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Tooth SocketPhase 4NCT02922075

Impact of Soft Tissue Grafts on Tissue Alterations After Immediate Tooth Replacement

A Phase 4 study testing Connective tissue graft, Collagen matrix graft and Immediate implant in people with Tooth Socket and Dental Implants, run by São Paulo State University at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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)… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Tooth Socket, Dental Implants
What is being tested?
Connective tissue graft, Collagen matrix graft and Immediate implant
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
1 siteBrazil
Study dates
Feb 2013to Jun 2015
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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;

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Araraquara Dental School at the São Paulo State University

    Araraquara, São Paulo, 14801-903

Other trials in Brazil

About this study

Official title: Soft and Hard Tissue Stability After Immediate Tooth Replacement With Implant in Fresh Sockets Grafted With Different Soft Tissue Grafts

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).

Read the 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.

Being tested
Connective tissue graft, Collagen matrix graft, Immediate implant, Tooth extraction, Immediate restoration
Keywords
gingival recession, immediate implant and provisional placement, bone graft, connective tissue graft, collagen matrix
Medical subject headings
Gingival Recession

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Connective tissue graftBiological

    Also called autogenous subepithelial connective tissue graft

    A 1.5 mm thick soft tissue graft removed from the palate with determined dimensions. The recipient site was prepared by performing laterally a delicate elevation of the facial tissue avoiding the mesial and distal papilla. The soft tissue graft length was equal to the horizontal distance between the two papillas and its length was set at 6 mm. Soft tissue grafts were placed at the level of the gingival margin and stabilized with simple interrupted sutures.

  • Collagen matrix graftBiological

    Also called heterogenous graft

    A 15x20 mm collagen matrix trimmed according to determined dimensions. The recipient site was prepared by performing laterally a delicate elevation of the facial tissue avoiding the mesial and distal papilla. The soft tissue graft length was equal to the horizontal distance between the two papillas and its length was set at 6 mm. Soft tissue grafts were placed at the level of the gingival margin and stabilized with simple interrupted sutures.

  • Immediate implantDevice

    A conical implant with a morse-taper connection with moderate roughness implant surface was properly installed in the ideal tridimensional position with its platform placed 4 mm below the facial gingival margin. After tooth extraction and dental implant installation with a torque > 32 Ncm patients were randomized into three groups (8 patients per group): 1- No soft tissue graft, Control group (CTL); 2- Collagen Matrix group (CM); 3- Connective tissue graft group (CTG).

  • Tooth extractionProcedure or surgery

    Compromised tooth was gently removed and the socket was debrided thoroughly, cleansed and inspected. The socket's palatal and apical bone was sequentially drilled. All surgeries were performed by the same surgeon and were individually planned according to the clinical and tomographic evaluation. Implant diameter was set as 3.5 mm and its length was selected according to the quantity of bone available apically to the fresh alveolar socket.

  • Immediate restorationDevice

    A titanium abutment was installed in the dental implant with manual torque and a prefabricated tooth shell was relined with resin material to fabricate cement or screw retained interim restoration. All interim restorations were installed in infra-occlusion matching the adjacent teeth color and form, with light proximal contacts and presented a subgingival concave contour.

  • Bone regenerationBiological

    Also called Bio-Oss Collagen®, Bio-Gide®

    All sites received a non-cross linked collagen membrane and deproteinized bovine bone mineral containing 10% of porcine collagen.

  • Post operative medicationDrug

    Also called Amoxicillin, Paracetamol, Chlorhexidine

    Postoperative instructions were given, antibiotics were prescribed for 7 days (amoxicillin 500 mg t.i.d), analgesics to relieve from pain (Paracetamol 750 mg) and chlorhexidine 0.12% rinse twice a day for 15 days. Complementary, the patients were instructed to avoid chewing in the anterior region and to follow a soft diet.

  • Definitive prosthesisDevice

    Also called Zirconia abutment and ceramic crown installation

    Definitive implant-supported restorations were performed 6 months after dental implant placement.

  • No soft tissue graftOther

    No soft tissue graft was used

Study groups in NCT02922075
Study groupRoleWhat they receive
CTLPlacebo comparatorNo soft tissue graft was used. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis.
Receives: Device: Immediate implant; Procedure: Tooth extraction; Device: Immediate restoration; Biological: Bone regeneration; Drug: Post operative medication; Device: Definitive prosthesis; Other: No soft tissue graft
CMExperimentalPatient received a collagen matrix graft. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis.
Receives: Biological: Collagen matrix graft; Device: Immediate implant; Procedure: Tooth extraction; Device: Immediate restoration; Biological: Bone regeneration; Drug: Post operative medication; Device: Definitive prosthesis
CTGExperimentalPatient received a connective tissue graft. It was performed tooth extraction, immediate implant, immediate restoration, bone regeneration, post operative medication and definitive prosthesis.
Receives: Biological: Connective tissue graft; Device: Immediate implant; Procedure: Tooth extraction; Device: Immediate restoration; Biological: Bone regeneration; Drug: Post operative medication; Device: Definitive prosthesis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Periimplant marginal recession

    Periimplant marginal recession in millimeters 12 months after the surgical procedure.

    Measured: 12 months after surgical procedure

Secondary outcomes (7)

  1. Questionnaire of Implant survival

    Evaluation of implant survival

    Measured: 12 months

  2. Papilla migration

    Evaluation of mesial and distal papilla migration in millimeters 12 months after the surgical procedure

    Measured: 12 months after the surgical procedure

  3. Pink esthetic score

    Evaluation of pink esthetic scores

    Measured: 12 months after the surgical procedure

  4. Soft tissue thickness

    Evaluation of soft tissue thickness in millimeters 12 months after the surgical procedure

    Measured: 12 months after the surgical procedure

  5. Bone height

    Evaluation of bone height in millimeters in contact with the implant 12 months after the surgical procedure

    Measured: 12 months after the surgical procedure

  6. Modified pink esthetic score

    Evaluation of gingival esthetics

    Measured: 12 months after the surgical procedure

  7. Bone thickness

    Evaluation of bone thickness in millimeters in contact with the implant 12 months after the surgical procedure

    Measured: 12 months after the surgical procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2016 (estimated)
  2. Study startFeb 2013
  3. Primary completionDec 2013
  4. Study completionJun 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02922075
Sponsor's protocol ID
São Paulo State University
Status last verified
Sep 2016
First submitted
24 Sep 2016
Last updated
3 Oct 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 24683571

  • 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.

    PubMed 22442780

  • 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.

    PubMed 9151562

  • 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.

    PubMed 16307569

  • 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.

    PubMed 19228100

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Connective tissue graft, Collagen matrix graft and Immediate implant in people with Tooth Socket and Dental Implants, run by São Paulo State University at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Periimplant marginal recession (time frame: 12 months after surgical procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02922075, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2016; AzTrials last refreshed its copy on 7 Nov 2026.

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