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CTRI Number  CTRI/2025/06/088295 [Registered on: 05/06/2025] Trial Registered Prospectively
Last Modified On: 04/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   Comparative assessment of the gingival status and alveolar bone level between flap and flapless implant surgery  
Scientific Title of Study   Comparative assessment of the gingival status and alveolar bone level between flap and flapless surgical technique with immediate placement of healing abutment over dental implant a randomized controlled clinical trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ashish Khadia 
Designation  MDS student  
Affiliation  Aligarh Mushlim University 
Address  opd no. 2 pg section department of periodontics and community dentistry
nil
Aligarh
UTTAR PRADESH
202002
India 
Phone  09899066547  
Fax    
Email  ashishkhadia8@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  vivek kumar sharma 
Designation  professor 
Affiliation  Aligarh Mushlim University 
Address  opd no. 2 pg section department of periodontics and community dentistry
nil
Aligarh
UTTAR PRADESH
202002
India 
Phone  09899066547  
Fax    
Email  amuperio@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Ashish Khadia 
Designation  MDS student  
Affiliation  Aligarh Mushlim University 
Address  opd no. 2 pg section department of periodontics and community dentistry
nil
Aligarh
UTTAR PRADESH
202002
India 
Phone  09899066547  
Fax    
Email  ashishkhadia8@gmail.com  
 
Source of Monetary or Material Support  
dr. ziauddin ahmed dental college and hospital, aligarh mushlim university, aligarh, uttar pradesh, india, pincode 202002 
 
Primary Sponsor  
Name  nil 
Address  nil 
Type of Sponsor  Other [] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ashish Khadia  dr. ziauddin ahmed dental college and hospital / aligarh mushlim university  department of periodontics and community dentistry/pg section/room no. 2
Aligarh
UTTAR PRADESH 
09899066547

ashishkhadia8@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
national ethics committee registry for biomedical and healthy research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  healthy humans with edentulous space 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  conventional flap implant surgery  assesment of gingival recession after 1 week , 4 weeks, 12 weeks and alveolar bone loss after 1 week, 4 weeks, 12 weeks with conventional flap implant surgery 
Comparator Agent  flapless implant surgery  assesment of gingival recession after 1 week, 4 weeks, 12 weeks and alveolar bone loss after 1 week, 4 weeks,12 weeks using flapless implant surgery 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Edentulous premolars/ 1st molar/2nd molar site in maxilla/mandible.
A sufficient width of bone measuring a minimum of 4.5 mm near the crest (the distance measured between the apical ends of the first thread of the implant to the most coronal point of the interproximal crestal bone at the mesial and distal aspect of the implant)
The presence of keratinized soft tissue width of minimum 2 mm.
 
 
ExclusionCriteria 
Details  Subjects with any type of comorbidities or individual risk factors will not be included in the study.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Gingival recession and Alveolar bone level will be measured on radiograph.  1.baseline gingival recession
2. 4 weeks gingival recession and alveolar bone loss
3. 12 weeks gingival recession and alveolar bone loss 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   15/06/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Dental implant therapy has been demonstrated to be a highly successful and predictable treatment modality for replacement of missing teeth.1 However, achieving implant aesthetics remains a challenge with respect to re-creating a natural appearing gingival margin and papilla. With the rapid advancement of dental implant therapeutics, the current trend is more geared toward enhancing aesthetics and patient comfort and satisfaction. Papilla preservation and predictable soft tissue margins around dental implants are major aesthetic concerns, particularly for patients who have a high smile line. There has been a report of postsurgical tissue loss from flap reflection2, implying that flap surgery for implant placement may negatively influence implant aesthetic outcomes, especially in the anterior maxilla. One technique to overcome this concern is flapless implant placement with immediate healing abutment.

This technique involves removing a small amount of tissue over the crest of the edentulous ridge, just sufficient to expose the underlying bone to facilitate implant placement. As a consequence, no sutures are required, and no soft tissue flap is reflected, potentially reducing postoperative discomfort and swelling3. This is in contrast to the traditional flap approach with immediate healing abutment, in which an incision is made through the gingiva along the crest of the ridge, and the gingival tissue is reflected away from the underlying bone to allow access for implant placement. The traditional technique requires suturing; potentially involves more postoperative bleeding, discomfort, and swelling; and may result in a compromised aesthetic result due to the potential bone loss and recession associated with raising a flap4.

A study in beagle dogs compared buccal bone plate resorption between flapless and flap approaches to implant placement5. At 3 months, the flapless approach resulted in 0.67 mm less buccal bone resorption than the flap approach. This study and several other clinical trials in humans provide evidence that a flapless approach may provide some additional advantages over traditional flap implant placement protocols and could have a use in regular clinical practice 5-10. One study directly comparing the two surgical approaches evaluated bone density surrounding the implants over a period of 18 months and found no difference among the study groups11. Another study evaluating the flap versus flapless approach found no difference in either survival rates or bone density (as measured using radiograph) among the groups10. Fewer studies are available to provide information on aesthetic outcomes and other measures of implant success versus merely survival. In 2006, one group used a flapless surgical approach to compare early versus delayed loading of implants8. The results of that study indicated that a flapless approach results in an aesthetic soft tissue profile that is stable for up to 6 months.

     Since the flapless approach is a relatively new treatment approach, data regarding healing patterns of peri-implant tissues, implant survival/success rates, and Aesthetic outcomes are not sufficient in the literature1. Although some studies have compared outcomes between the flapless and traditional flap approach, Aesthetic outcomes have not been a major focus. Hence, the primary objective of this randomized controlled study is to compare clinical outcomes of flapless implant surgery with healing abutment with those of traditional flap implant placement with immediate healing abutment.

 
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