Oval Abutment Versus a Circular Abutment in Dental Implants in the Anterior Maxillae

NCT05642520 | Completed DMC

• 1 other identifier: 2018_01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Objetive: The main objective of this clinical trial is to assess whether the oval section abutment of a 2.9mm implant achieves a greater covering of the tooth-implant papilla compared to a circular section abutment in 3.3mm implants in upper lateral incisors and lower central / lateral incisors. Material and methods: fourty patients received unitary implants of 3.3mm or 2.9 mm diameter to replace the absence of upper lateral incisor or lower central/lateral incisor with an edentulous space of at least 6.4mm (mesio-distally). Esthetic and clinical parameters were evaluated 12 months after installation of the prosthesis. Condition or disease: dental implants Intervention/treatment: 3.3 or 2.9 mm diameter dental implants Phase: Not Applicable

Conditions

Dental Implants

Outcome Measures

Primary Outcomes (1)

• The main objective was the papillary index (PI) (Jemt, 1997)

  It consists in four scores: 0 = absence of interdental papilla; 1 = filling of the interdental space less than 50% of the soft tissues; 2 = filling of the interdental space greater than 50% of the soft tissues; 3 = total filling of the interdental space with good aesthetic harmony; 4 = Hyperplasic interdental papilla formation with irregular soft tissue. Both mesial and distal papilla will be recorded.

  12 months

Secondary Outcomes (7)

• To observe the stability of the soft and hard tissues after one year in function: probing depth

  12 months

• To observe the stability of the soft and hard tissues after one year in function:bleeding on probing

  12 months

• To observe the stability of the soft and hard tissues after one year in function: suppuration on probing

  12 months

• To observe the stability of the soft and hard tissues after one year in function: Modified plaque index (MPI)

  12 months

• Assessment of survival rate of the implants

  12 months

Study Arms (2)

oval section abutment of a 2.9mm

EXPERIMENTAL

The choice of the diameter to be used as recommended by the manufacter, was determined by the mesiodistal width between the two adjacent natural teeth, in order to maintain at least 1.5mm between the implant and the adjacent tooth. When said the distance was between 5.9 and 6.3 mm, a 2.9 mm implant was placed. Implant designs are made of a titanium and zirconium alloy (Roxolid®) with a SLActive® surface (Institut Straumann AG, Basel, Switzerland).

Procedure: Circular section abutment of 3.3 mm

circular section abutment in 3.3mm

PLACEBO COMPARATOR

The choice of the diameter to be used as recommended by the manufacter, was determined by the mesiodistal width between the two adjacent natural teeth, in order to maintain at least 1.5mm between the implant and the adjacent tooth. When said the distance was between 6.4 and 7.1 mm, a 3.3 mm implant was placed. Both implant designs are made of a titanium and zirconium alloy (Roxolid®) with a SLActive® surface (Institut Straumann AG, Basel, Switzerland).

Procedure: Oval section abutment of 2.9 mm

Interventions

Oval section abutment of 2.9 mm PROCEDURE

The choice of the diameter to be used as recommended by the manufacter, was determined by the mesiodistal width between the two adjacent natural teeth, in order to maintain at least 1.5mm between the implant and the adjacent tooth. When said the distance was between 5.9 and 6.3 mm, a 2.9 mm implant was placed. Implant designs are made of a titanium and zirconium alloy (Roxolid®) with a SLActive® surface (Institut Straumann AG, Basel, Switzerland).

circular section abutment in 3.3mm

Circular section abutment of 3.3 mm PROCEDURE

The choice of the diameter to be used as recommended by the manufacter, was determined by the mesiodistal width between the two adjacent natural teeth, in order to maintain at least 1.5mm between the implant and the adjacent tooth. When said the distance was between 6.4 and 7.1 mm, a 3.3 mm implant was placed. Implant designs are made of a titanium and zirconium alloy (Roxolid®) with a SLActive® surface (Institut Straumann AG, Basel, Switzerland).

Also known as: Prosthetic treatment over a circular section abutment of 3.3.mm

oval section abutment of a 2.9mm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients \>18 years of age
• Absence of upper lateral incisors or lower central / lateral incisors with an edentulous space of at least 6.4mm (mesio-distally).
• The teeth adjacent to the edentulous space must be natural.
• Patients who are in periodontal health.
• Signing of informed consent before entering the study.

You may not qualify if:

• Patients with any systemic condition or disease that may interfere with oral surgery.
• History of radiotherapy.
• Patients smoking more than 20 cigarettes per day.
• Pregnant or breastfeeding patients.

