Clinical trial NCT04437797: Soft Tissue Outcomes of Badly Broken-down Teeth Treated With Surgical Extrusion Compared With Immediate Implant Placement
Official title: Soft Tissue Outcomes of Badly Broken-down Teeth Treated With Surgical Extrusion Compared With Immediate Implant Placement: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Broken Teeth
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-06-18
Enrollment: 26
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Soft tissue outcome
timeFrame: 12 months
Secondary outcomes:
measure: Survival
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Ismail T Mansour, B.D.S.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Bach N, Baylard JF, Voyer R. Orthodontic extrusion: periodontal considerations and applications. J Can Dent Assoc. 2004 Dec;70(11):775-80.
citation: 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.
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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.