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Implant Placement in Combination With Connective Tissue Grafting (CTG_implant)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03728283
Recruitment Status : Completed
First Posted : November 2, 2018
Last Update Posted : November 5, 2018
Information provided by (Responsible Party):
Danae A. Apatzidou, Aristotle University Of Thessaloniki

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).

Condition or disease Intervention/treatment Phase
Dental Implant Placement Procedure: implant placement in combination with connective tissue grafting Other: Implant placement Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, randomised, parallel-group, controlled clinical trial (Altman et al. 2001) with allocation ratio 1:1,
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tissue Changes Following Connective Tissue Grafting and Two-stage Implant Placement. A Randomised Clinical Trial
Actual Study Start Date : January 10, 2014
Actual Primary Completion Date : April 30, 2016
Actual Study Completion Date : July 30, 2016

Arm Intervention/treatment
Active Comparator: Conventional Implant placement
conventional implant placement following the manufacturer's instructions
Other: Implant placement
Implants were placed following teh manufacturer's instructions

Experimental: Implant and Connective tissue grafting
implant placement in combination with connective tissue grafting
Procedure: implant placement in combination with connective tissue grafting
A connective tissue graft of standardised dimensions was harvested from the palate under local anaesthesia and was stabilised over the implant's neck

Primary Outcome Measures :
  1. Mucosa thickness [ Time Frame: implant placement to implant exposure ]
    measured by bone sounding on the alveolar crest and at 2- and 4 mm apically, both on the buccal and the lingual aspects

Secondary Outcome Measures :
  1. Width of keratinised mucosa [ Time Frame: Implant placement to implant exposure ]
    measured on the mid-buccal aspect of the implant site

  2. Implant to Bone Crest (I-BC) distance [ Time Frame: Implant placement to implant exposure ]
    measured at four sites, mid-buccally, mid-lingually, mesially and distally and was determined as the distance of the osseous crest from the implant platform.

  3. Thickness of the buccal and lingual bone [ Time Frame: Implant placement to implant exposure ]
    measured at the level of the implant shoulder and at 3- and 6 mm apically, using a customised metallic calliper (Ustomed, Tuttlingen, Germany). The inner part of one jaw firmly touched the periphery of the screw hole within the implant fixture and the opposing jaw firmly touched the osseous surface of the alveolar ridge at the predetermined depth.

  4. radiographic Implant to Bone Crest (I-BC) distance [ Time Frame: Implant placement to implant exposure ]
    Intraoral digital radiography and the VixWin™ Platinum Gendex software (Hatfield, PA, USA) was utilised to linearly assess the I-BC distance on the mesial/distal aspect at T0 and T1. The long-cone paralleling technique was used at a distance of 10 cm between the x-ray head and the digital sensor which was attached to a custom-made silicone bite block for reproducible radiographs.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Danae A. Apatzidou, Assistant Professor, Aristotle University Of Thessaloniki Identifier: NCT03728283    
Other Study ID Numbers: AUTh_5/30-09-2014
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: November 5, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Danae A. Apatzidou, Aristotle University Of Thessaloniki:
connective tissue graft
implant surgery
two-stage implants
mucosa thickness
crestal bone