NCT04437797

Brief Summary

Many patients suffer from badly decayed anterior teeth mostly in young age, causing esthetics and functional issues. This may be due to more than cause as fights, contact sports, accidents and falls. However; implant placement might not be the treatment of choice in some situations such as: medically compromised patients with absolute contraindications for implant placement or requiring extensive augmentation procedures, growing patients, patients with financial limitations, in addition to patients living in rural areas with no access for CBCT machines. Moreover, clinicians must be aware of cost-to-benefit ratios when attempting to recommend a specific treatment modality, especially in patients having financial limitations. Regarding the aforementioned conditions, surgical extrusion might be considered a cost-effective 'often overlooked' alternative compared to immediate single-tooth implant placement. Regarding healing time, cost, soft and hard tissue outcomes, surgical extrusion may be a good alternative yielding better soft tissue results as we preserve the natural tooth with the whole periodontium.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 18, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

June 18, 2020

Status Verified

June 1, 2020

Enrollment Period

1 year

First QC Date

June 15, 2020

Last Update Submit

June 17, 2020

Conditions

Broken Teeth

Outcome Measures

Primary Outcomes (1)

  • Soft tissue outcome

    Pink esthetic score: 0-1-2 scoring system, 0 being the lowest, 2 being the highest value

    12 months

Secondary Outcomes (1)

  • Survival

    12 months

Study Arms (2)

Surgical Extrusion

EXPERIMENTAL

The next step will be atraumatic extraction which will be initiated by using straight periotome until it is sufficiently luxated and gently pulled out to the amount of sufficient ferrule effect without encroaching the biological width. 90- or 180-degrees rotation of the tooth will be done if needed. The tooth will be supported from palatal side, etching will be done using 37% phosphoric acid, rinsing, drying, bonding agent and then application of 3M Filtek flowable composite on rounded 16mm stainless steel wire for splinting in the middle of the tooth without extension of flowable composite neither to the mesial nor to the distal. This procedure should be followed by occlusal adjustment if needed. Splint will be removed after 2 weeks.

Procedure: Surgical Extrusion

Immediate Implant Placement

ACTIVE COMPARATOR

The patient is anaesthetized. Atraumatic extraction of the badly broken-down teeth will be performed using peroiotome. Luxation should be done mesiodistally and not buccolingually, 11 to avoid damaging the buccal plate. After tooth removal, a curette is used to confirm that the location of the buccal plate is intact. Standard drilling procedures are performed according to the manufacturer's instructions. Then the implant is placed in the prepared site. Temporization should be done using composite 3M Filtek Z250 XT material. Finally, a porcelain fused to zirconia crown will be performed. Jumping gap occurring subsequent to atraumatic extraction and immediate implant placement more than 2 mm will be grafted using Xenograft.

Procedure: Immediate Implant Placement

Interventions

Surgical ExtrusionPROCEDURE

The next step will be atraumatic extraction which will be initiated by using straight periotome until it is sufficiently luxated and gently pulled out to the amount of sufficient ferrule effect without encroaching the biological width. 90- or 180-degrees rotation of the tooth will be done if needed. The tooth will be supported from palatal side, etching will be done using 37% phosphoric acid, rinsing, drying, bonding agent and then application of 3M Filtek flowable composite on rounded 16mm stainless steel wire for splinting in the middle of the tooth without extension of flowable composite neither to the mesial nor to the distal. This procedure should be followed by occlusal adjustment if needed. Splint will be removed after 2 weeks.

Surgical Extrusion
Immediate Implant PlacementPROCEDURE

The patient is anaesthetized. Atraumatic extraction of the badly broken-down teeth will be performed using peroiotome. Luxation should be done mesiodistally and not buccolingually, 11 to avoid damaging the buccal plate. After tooth removal, a curette is used to confirm that the location of the buccal plate is intact. Standard drilling procedures are performed according to the manufacturer's instructions. Then the implant is placed in the prepared site. Temporization should be done using composite 3M Filtek Z250 XT material. Finally, a porcelain fused to zirconia crown will be performed. Jumping gap occurring subsequent to atraumatic extraction and immediate implant placement more than 2 mm will be grafted using Xenograft.

Immediate Implant Placement

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients at 20-40 years old and have no history of periodontal disease. (periodontally healthy patients)
  • Single rooted teeth; should be single with adjacent intact or restored neighboring teeth. More than one tooth may be included in the same arch.
  • More than 1:1 crown root ratio, so that the crown to root ratio is 1:1 after extrusion and restoration

You may not qualify if:

  • Badly broken-down teeth with active signs of infection.
  • Teeth with vertical root fracture.
  • Teeth with severely tapered root.
  • Diabetic patients, assessed by measuring glycosylated hemoglobin (HbA1c). Patients with an HbA1c level greater than 8 will be excluded.
  • Potentially uncooperative patients who are not willing to go through the proposed interventions.
  • Moderate-to-heavy daily smokers\* (who report consuming at least 11 cigarettes/day). 9
  • History of radiation therapy and/or chemotherapy to the head and neck, or bone augmentation to implant site.
  • Labial cortical bone fenestration diagnosed from CBCT.
  • Patients with systemic disease that may affect normal healing.
  • Psychiatric problems, emotional instability, and unrealistic esthetic demands.
  • Bruxism.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (13)

  • Bastone EB, Freer TJ, McNamara JR. Epidemiology of dental trauma: a review of the literature. Aust Dent J. 2000 Mar;45(1):2-9. doi: 10.1111/j.1834-7819.2000.tb00234.x.

