Clinical trial NCT03684356: Comparison of Peri-implant Tissues Using Socket Shield Technique Versus Xenograft
Official title: Comparison of the Dimensional Changes of Hard and Soft Peri-implant Tissues Around Single Immediate Post-Extraction Implants in the Esthetic Zone With Socket Shield Technique Versus Using Xenograft: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Socket Shield
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-09-25
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to clinically and radiographically evaluate the dimensional changes of soft and hard peri-implant tissues around single immediate post-extraction implants in the esthetic zone.

Detailed description: to compare the efficacy of the socket shield technique in counteracting the dimensional changes of the soft and hard peri-implant tissues to filliing the buccal gap with xenograft.

* Population (P): Patients with single non-restorable tooth in the esthetic zone.
* Intervention (I): Immediate implant placement with socket shield technique.
* Comparator (C): Immediate implant placement and filling the buccal gap with xenograft.
* Primary Outcome (O): Pink Esthetic Score (PES) (Fürhauser et al., 2005).
* Time frame: 9 months (Chu et al., 2015).
* Study design: Randomized controlled clinical trial.

Eligibility criteria: Inclusion Criteria:

1. Patient's age was 18 years or older.
2. Non-restorable tooth in the upper inter-bicuspid area.
3. Adequate bone volume for the placement of immediate implant.
4. Following tooth extraction, there was an intact socket bony wall (type I extraction socket).
5. Primary stability of the implant was achieved at the time of the implant placement.

Exclusion Criteria:

1. Patients who reported tobacco use in the past 5 years.
2. Patients who had severe periodontal destruction at the site of implant placement.
3. The presence of any signs of acute infection in the surgical site or the adjacent two natural teeth.
4. Patients who had history of any systemic disease that precludes the placement of implants.
5. Any disease that might affect bone metabolism as osteoporosis.
6. Patients taking medications that might affect bone turn over as bisphosphonates.
7. Physically or mentally handicapped patients.
8. Pregnant females.
9. Teeth with vertical root fractures on the buccal aspect
10. Teeth with any other pathologies affecting the buccal part of the root, for example, external or internal resorptions.

Primary outcomes:
measure: pink esthetic score
timeFrame: 9 months
Secondary outcomes:
measure: Recession of the buccal peri-implant mucosa
timeFrame: 9 months
measure: Corono-apical peri-implant bone dimensional changes
timeFrame: 6 months
measure: Bucco-lingual peri-implant bone dimensional changes
timeFrame: 6 months
measure: Patient satisfaction: VAS
timeFrame: 9 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Professor in Department of Oral Medicine and Periodontology
name: Amr F Zahran, Professor
role: STUDY_CHAIR
References:
citation: Baumer D, Zuhr O, Rebele S, Hurzeler M. Socket Shield Technique for immediate implant placement - clinical, radiographic and volumetric data after 5 years. Clin Oral Implants Res. 2017 Nov;28(11):1450-1458. doi: 10.1111/clr.13012. Epub 2017 Mar 23.
citation: Bramanti E, Norcia A, Cicciu M, Matacena G, Cervino G, Troiano G, Zhurakivska K, Laino L. Postextraction Dental Implant in the Aesthetic Zone, Socket Shield Technique Versus Conventional Protocol. J Craniofac Surg. 2018 Jun;29(4):1037-1041. doi: 10.1097/SCS.0000000000004419.
citation: Mitsias ME, Siormpas KD, Kotsakis GA, Ganz SD, Mangano C, Iezzi G. The Root Membrane Technique: Human Histologic Evidence after Five Years of Function. Biomed Res Int. 2017;2017:7269467. doi: 10.1155/2017/7269467. Epub 2017 Nov 22.
citation: Siormpas KD, Mitsias ME, Kontsiotou-Siormpa E, Garber D, Kotsakis GA. Immediate implant placement in the esthetic zone utilizing the "root-membrane" technique: clinical results up to 5 years postloading. Int J Oral Maxillofac Implants. 2014 Nov-Dec;29(6):1397-405. doi: 10.11607/jomi.3707. Epub 2014 Sep 26.
citation: Tan Z, Kang J, Liu W, Wang H. The effect of the heights and thicknesses of the remaining root segments on buccal bone resorption in the socket-shield technique: An experimental study in dogs. Clin Implant Dent Relat Res. 2018 Jun;20(3):352-359. doi: 10.1111/cid.12588. Epub 2018 Feb 8.
citation: Atef M, El Barbary A, Dahrous MSE, Zahran AF. Comparison of the soft and hard peri-implant tissue dimensional changes around single immediate implants in the esthetic zone with socket shield technique versus using xenograft: A randomized controlled clinical trial. Clin Implant Dent Relat Res. 2021 Jun;23(3):456-465. doi: 10.1111/cid.13008. Epub 2021 May 24.