Soft Tissue Outcomes of Badly Broken-down Teeth Treated With Surgical Extrusion Compared With Immediate Implant Placement

Broken Teeth Clinical Trial

Official title:

Soft Tissue Outcomes of Badly Broken-down Teeth Treated With Surgical Extrusion Compared With Immediate Implant Placement: A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04437797
• Other study ID #: 21/4/2020
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2020
• Est. completion date: September 2021

Study information

• Verified date: June 2020
• Source: Cairo University
• Contact: Ismail T Mansour, B.D.S.
• Phone: 00201003361428
• Email: ismail.mansour[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 26
• Est. completion date: September 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Broken Teeth
• Tooth Fractures

Intervention

Procedure:
• Surgical Extrusion
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.
• Immediate Implant Placement
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (13)

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. Review. — View Citation

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

Belser UC, Grütter 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 . — View 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. — View Citation

Gómez-de Diego R, Mang-de la Rosa Mdel R, Romero-Pérez MJ, Cutando-Soriano A, López-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. Review. — View 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. Review. — View 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. — View 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. — View 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. Review. — View 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. Review. — View 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. — View 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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Soft tissue outcome	Pink esthetic score: 0-1-2 scoring system, 0 being the lowest, 2 being the highest value	12 months
Secondary	Survival	Tooth and Implant survival (binary)	12 months