Sponsors & Collaborators

• Ana María García de la Fuente: lead

Study Sites (1)

Department of Stomatology II. UPV/EHU

Leioa, Biscay, 48940, Spain

Location

Related Publications (9)

• Klein MO, Schiegnitz E, Al-Nawas B. Systematic review on success of narrow-diameter dental implants. Int J Oral Maxillofac Implants. 2014;29 Suppl:43-54. doi: 10.11607/jomi.2014suppl.g1.3.

  PMID: 24660189 BACKGROUND

• Patil RC, den Hartog L, van Heereveld C, Jagdale A, Dilbaghi A, Cune MS. Comparison of two different abutment designs on marginal bone loss and soft tissue development. Int J Oral Maxillofac Implants. 2014 May-Jun;29(3):675-81. doi: 10.11607/jomi.3363.

  PMID: 24818207 BACKGROUND

• Froum SJ, Natour M, Cho SC, Yu PYC, Leung M. Expanded Clinical Applications of Narrow-Diameter Implants for Permanent Use. Int J Periodontics Restorative Dent. 2020 Jul/Aug;40(4):529-537. doi: 10.11607/prd.4565.

  PMID: 32559035 BACKGROUND

• Roccuzzo A, Imber JC, Jensen SS. Need for lateral bone augmentation at two narrow-diameter implants: A prospective, controlled, clinical study. Clin Oral Implants Res. 2021 Apr;32(4):511-520. doi: 10.1111/clr.13721. Epub 2021 Mar 1.

  PMID: 33548077 BACKGROUND

• Mombelli A, van Oosten MA, Schurch E Jr, Land NP. The microbiota associated with successful or failing osseointegrated titanium implants. Oral Microbiol Immunol. 1987 Dec;2(4):145-51. doi: 10.1111/j.1399-302x.1987.tb00298.x. No abstract available.

  PMID: 3507627 BACKGROUND

• Ainamo J, Bay I. Problems and proposals for recording gingivitis and plaque. Int Dent J. 1975 Dec;25(4):229-35.

  PMID: 1058834 BACKGROUND

• Buser D, Weber HP, Lang NP. Tissue integration of non-submerged implants. 1-year results of a prospective study with 100 ITI hollow-cylinder and hollow-screw implants. Clin Oral Implants Res. 1990 Dec;1(1):33-40. doi: 10.1034/j.1600-0501.1990.010105.x.

  PMID: 2099210 BACKGROUND

• Albrektsson T, Zarb G, Worthington P, Eriksson AR. The long-term efficacy of currently used dental implants: a review and proposed criteria of success. Int J Oral Maxillofac Implants. 1986 Summer;1(1):11-25. No abstract available.

  PMID: 3527955 BACKGROUND

• Herrera-Perez P, Garcia-De-La-Fuente AM, Andia-Larrea E, Marichalar-Mendia X, Aguirre-Urizar JM, Aguirre-Zorzano LA. Clinical analysis of the tooth-implant papilla for two narrow-diameter titanium-zirconium implants in the anterior area: prospective controlled clinical study. BMC Oral Health. 2024 Mar 5;24(1):310. doi: 10.1186/s12903-024-04075-2.

  PMID: 38443879 DERIVED

Study Officials

• ANA MARIA GARCIA DE LA FUENTE, PhD

  University of the Basque Country (UPV/EHU)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The clinical monitor will hide the treatment to the clinical observer, the patient and the statistician.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: The study was a double-blind controlled clinical trial (RCT) comparing the oval section abutment of a 2.9mm (test group) to a circular section abutment in 3.3mm (control group) implants for the replacement of a single tooth. The choice of the diameter to be used as recommended by the manufacter, was determined by the mesiodistal width between the two adjacent natural teeth, in order to maintain at least 1.5mm between the implant and the adjacent tooth. When said the distance was between 5.9 and 6.3 mm, a 2.9 mm implant was placed, while if the width ranged between 6.4 and 7.1 mm, a 3.3 mm implant was placed. Both implant designs are made of a titanium and zirconium alloy (Roxolid®) with a SLActive® surface (Institut Straumann AG, Basel, Switzerland).

Study Record Dates

• First Submitted: November 18, 2022
• First Posted: December 8, 2022
• Study Start: February 1, 2018
• Primary Completion: February 1, 2023
• Study Completion: March 1, 2023
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP

Locations

ES (1)