Implant Placement in Combination With Connective Tissue Grafting

NCT03728283 | Completed

• 1 other identifier: AUTh_5/30-09-2014
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

Brief Summary

Suitable subjects who were in need of implant placement were randomised between two groups; Group-A (NA=23) received crestal implant placement. In Group-B (NB=23) a CTG harvested from the palate was stabilised over the implant-neck. At the time of implant placement (T0), Groups were categorized as having thin mucosa ≤2.5mm at the surgical site, or thick mucosa \>2.5mm. Mucosa thickness, width of keratinised tissue (WKT), crestal bone levels and bone thickness were determined at T0 and at the two-stage surgery (T1).

Conditions

Dental Implant Placement

Keywords

connective tissue graft; implant surgery; two-stage implants; mucosa thickness; crestal bone

Outcome Measures

Primary Outcomes (1)

• Mucosa thickness

  measured by bone sounding on the alveolar crest and at 2- and 4 mm apically, both on the buccal and the lingual aspects

  implant placement to implant exposure

Secondary Outcomes (4)

• Width of keratinised mucosa

  Implant placement to implant exposure

• Implant to Bone Crest (I-BC) distance

  Implant placement to implant exposure

• Thickness of the buccal and lingual bone

  Implant placement to implant exposure

• radiographic Implant to Bone Crest (I-BC) distance

  Implant placement to implant exposure

Study Arms (2)

Conventional Implant placement

ACTIVE COMPARATOR

conventional implant placement following the manufacturer's instructions

Other: Implant placement

Implant and Connective tissue grafting

EXPERIMENTAL

implant placement in combination with connective tissue grafting

Procedure: implant placement in combination with connective tissue grafting

Interventions

implant placement in combination with connective tissue grafting PROCEDURE

A connective tissue graft of standardised dimensions was harvested from the palate under local anaesthesia and was stabilised over the implant's neck

Implant and Connective tissue grafting

Implant placement OTHER

Implants were placed following teh manufacturer's instructions

Conventional Implant placement

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• above 18 years of age
• no active periodontal disease (Plaque Index ≤15%, Gingival Index ≤20%, \<20% of sites equal to or deeper than 5mm).

You may not qualify if:

• medical conditions that contraindicated surgical implant placement,
• medication that interfered with bone metabolism,
• pregnancy or lactation,
• inadequate dimensions of the alveolar ridge or grafted bone at the surgical site,
• tooth extraction 3 months prior to the study.

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Related Publications (2)

• Liu CL, Weisgold AS. Connective tissue graft: a classification for incision design from the palatal site and clinical case reports. Int J Periodontics Restorative Dent. 2002 Aug;22(4):373-9.

  PMID: 12212684 RESULT

• Papapetros D, Karagiannis V, Konstantinidis A, Apatzidou DA. Interim tissue changes following connective tissue grafting and two-stage implant placement. A randomized clinical trial. J Clin Periodontol. 2019 Sep;46(9):958-968. doi: 10.1111/jcpe.13159. Epub 2019 Jul 24.

  PMID: 31206749 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Prospective, randomised, parallel-group, controlled clinical trial (Altman et al. 2001) with allocation ratio 1:1,

Study Record Dates

• First Submitted: October 31, 2018
• First Posted: November 2, 2018
• Study Start: January 10, 2014
• Primary Completion: April 30, 2016
• Study Completion: July 30, 2016
• Last Updated: November 5, 2018

Record last verified: 2018-11