, mainly in esthetic areas. This study evaluated the impact of soft tissue grafts on peri-implant alterations after 1-year follow-up. Twenty-four patients with one single failing maxillary incisor presenting facial bone dehiscence and receiving IIPP were randomly divided in three groups (n= 8 in each group): Control (CTL); Collagen Matrix (CM); Connective tissue graft (CTG). In addition to soft tissue grafts, all groups were treated with collagen membrane and deproteinized bovine bone mineral containing 10% of porcine collagen. Clinical, photographic and tomographic analyses were performed at baseline, 6 and 12 months after surgery to evaluate tissue alterations.

Eligibility criteria: Inclusion Criteria:

* Presence of a failing maxillary incisor with neighbouring teeth and harmonic gingival contour;
* Operated area with appropriate palatal/apical bone to install the implant;
* A buccal wall defect confirmed by cone beam computed tomography;
* Clinical attachment level \> 3 mm;
* Good oral hygiene with visible plaque index \< 20%;
* No bone loss in the neighbouring teeth;
* Implant primary stability \> 32N

Exclusion Criteria:

* History of periodontal surgeries in the failing tooth;
* Occlusal instability;
* Systemic alterations that could compromise the surgical procedure, such ass smokers, bruxists; drug users; patients with diabetes or pregnants.
* Active infection involving the gingival margin
* Patients undergoing radiotherapy in the head and neck area. Patients presented history of bone associated diseases or medication affecting bone metabolism;

Primary outcomes:
measure: Periimplant marginal recession
timeFrame: 12 months after surgical procedure
Secondary outcomes:
measure: Questionnaire of Implant survival
timeFrame: 12 months
measure: Papilla migration
timeFrame: 12 months after the surgical procedure
measure: Pink esthetic score
timeFrame: 12 months after the surgical procedure
measure: Soft tissue thickness
timeFrame: 12 months after the surgical procedure
measure: Bone height
timeFrame: 12 months after the surgical procedure
measure: Modified pink esthetic score
timeFrame: 12 months after the surgical procedure
measure: Bone thickness
timeFrame: 12 months after the surgical procedure
Other outcomes:
Locations:
city: Araraquara
country: Brazil
facility: Araraquara Dental School at the São Paulo State University
state: SP
Study officials:
affiliation: Professor
name: Elcio Marcantonio Jr, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yoshino S, Kan JY, Rungcharassaeng K, Roe P, Lozada JL. Effects of connective tissue grafting on the facial gingival level following single immediate implant placement and provisionalization in the esthetic zone: a 1-year randomized controlled prospective study. Int J Oral Maxillofac Implants. 2014 Mar-Apr;29(2):432-40. doi: 10.11607/jomi.3379.
citation: Roe P, Kan JY, Rungcharassaeng K, Caruso JM, Zimmerman G, Mesquida J. Horizontal and vertical dimensional changes of peri-implant facial bone following immediate placement and provisionalization of maxillary anterior single implants: a 1-year cone beam computed tomography study. Int J Oral Maxillofac Implants. 2012 Mar-Apr;27(2):393-400.
citation: van Steenberghe D. Outcomes and their measurement in clinical trials of endosseous oral implants. Ann Periodontol. 1997 Mar;2(1):291-8. doi: 10.1902/annals.1997.2.1.291.
citation: Furhauser R, Florescu D, Benesch T, Haas R, Mailath G, Watzek G. Evaluation of soft tissue around single-tooth implant crowns: the pink esthetic score. Clin Oral Implants Res. 2005 Dec;16(6):639-44. doi: 10.1111/j.1600-0501.2005.01193.x.
citation: Belser UC, Grutter L, Vailati F, Bornstein MM, Weber HP, Buser D. Outcome evaluation of early placed maxillary anterior single-tooth implants using objective esthetic criteria: a cross-sectional, retrospective study in 45 patients with a 2- to 4-year follow-up using pink and white esthetic scores. J Periodontol. 2009 Jan;80(1):140-51. doi: 10.1902/jop.2009.080435.