    PMID: 10846265BACKGROUND

  • Gomez-de Diego R, Mang-de la Rosa Mdel R, Romero-Perez MJ, Cutando-Soriano A, Lopez-Valverde-Centeno A. Indications and contraindications of dental implants in medically compromised patients: update. Med Oral Patol Oral Cir Bucal. 2014 Sep 1;19(5):e483-9. doi: 10.4317/medoral.19565.

    PMID: 24608222BACKGROUND

  • Clokie CM, Yau DM, Chano L. Autogenous tooth transplantation: an alternative to dental implant placement? J Can Dent Assoc. 2001 Feb;67(2):92-6.

    PMID: 11253297BACKGROUND

  • Mamoun JS. On the ferrule effect and the biomechanical stability of teeth restored with cores, posts, and crowns. Eur J Dent. 2014 Apr;8(2):281-286. doi: 10.4103/1305-7456.130639.

    PMID: 24966784BACKGROUND

  • Walsh JS, Kafrawy A, Roche JR. The effect of apical modification on the vitality of replanted permanent monkey teeth. ASDC J Dent Child. 1978 Mar-Apr;45(2):146-50. No abstract available.

    PMID: 96161BACKGROUND

  • Nugala B, Kumar BS, Sahitya S, Krishna PM. Biologic width and its importance in periodontal and restorative dentistry. J Conserv Dent. 2012 Jan;15(1):12-7. doi: 10.4103/0972-0707.92599.

    PMID: 22368328BACKGROUND

  • Bach N, Baylard JF, Voyer R. Orthodontic extrusion: periodontal considerations and applications. J Can Dent Assoc. 2004 Dec;70(11):775-80.

    PMID: 15588553BACKGROUND

  • Singh M, Kumar L, Anwar M, Chand P. Immediate dental implant placement with immediate loading following extraction of natural teeth. Natl J Maxillofac Surg. 2015 Jul-Dec;6(2):252-5. doi: 10.4103/0975-5950.183864.

    PMID: 27390509BACKGROUND

  • 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.

    PMID: 19228100BACKGROUND

  • Papaspyridakos P, Chen CJ, Singh M, Weber HP, Gallucci GO. Success criteria in implant dentistry: a systematic review. J Dent Res. 2012 Mar;91(3):242-8. doi: 10.1177/0022034511431252. Epub 2011 Dec 8.

    PMID: 22157097BACKGROUND

  • Misch CE, Perel ML, Wang HL, Sammartino G, Galindo-Moreno P, Trisi P, Steigmann M, Rebaudi A, Palti A, Pikos MA, Schwartz-Arad D, Choukroun J, Gutierrez-Perez JL, Marenzi G, Valavanis DK. Implant success, survival, and failure: the International Congress of Oral Implantologists (ICOI) Pisa Consensus Conference. Implant Dent. 2008 Mar;17(1):5-15. doi: 10.1097/ID.0b013e3181676059.

    PMID: 18332753BACKGROUND

  • Annibali S, Bignozzi I, La Monaca G, Cristalli MP. Usefulness of the aesthetic result as a success criterion for implant therapy: a review. Clin Implant Dent Relat Res. 2012 Mar;14(1):3-40. doi: 10.1111/j.1708-8208.2009.00234.x. Epub 2009 Aug 6.

    PMID: 19673953BACKGROUND

  • Sheng L, Silvestrin T, Zhan J, Wu L, Zhao Q, Cao Z, Lou Z, Ma Q. Replacement of severely traumatized teeth with immediate implants and immediate loading: literature review and case reports. Dent Traumatol. 2015 Dec;31(6):493-503. doi: 10.1111/edt.12201. Epub 2015 Jul 14.

    PMID: 26176171BACKGROUND

MeSH Terms

Conditions

Tooth Fractures

Condition Hierarchy (Ancestors)

Tooth InjuriesTooth DiseasesStomatognathic DiseasesWounds and Injuries

Study Officials

  • Ismail T Mansour, B.D.S.

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ismail T Mansour, B.D.S.

CONTACT

00201003361428ismail.mansour@dentistry.cu.edu.eg

Moustafa O Shehata, B.D.S.

CONTACT

00201225897482moustafa.hassan@dentistry.cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 15, 2020

First Posted

June 18, 2020

Study Start

September 1, 2020

Primary Completion

September 1, 2021

Study Completion

September 1, 2021

Last Updated

June 18, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will share