| 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
|
|
|
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
|
|
|
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. |