Clinical trial NCT05642520: Oval Abutment Versus a Circular Abutment in Dental Implants in the Anterior Maxillae
Official title: A Randomized Controlled Clinical Trial Comparing the Placement of an Oval Abutment in 2.9 mm Implants Versus a Circular Abutment in Implants of 3.3 mm to 12 Months of Evolution
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Implants
Lead sponsor: University of the Basque Country (UPV/EHU)
Sponsor class: OTHER
First posted: 2022-12-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: TREATMENT

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

Detailed description: 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).

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.

The secondary objectives are (a) to observe the stability of the soft and hard tissues after one year in function, (b) to assess the success and survival rate of the implants, (c) to assess the stability of the implants and their evolution and (d) to analyze the degree of patient satisfaction with the aesthetic result.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: The main objective was the papillary index (PI) (Jemt, 1997)
timeFrame: 12 months
Secondary outcomes:
measure: To observe the stability of the soft and hard tissues after one year in function: probing depth
timeFrame: 12 months
measure: To observe the stability of the soft and hard tissues after one year in function:bleeding on probing
timeFrame: 12 months
measure: To observe the stability of the soft and hard tissues after one year in function: suppuration on probing
timeFrame: 12 months
measure: To observe the stability of the soft and hard tissues after one year in function: Modified plaque index (MPI)
timeFrame: 12 months
measure: Assessment of survival rate of the implants
timeFrame: 12 months
measure: Assessment of the success of the implants
timeFrame: 12 months
measure: Analyze the degree of patient satisfaction with the aesthetic result.
timeFrame: 12 months
Other outcomes:
Locations:
city: Leioa
country: Spain
facility: Department of Stomatology II. UPV/EHU
state: Biscay
Study officials:
affiliation: University of the Basque Country (UPV/EHU)
name: ANA MARIA GARCIA DE LA FUENTE, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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citation: 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.
citation: 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.